Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-01-22 @ 8:22 AM
Study NCT ID:
NCT03326206
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sshin@bwh.harvard.edu', 'phone': '617-872-0310', 'title': 'Dr. Sonya Shin', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is an observational study using routine clinical data for endpoints other than patient-reported outcomes. Therefore, the participant flow and adverse event reporting did not conform to clinical trial protocols. For patient-reported outcomes, we used mixed methods (including pre-post surveys among a sub-set of COPE participants and qualitative interviews) but did not collect or compare data from a control arm.'}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'Because this study was an observational, prospective study, adverse events are reported based on routine clinical data during the study period: 1) all-cause mortality; 2) serious adverse events defined as incident cardiovascular disease; 3) non serious adverse events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 54, 'seriousNumAtRisk': 173, 'deathsNumAffected': 8, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .', 'otherNumAtRisk': 2885, 'deathsNumAtRisk': 2885, 'otherNumAffected': 493, 'seriousNumAtRisk': 2885, 'deathsNumAffected': 92, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Inpatient hospitalization', 'notes': 'Any inpatient hospitalization event, due to any cause.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 145, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 2885, 'numEvents': 790, 'numAffected': 493}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Incident CVD', 'notes': 'acute myocardial infarction, coronary artery bypass surgery, coronary angioplasty, peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, cerebrovascular disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2885, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Percentage of Glycated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2880', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'groupId': 'OG000', 'lowerLimit': '-0.62', 'upperLimit': '-0.37'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.17'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A priori threshold for statistical significance \\< 0.05', 'groupDescription': 'Mixed linear regression models were performed to assess differences over time for continuous variables, comparing COPE versus control groups. The models included a random effect for patients to account for within-patient correlation over time in the outcome measures and a random effect for the primary health facility, to account for within-site correlation. In the sensitivity analyses we also adjusted the models for the random effect of matching groups.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed linear regression'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Change in Hemoglobin A1c measured at 24 months, compared with baseline', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2880', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '2.18'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.50'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance p\\<0.05', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed linear regression as described in primary endpoint'}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Changes in systolic blood pressure at 24 months, compared with baseline', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Low-density Lipoprotein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2880', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.04', 'groupId': 'OG000', 'lowerLimit': '-11.88', 'upperLimit': '-4.20'}, {'value': '-3.21', 'groupId': 'OG001', 'lowerLimit': '-4.17', 'upperLimit': '-2.24'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significant p\\<0.05', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed linear regression as described in primary endpoint'}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Change in low density lipoprotein at 24 months, compared with baseline', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2880', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '0.01'}, {'value': '-0.26', 'groupId': 'OG001', 'lowerLimit': '-0.34', 'upperLimit': '-0.18'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for significance p\\<0.05', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed linear regression model as described for primary endpoint'}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'change in body mass index at 24 months, compared with baseline', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Primary Outpatient Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0750', 'groupId': 'OG000', 'lowerLimit': '0.9618', 'upperLimit': '1.2016'}, {'value': '0.9224', 'groupId': 'OG001', 'lowerLimit': '0.8952', 'upperLimit': '0.9505'}]}]}], 'analyses': [{'pValue': '0.0091', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Primary result is coefficient on post intervention change in visits by COPE pts relative to controls: if significant and \\>0, COPE visits have increased relative to controls; if significant and \\<0, COPE visits have decreased relative to controls.', 'groupDescription': 'Generalized linear mixed regression models were used for count outcomes (SAS 9.3: PROC GLIMMIX) to estimate change in health care visits by COPE pts relative to non-COPE pts. Random effects accounted for within-site correlation at service units. Adjusted for covariates: age, gender, language, primary care physician, and diagnoses: essential hypertension, major depression disorder, alcohol abuse, major cardiovascular disease, and dyslipidemia.