Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-06 @ 2:21 AM
Study NCT ID:
NCT02123251
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hawaii Patient Reward And Incentives to Support Empowerment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D015438', 'term': 'Health Behavior'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chuanc@hawaii.edu', 'phone': '8089565379', 'title': 'Dr. Chuan Chinn', 'organization': 'University of Hawaii, Center on Disability Studies'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Loss of Medicaid status led to reduced # of data points analyzed. Unequally spaced intervention period across subjects increased the variability of outcomes. Usual care setting with providers ordering lab tests led to high # of missing test results.'}}, 'adverseEventsModule': {'timeFrame': '1 year 7 months', 'description': 'The consent form detailed that participants were at no more risk than that related to standard of care. Should an adverse event have occurred due to standard of care, service providers were responsible and did not communicate any adverse events. Incentives through HI-PRAISE were based on ADA standards of care and did not increase risk. No Adverse Events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle.", 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 0, 'seriousNumAtRisk': 159, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 0, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in HbA1c From Baseline to the End of Intervention (December 2015)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0660', 'groupId': 'OG000', 'lowerLimit': '-0.2158', 'upperLimit': '0.3478'}, {'value': '-0.3440', 'groupId': 'OG001', 'lowerLimit': '-0.6546', 'upperLimit': '-0.0334'}]}]}], 'analyses': [{'pValue': '0.0553', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4100', 'ciLowerLimit': '-0.0092', 'ciUpperLimit': '0.8293', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2139', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis adjusted for the effects of age, race, gender, and baseline hypertension.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.'}, {'type': 'PRIMARY', 'title': 'Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3579', 'groupId': 'OG000', 'lowerLimit': '-3.8541', 'upperLimit': '1.1383'}, {'value': '0.9337', 'groupId': 'OG001', 'lowerLimit': '-1.9684', 'upperLimit': '3.8358'}]}]}], 'analyses': [{'pValue': '0.2416', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2916', 'ciLowerLimit': '-6.1274', 'ciUpperLimit': '1.5442', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9571', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.'}, {'type': 'PRIMARY', 'title': 'Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1895', 'groupId': 'OG000', 'lowerLimit': '-3.9359', 'upperLimit': '-0.4432'}, {'value': '-1.1002', 'groupId': 'OG001', 'lowerLimit': '-2.8352', 'upperLimit': '0.6347'}]}]}], 'analyses': [{'pValue': '0.3881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0893', 'ciLowerLimit': '-3.5632', 'ciUpperLimit': '1.3846', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2622', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.'}, {'type': 'PRIMARY', 'title': 'Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9141', 'groupId': 'OG000', 'lowerLimit': '-14.6584', 'upperLimit': '6.8303'}, {'value': '2.5709', 'groupId': 'OG001', 'lowerLimit': '-13.1754', 'upperLimit': '8.0336'}]}]}], 'analyses': [{'pValue': '0.8617', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3432', 'ciLowerLimit': '-16.4517', 'ciUpperLimit': '13.7653', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.7086', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.'}, {'type': 'PRIMARY', 'title': 'Changes in Triglycerides From Baseline to the End of Intervention (December 2015)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4843', 'groupId': 'OG000', 'lowerLimit': '-48.524', 'upperLimit': '49.4935'}, {'value': '18.2713', 'groupId': 'OG001', 'lowerLimit': '-8.7418', 'upperLimit': '45.2845'}]}]}], 'analyses': [{'pValue': '0.5333', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.7870', 'ciLowerLimit': '-73.7478', 'ciUpperLimit': '38.1737', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '28.5519', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.'}, {'type': 'PRIMARY', 'title': 'Changes in LDL From Baseline to the End of Intervention (December 2015)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4523', 'groupId': 'OG000', 'lowerLimit': '-7.3542', 'upperLimit': '6.4495'}, {'value': '1.3620', 'groupId': 'OG001', 'lowerLimit': '-8.9651', 'upperLimit': '6.2410'}]}]}], 'analyses': [{'pValue': '0.8620', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9097', 'ciLowerLimit': '-9.3509', 'ciUpperLimit': '11.1702', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.2351', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.'}, {'type': 'PRIMARY', 'title': 'Changes in HDL From Baseline to the End of Intervention (December 2015)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6705', 'groupId': 'OG000', 'lowerLimit': '-0.7934', 'upperLimit': '2.1344'}, {'value': '-0.0472', 'groupId': 'OG001', 'lowerLimit': '-1.4807', 'upperLimit': '1.3863'}]}]}], 'analyses': [{'pValue': '0.4915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7177', 'ciLowerLimit': '-1.3272', 'ciUpperLimit': '2.7626', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0433', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.'}, {'type': 'SECONDARY', 'title': 'Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive a maximum of $320 financial incentives annually based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.185', 'spread': '0.674', 'groupId': 'OG000'}, {'value': '-0.203', 'spread': '0.484', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A standard diffs-in-diffs model was utilized to estimate the causal effect of the intervention on medical costs per patient/day. The average change in cost over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the cost per patient per day from baseline to endpoint between groups.', 'statisticalMethod': 'standard diffs-in-diffs model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention)', 'description': 'Changes of total cost expenditures including emergency room use and hospitalizations in the intervention and control groups before and during intervention.', 'unitOfMeasure': 'dollars/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7796', 'groupId': 'OG000', 'lowerLimit': '0.3492', 'upperLimit': '1.2099'}, {'value': '0.1393', 'groupId': 'OG001', 'lowerLimit': '-0.3028', 'upperLimit': '0.5814'}]}]}], 'analyses': [{'pValue': '0.0420', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6403', 'ciLowerLimit': '0.0233', 'ciUpperLimit': '1.2572', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3148', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'The average change in scores over time for the intervention group was compared to that for the control group. The difference in these average changes is referred to as the difference-in-differences values which was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the General Diet subscale from baseline to endpoint between groups. Generalized estimating equation modeling was used to examine changes in SDSCA between groups at different time points.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'SDSCA is a validated, self-reported measure assessing the average # of days the recommended diabetes self-care activities are performed over the past 7 days in the areas of general diet, specific diet, exercise, blood-glucose testing, and foot care at baseline, mid, and end of intervention. Possible scores range from 0 to 7 days. Change = (End of Intervention Score - Baseline Score)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model; this provides unbiased results when missing data is random. Not all participants submitted surveys at each data point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive a maximum of $320 financial incentives annually based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5162', 'groupId': 'OG000', 'lowerLimit': '-0.8996', 'upperLimit': '1.9319'}, {'value': '-1.6027', 'groupId': 'OG001', 'lowerLimit': '-3.0495', 'upperLimit': '-0.1558'}]}]}], 'analyses': [{'pValue': '.0399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1188', 'ciLowerLimit': '0.0981', 'ciUpperLimit': '4.1395', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0310', 'estimateComment': 'The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.', 'groupDescription': 'The average change in scores over time for the intervention group was compared to that of the control group. The difference in the average changes is referred to as the difference-in-differences values which was assessed for significance at p=0.05. Null assumed no group difference in the Physical Component Summary measure of SF-36v2 from baseline to midpoint. Generalized estimating equation (GEE) modeling was used to examine changes in health measures between groups at different time points.', 'statisticalMethod': 'Generalized Estimating Equation Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The effect of age and gender is adjusted in the GEE model.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': "The SF-36v2 is validated, self reported short-form health survey used to assess changes over time in the well-being of participants. It consists of 2 component summary measures that further summarize 8 health domain scales. The Physical Component Summary (PCS) measure is derived from domain scales of Physical Functioning (10 items), Role-Physical (4 items), Bodily Pain (2 items), and General Health (5 items). Scores of component summary measures and health domain scales range from 0 to 100 with higher scores indicating better outcomes. Norm-based scoring was used so that scores for each health domain scale and component summary measure have a mean of 50 and standard deviation of 10 based on the 2009 U.S. general