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Primary outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Specialty Outpatient Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8856', 'groupId': 'OG000', 'lowerLimit': '0.7720', 'upperLimit': '1.0160'}, {'value': '0.6838', 'groupId': 'OG001', 'lowerLimit': '0.6610', 'upperLimit': '0.7074'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'As described for primary outpatient services', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Specialty outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Emergency Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2755', 'groupId': 'OG000', 'lowerLimit': '0.2306', 'upperLimit': '0.3290'}, {'value': '0.2559', 'groupId': 'OG001', 'lowerLimit': '0.2448', 'upperLimit': '0.2674'}]}]}], 'analyses': [{'pValue': '0.4296', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'as described for primary outpatient services', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Emergency encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Counseling / Behavioral Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2590', 'groupId': 'OG000', 'lowerLimit': '0.2164', 'upperLimit': '0.3101'}, {'value': '0.1432', 'groupId': 'OG001', 'lowerLimit': '0.1363', 'upperLimit': '0.1504'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'As described for primary outpatient services', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Counseling / behavioral encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Laboratory Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3510', 'groupId': 'OG000', 'lowerLimit': '0.2838', 'upperLimit': '0.4341'}, {'value': '0.2798', 'groupId': 'OG001', 'lowerLimit': '0.2650', 'upperLimit': '0.2955'}]}]}], 'analyses': [{'pValue': '0.0431', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Laboratory encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Radiology Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0304', 'groupId': 'OG000', 'lowerLimit': '0.0222', 'upperLimit': '0.0416'}, {'value': '0.0220', 'groupId': 'OG001', 'lowerLimit': '0.0202', 'upperLimit': '0.0240'}]}]}], 'analyses': [{'pValue': '0.0516', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Radiology encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'encounters per patient per quarter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pharmacy Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5477', 'groupId': 'OG000', 'lowerLimit': '0.4816', 'upperLimit': '0.6229'}, {'value': '0.5146', 'groupId': 'OG001', 'lowerLimit': '0.4977', 'upperLimit': '0.5321'}]}]}], 'analyses': [{'pValue': '0.3582', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Pharmacy encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Inpatient Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1869', 'groupId': 'OG000', 'lowerLimit': '0.1436', 'upperLimit': '0.2433'}, {'value': '0.1592', 'groupId': 'OG001', 'lowerLimit': '0.1491', 'upperLimit': '0.1699'}]}]}], 'analyses': [{'pValue': '0.2461', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'For inpatient services, the primary data point is the presence of a DRG code indicating the patient was hospitalized. However, we also included clinic listings for labor and delivery and for observation as inpatient utilization.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Dental Encounters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals living with diabetes seen at a study site who were enrolled in the COPE programmatic intervention during the study period.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1119', 'groupId': 'OG000', 'lowerLimit': '0.0875', 'upperLimit': '0.1429'}, {'value': '0.1422', 'groupId': 'OG001', 'lowerLimit': '0.1344', 'upperLimit': '0.1505'}]}]}], 'analyses': [{'pValue': '0.0613', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Dental encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Community Encounters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '2885', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period.'}, {'id': 'OG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1160', 'groupId': 'OG000', 'lowerLimit': '0.0900', 'upperLimit': '0.1497'}, {'value': '0.0189', 'groupId': 'OG001', 'lowerLimit': '0.0171', 'upperLimit': '0.0207'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Community encounters are identified using the Resource Patient Management System (RPMS) clinic variable. Community Encounters may include public health nursing and community health representative visits; however, not all community encounters (e.g. visits by Community Health Representatives in clinics where Community Health Representatives do not document their visits on the RPMS system) may be represented in this database', 'unitOfMeasure': 'number of visits per quarter post enroll', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient-reported Good Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants - baseline', 'description': 'Survey data administered to patients at the time of enrollment into the COPE Program'}, {'id': 'OG001', 'title': 'COPE participants - 12 months', 'description': 'Surveys administered to patients after 1 year of participation in the COPE program'}], 'classes': [{'title': 'Good health', 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Good health compared to a year ago', 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Good health compared to other people your age', 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Health status is assessed by three questions using a 5-point scale response to the General Health question from the Short Form 12 survey: "Would you say that in general your health is…" "Compared to your health a year ago, would you say your health is" and "Compared to other people your age, would you say your health is" (Excellent=5, Very Good=4, Good=3, Fair=2, Poor=1), where higher values are more favorable.\n\nBinary outcome of Good Health includes "Excellent," "Very good" and "Good" as yes, other responses as no.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient-reported Sense of Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants - baseline', 'description': 'Survey data administered to patients at the time of enrollment into the COPE Program'}, {'id': 'OG001', 'title': 'COPE participants - 12 months', 'description': 'Surveys administered to patients after 1 year of participation in the COPE program'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value corresponds to patient-reported health compared to a year ago and compared to others their age', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Sense of control is assessed using a 4-point scale response to the question "Do you feel you are in control of your health?" (Always Never=1, Rarely=2, Sometimes=3, Almost Always=4) with a higher value representing a favorable outcome. Binary outcome derived by including "Almost Always" in "Yes" and "Always never," "Rarely" and "Sometimes" in "No"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient-reported Ability to Cope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COPE participants - baseline', 'description': 'Survey data administered to patients at the time of enrollment into the COPE Program'}, {'id': 'OG001', 'title': 'COPE participants - 12 months', 'description': 'Surveys administered to patients after 1 year of participation in the COPE program'}], 'classes': [{'title': 'Able to cope with all the things you had to do', 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Able to cope with unexpected negative events', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value corresponds with Ability to cope with negative life events', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Coping will be assessed using a 4-point scale response to two questions "how often have you found that you couldn\'t cope with all the things that you had to do to?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) and "In the last month, how often have you been upset because of something that happened unexpectedly?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) with a higher value representing a favorable outcome. Binary variables derived by grouping "Always never" and "Rarely" as "Yes" and all others responses as "No"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COPE participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'FG001', 'title': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}], 'periods': [{'title': 'Overall Study - 24 months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'COPE participants who were identified in study database', 'groupId': 'FG000', 'numSubjects': '241'}, {'comment': 'Non-COPE participants who were identified in the study database (routine electronic health records)', 'groupId': 'FG001', 'numSubjects': '28572'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Observational cohort who had data available and able to be matched', 'groupId': 'FG000', 'numSubjects': '173'}, {'comment': 'Observational cohort who had data available and able to be matched', 'groupId': 'FG001', 'numSubjects': '2880'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '25692'}]}], 'dropWithdraws': [{'type': 'Unable to match cases with controls', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22721'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Observational data not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '2879'}]}]}, {'title': '12 months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '28572'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '2880'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '25692'}]}], 'dropWithdraws': [{'type': 'Unable to match cases with controls', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22721'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Observational data not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '2921'}]}]}], 'recruitmentDetails': 'COPE participants are recruited to the program as part of routine care. Providers and CHRs identify individuals with uncontrolled chronic diseases, and invite them to participate in the program. Recruitment is programmatic, and not under research auspices.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'COPE Participants', 'description': 'Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.'