population. The SF-36v2 was used to assess participants' health and wellbeing at baseline, mid, and endpoint of intervention. Change = (Midpoint Score - Baseline Score)", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model; this provides unbiased results when the type of missing data is random. Not all participants submitted surveys at each data point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended American Diabetes Association (ADA) benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost Medicaid eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Switched Managed Care Organization (MCO)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study recruited 320 eligible patients from Kaiser Permanente Hawaii. Participants were randomly assigned into the intervention or control group with 159 and 161 in each group respectively. The randomized control trial (RCT) was conducted from May 2014 to December 31, 2015 with rolling enrollment from May 2014 to January 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Financial Incentives', 'description': "Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.\n\nFinancial Incentives: This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle."}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '10.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Heart Disease', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Smoking or Tobacco Dependence', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2014-04-15', 'resultsFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-31', 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in HbA1c From Baseline to the End of Intervention (December 2015)', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)'}, {'measure': 'Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)'}, {'measure': 'Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)'}, {'measure': 'Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)'}, {'measure': 'Changes in Triglycerides From Baseline to the End of Intervention (December 2015)', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)'}, {'measure': 'Changes in LDL From Baseline to the End of Intervention (December 2015)', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)'}, {'measure': 'Changes in HDL From Baseline to the End of Intervention (December 2015)', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)'}], 'secondaryOutcomes': [{'measure': 'Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers', 'timeFrame': 'Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention)', 'description': 'Changes of total cost expenditures including emergency room use and hospitalizations in the intervention and control groups before and during intervention.'}, {'measure': 'Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': 'SDSCA is a validated, self-reported measure assessing the average # of days the recommended diabetes self-care activities are performed over the past 7 days in the areas of general diet, specific diet, exercise, blood-glucose testing, and foot care at baseline, mid, and end of intervention. Possible scores range from 0 to 7 days. Change = (End of Intervention Score - Baseline Score)'}, {'measure': 'Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey', 'timeFrame': 'Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment', 'description': "The SF-36v2 is validated, self reported short-form health survey used to assess changes over time in the well-being of participants. It consists of 2 component summary measures that further summarize 8 health domain scales. The Physical Component Summary (PCS) measure is derived from domain scales of Physical Functioning (10 items), Role-Physical (4 items), Bodily Pain (2 items), and General Health (5 items). Scores of component summary measures and health domain scales range from 0 to 100 with higher scores indicating better outcomes. Norm-based scoring was used so that scores for each health domain scale and component summary measure have a mean of 50 and standard deviation of 10 based on the 2009 U.S. general population. The SF-36v2 was used to assess participants' health and wellbeing at baseline, mid, and endpoint of intervention. Change = (Midpoint Score - Baseline Score)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incentives,', 'Diabetes,', 'Medicaid,', 'Health behavior,', 'Cost effectiveness'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Organisation for Economic Co-Operation and Development (OECD), "Health Status: Life Expectancy at Birth, in Health at a Glance 2013: available at http://www.oecd.org/els/health-systems/Health-at-a-Glance-2013.pdf.'}, {'type': 'BACKGROUND', 'citation': 'Office of Minority Health 2010. Diabetes Data/Statistics. Retrieved from http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=3&lvlid=62'}, {'pmid': '19102784', 'type': 'BACKGROUND', 'citation': 'Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.'