}, {'id': 'BG001', 'title': 'Non-COPE Participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}], 'categories': [{'title': '18-24 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '25-40 years old', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '41-55 years old', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '610', 'groupId': 'BG001'}, {'value': '643', 'groupId': 'BG002'}]}, {'title': '56-70 years old', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '1436', 'groupId': 'BG001'}, {'value': '1510', 'groupId': 'BG002'}]}, {'title': '71-85 years old', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '764', 'groupId': 'BG001'}, {'value': '818', 'groupId': 'BG002'}]}, {'title': '> 85 years old', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '1979', 'groupId': 'BG001'}, {'value': '2087', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '901', 'groupId': 'BG001'}, {'value': '966', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian / Alaska Native', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Navajo Area Indian Health Services', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preferred language', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '2878', 'groupId': 'BG001'}, {'value': '3050', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Navajo or other Native American language', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '1178', 'groupId': 'BG001'}, {'value': '1278', 'groupId': 'BG002'}]}, {'title': 'English', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '1700', 'groupId': 'BG001'}, {'value': '1772', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing on variable in observational database'}, {'title': 'Primary Care Physician', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2880', 'groupId': 'BG001'}, {'value': '3053', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Primary Care Provider assigned', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '2577', 'groupId': 'BG001'}, {'value': '2723', 'groupId': 'BG002'}]}, {'title': 'No Primary Care Provider assigned', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Essential hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2875', 'groupId': 'BG001'}, {'value': '3048', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '1966', 'groupId': 'BG001'}, {'value': '2079', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '909', 'groupId': 'BG001'}, {'value': '969', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing on variable in observational database'}, {'title': 'Major Depressive Disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2875', 'groupId': 'BG001'}, {'value': '3048', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '2593', 'groupId': 'BG001'}, {'value': '2741', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing on variable in observational database'}, {'title': 'Major cardiovascular disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2875', 'groupId': 'BG001'}, {'value': '3048', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '2050', 'groupId': 'BG001'}, {'value': '2173', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '875', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing on variable in observational database'}, {'title': 'Dyslipidemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2875', 'groupId': 'BG001'}, {'value': '3048', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '1688', 'groupId': 'BG001'}, {'value': '1768', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '1187', 'groupId': 'BG001'}, {'value': '1280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing on variable in observational database'}, {'title': 'Alcohol Use Disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '2875', 'groupId': 'BG001'}, {'value': '3048', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '2798', 'groupId': 'BG001'}, {'value': '2960', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data missing on variable in observational database'}], 'populationDescription': 'The numbers for results differ from those of participant flow because the n for each baseline characteristic depended on data available from health record abstractions.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28813}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2017-10-24', 'resultsFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-10-27', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient-reported Good Health', 'timeFrame': '12 months', 'description': 'Health status is assessed by three questions using a 5-point scale response to the General Health question from the Short Form 12 survey: "Would you say that in general your health is…" "Compared to your health a year ago, would you say your health is" and "Compared to other people your age, would you say your health is" (Excellent=5, Very Good=4, Good=3, Fair=2, Poor=1), where higher values are more favorable.\n\nBinary outcome of Good Health includes "Excellent," "Very good" and "Good" as yes, other responses as no.'}, {'measure': 'Patient-reported Sense of Control', 'timeFrame': '12 months', 'description': 'Sense of control is assessed using a 4-point scale response to the question "Do you feel you are in control of your health?" (Always Never=1, Rarely=2, Sometimes=3, Almost Always=4) with a higher value representing a favorable outcome. Binary outcome derived by including "Almost Always" in "Yes" and "Always never," "Rarely" and "Sometimes" in "No"'}, {'measure': 'Patient-reported Ability to Cope', 'timeFrame': '12 months', 'description': 'Coping will be assessed using a 4-point scale response to two questions "how often have you found that you couldn\'t cope with all the things that you had to do to?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) and "In the last month, how often have you been upset because of something that happened unexpectedly?