}, {'pmid': '24139781', 'type': 'BACKGROUND', 'citation': 'Mitchell MS, Goodman JM, Alter DA, John LK, Oh PI, Pakosh MT, Faulkner GE. Financial incentives for exercise adherence in adults: systematic review and meta-analysis. Am J Prev Med. 2013 Nov;45(5):658-67. doi: 10.1016/j.amepre.2013.06.017.'}, {'pmid': '18646105', 'type': 'BACKGROUND', 'citation': 'Cahill K, Perera R. Competitions and incentives for smoking cessation. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004307. doi: 10.1002/14651858.CD004307.pub3.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this randomized controlled trial (RCT) study is to examine the extent that financial incentives when combined with diabetes evidence-based practices, improve self-management and biometric measures for adult diabetic Medicaid recipients with an HbA1c of ≥ 6.5 at enrollment. The study will also evaluate the cost-effectiveness of the program.\n\nSpecific Aims:\n\n1. Evaluate whether financial incentives for completing American Diabetes Association (ADA) recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve primary biometric outcomes.\n2. Evaluate whether financial incentives for completing ADA recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve diabetes patients' self-management as assessed by Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF36v2).\n3. Evaluate the extent to which financial incentives for healthy behaviors reduce the cost of health care utilization.", 'detailedDescription': 'Diabetes is the seventh leading cause of death in the United States (OECD 2013). It is also known that certain populations are at greater risk for diabetes. In Hawaii, diabetes disproportionally affects Native Hawaiians and Pacific Islanders as they are three times more likely to be diagnosed with diabetes. In addition, in 2010 the U.S. Department of Health and Human Services Office of Minority Health reported that Native Hawaiians/Pacific Islanders in Hawaii were 5.7 times as likely as Caucasians living in Hawaii to die from diabetes(Office of Minority Health, 2010).\n\nIn order to address the challenges that chronic diseases impose on individuals and the health care system the Centers for Medicare \\& Medicaid Services (CMS) is assessing the impact of incentivizing patients to increase self-care and disease management. Previous studies have demonstrated that monetary incentives have been associated with an improvement in behavioral outcomes, most notably when the incentive is received immediately following the targeted behavior (Volpp, K.G., et.al., 2008; Mitchell, M.S., et.al., 2013). Cahill et al. (2008) showed that economic incentives were tied to smoking cessation and led to a decrease in relapse within a year. Our study seeks to build on these findings and determine whether financial incentives may provide a way to improve diabetes self-management.\n\nData:\n\nElectronic data (Labs, Outcomes) - January 1st, 2013 through December 31, 2015 Electronic data (Claims) - January 1st, 2011 through December 31, 2015'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinically diagnosed with diabetes mellitus\n2. 18 years of age or older\n3. Medicaid recipient\n4. At recruitment has an HbA1c level of ≥ 6.5\n5. At recruitment is receiving care coordination at Kaiser Permanente Hawaii\n\nExclusion Criteria:\n\n1. Current pregnancy - gestational diabetes\n2. End-stage Renal Disease\n3. Does not speak English'}, 'identificationModule': {'nctId': 'NCT02123251', 'acronym': 'HI-PRAISE', 'briefTitle': 'Hawaii Patient Reward And Incentives to Support Empowerment', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'A Randomized Incentive-Based Diabetes Self-Management Study (Hawaii Patient Reward And Incentives to Support Empowerment Project)', 'orgStudyIdInfo': {'id': 'CDFA93.536 -CMS-MIPCD-HI'}, 'secondaryIdInfos': [{'id': '1B1CMS330884-01', 'type': 'OTHER_GRANT', 'domain': 'CMS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Financial Incentives Group', 'description': 'Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.', 'interventionNames': ['Behavioral: Financial Incentives']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.'}], 'interventions': [{'name': 'Financial Incentives', 'type': 'BEHAVIORAL', 'description': "This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle", 'armGroupLabels': ['Financial Incentives Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Ritabelle Fernandes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hawaii'}, {'name': 'Rebecca R. Ozaki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unversity of Hawaii - Center on Disability Studies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Medicare and Medicaid Services', 'class': 'FED'}, {'name': 'Hawaii Department of Human Services (DHS)', 'class': 'UNKNOWN'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'RTI International', 'class': 'OTHER'}, {'name': 'IMPAQ International, LLC.', 'class': 'INDUSTRY'}, {'name': 'Econometrica, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rebecca Rude Ozaki', 'investigatorAffiliation': 'University of Hawaii'}}}}