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) with a higher value representing a favorable outcome. Binary variables derived by grouping "Always never" and "Rarely" as "Yes" and all others responses as "No"'}], 'primaryOutcomes': [{'measure': 'Change in Percentage of Glycated Hemoglobin (HbA1c)', 'timeFrame': '24 months', 'description': 'Change in Hemoglobin A1c measured at 24 months, compared with baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': '24 months', 'description': 'Changes in systolic blood pressure at 24 months, compared with baseline'}, {'measure': 'Change in Low-density Lipoprotein', 'timeFrame': '24 months', 'description': 'Change in low density lipoprotein at 24 months, compared with baseline'}, {'measure': 'Change in Body Mass Index', 'timeFrame': '24 months', 'description': 'change in body mass index at 24 months, compared with baseline'}, {'measure': 'Change in Primary Outpatient Services', 'timeFrame': '24 months', 'description': 'Primary outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Specialty Outpatient Services', 'timeFrame': '24 months', 'description': 'Specialty outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Emergency Services', 'timeFrame': '24 months', 'description': 'Emergency encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Counseling / Behavioral Services', 'timeFrame': '24 months', 'description': 'Counseling / behavioral encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Laboratory Services', 'timeFrame': '24 months', 'description': 'Laboratory encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Radiology Services', 'timeFrame': '24 months', 'description': 'Radiology encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Pharmacy Services', 'timeFrame': '24 months', 'description': 'Pharmacy encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Inpatient Services', 'timeFrame': '24 months', 'description': 'For inpatient services, the primary data point is the presence of a DRG code indicating the patient was hospitalized. However, we also included clinic listings for labor and delivery and for observation as inpatient utilization.'}, {'measure': 'Change in Dental Encounters', 'timeFrame': '24 months', 'description': 'Dental encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.'}, {'measure': 'Change in Community Encounters', 'timeFrame': '24 months', 'description': 'Community encounters are identified using the Resource Patient Management System (RPMS) clinic variable. Community Encounters may include public health nursing and community health representative visits; however, not all community encounters (e.g. visits by Community Health Representatives in clinics where Community Health Representatives do not document their visits on the RPMS system) may be represented in this database'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Navajo', 'Community Health Workers', 'Community Health Representatives', 'Tribal health systems', 'American Indian', 'Rural', 'Health disparities'], 'conditions': ['Diabetes Mellitus', 'Metabolic Syndrome', 'Hypertension', 'Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '32450874', 'type': 'DERIVED', 'citation': 'Franz C, Atwood S, Orav EJ, Curley C, Brown C, Trevisi L, Nelson AK, Begay MG, Shin S. Community-based outreach associated with increased health utilization among Navajo individuals living with diabetes: a matched cohort study. BMC Health Serv Res. 2020 May 25;20(1):460. doi: 10.1186/s12913-020-05231-4.'}, {'pmid': '32054623', 'type': 'DERIVED', 'citation': 'Brown C, Lalla A, Curley C, King C, Muskett O, Salt S, Ray K, Begay MG, Nelson AK, Shin S. Community-clinic linkages: qualitative provider perspectives on partnering with community health representatives in Navajo Nation. BMJ Open. 2020 Feb 12;10(2):e031794. doi: 10.1136/bmjopen-2019-031794.'}, {'pmid': '31914997', 'type': 'DERIVED', 'citation': 'Lalla A, Salt S, Schrier E, Brown C, Curley C, Muskett O, Begay MG, Shirley L, Clark C, Singer J, Shin S, Nelson AK. Qualitative evaluation of a community health representative program on patient experiences in Navajo Nation. BMC Health Serv Res. 2020 Jan 8;20(1):24. doi: 10.1186/s12913-019-4839-x.'}, {'pmid': '31771603', 'type': 'DERIVED', 'citation': 'Trevisi L, Orav JE, Atwood S, Brown C, Curley C, King C, Muskett O, Sehn H, Nelson KA, Begay MG, Shin SS. Integrating community health representatives with health care systems: clinical outcomes among individuals with diabetes in Navajo Nation. Int J Equity Health. 2019 Nov 27;18(1):183. doi: 10.1186/s12939-019-1097-9.'}]}, 'descriptionModule': {'briefSummary': "Since 2009, a programmatic community-based strategy (COPE) has been implemented to address health disparities among Navajo individuals living with multiple chronic conditions. COPE (Community Outreach and Patient Empowerment) targets individual, family, and health system-level factors through four activities: 1) coordination between community health representatives (CHRs) and Indian Health Service providers; 2) CHR competency with standardized training; 3) a culturally-sensitive health promotion curriculum for patients and families; and 4) strong CHR supervision.\n\nCOPE has been implemented throughout Navajo Nation. Enrollment is programmatic; in other words, the decision to enroll a patient in COPE occurs independently of whether the patient is in this study. Participants receive the COPE intervention in the same manner and intensity, whether they are included in this observational study or not.\n\nThe main goal of this observational research is to understand if COPE improves the lives of participating community members. The Primary Aim is to assess the impact of the COPE Project on changes in HbA1c and other CVD risk factors. Hypothesis: Patients enrolled in the COPE program will experience a reduction in HbA1c compared to the control group. Secondary aims are: 1) To understand if COPE improves patients' own self-reported outcomes. Hypothesis: COPE patients will report better health compared with their own baseline at 12 months. 2) To Identify factors associated with increased effectiveness of the COPE Project at the individual, community, and health system level using a mixed-model approach. 3) To understand diverse stakeholder perspectives on COPE impact and value among CHRs, providers and the health care system. Hypothesis: Compared with baseline, CHRs will report greater empowerment in their work, providers will report greater confidence in CHRs.\n\nThe observational cohort will be comprised of individuals with diabetes receiving care at one of the participating health facilities. Cases include individuals participating in the COPE intervention; controls are non-COPE participants identified within the same hospital and matched based on similar baseline characteristics. Study findings will improve clinical and patient-decision making and the health of marginalized AI/ANs by informing policies to promote CHR interventions in rural and underserved communities.", 'detailedDescription': 'Study population: The study will take place on the Navajo Reservation and within Navajo Area IHS clinical facilities. The Navajo Reservation covers over 27,000 square miles in rural New Mexico and Arizona. The proposed evaluation will occur at the six sites, including two which are currently implementing COPE as well as four sites which will implement COPE in the next two years. The health care centers included in this evaluation represent a mix of federally and tribally operated programs and together provide care for over 200,000 individuals. All sites use a common suite of software applications to record electronic health care data: the IHS RPMS (Resource Patient Management System).\n\nStudy Design: The research is aligned with PCORI\'s definition of patient-centered research by answering questions that will allow patients and other stakeholders to make informed health care decisions. This will be completed by incorporating patient input at all stages; comparatively assessing the benefits and weaknesses of COPE; capturing the "voice" of stakeholders through qualitative methods; choosing outcomes that have been cited as relevant to patients\' own priorities and decision-making; and studying cross-site variation to capture individual and community factors associated with impact. The study will address the following questions:\n\n1. Do clinical outcomes (hemoglobin A1c, blood pressure, cholesterol, and body mass index) improve more among COPE participants, compared with similar patients who do not participate in COPE?\n2. Do COPE patients experience improvements in self-rated overall health, quality of life, empowerment and satisfaction compared with similar patients who do not participate in COPE?\n3. As COPE is implemented in six different service units across the Navajo Nation, can we identify any factors among patients, CHRs, and hospitals that are "key ingredients" for COPE to be effective?\n4. Does COPE benefit the health system and population served from diverse stakeholder perspectives including CHRs, providers, and the local health care delivery system?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals receiving care at a Navajo Area Indian Health Service facility, living with diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of diabetes\n* Treated at a participating IHS facility corresponding to their home residence\n\nExclusion Criteria:\n\n* Not seen in one of the six participating clinical sites'}, 'identificationModule': {'nctId': 'NCT03326206', 'briefTitle': 'Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program', 'orgStudyIdInfo': {'id': 'AD-1304-6566'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPE participants', 'description': 'Individuals living with diabetes seen at a study site who were enrolled in the COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs use structured patient coaching materials to support behavior change. CHRs also check vital signs, monitor blood glucose levels through finger sticks, and facilitate access to appointments and medical refills. CHRs communicate regularly with providers through electronic health record documentation and case management rounds. In-person or telephone communication is be used to address acute issues that may arise.'}, {'label': 'Non-COPE participants', 'description': 'Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86503', 'city': 'Chinle', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chinle Comprehensive Health Care Facility', 'geoPoint': {'lat': 36.15445, 'lon': -109.55261}}, {'zip': '86504', 'city': 'Fort Defiance', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tsehootsooi Medical Center', 'geoPoint': {'lat': 35.74446, 'lon': -109.07648}}, {'zip': '86033', 'city': 'Kayenta', 'state': 'Arizona', 'country': 'United States', 'facility': 'Kayenta Health Center', 'geoPoint': {'lat': 36.72778, 'lon': -110.25458}}, {'zip': '87313', 'city': 'Crownpoint', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Crownpoint Health Center Facility', 'geoPoint': {'lat': 35.67808, 'lon': -108.15118}}, {'zip': '87301', 'city': 'Gallup', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Gallup Indian Medical Center', 'geoPoint': {'lat': 35.52808, 'lon': -108.74258}}, {'zip': '87420', 'city': 'Shiprock', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Northern Navajo Medical Center', 'geoPoint': {'lat': 36.78555, 'lon': -108.68703}}], 'overallOfficials': [{'name': 'Sonya S Shin, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastern Research Group, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Physician', 'investigatorFullName': 'Sonya Sunhi Shin', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}