Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-01-26 @ 6:45 PM
Study NCT ID:
NCT02681718
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2016-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlling Hyperglycemia Among Minority Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Hemoglobin A1C (CHW vs. Control)', 'timeFrame': '6 months', 'description': 'To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.'}, {'measure': 'Difference in Hemoglobin A1C (Text Message vs. Control)', 'timeFrame': '6 months', 'description': 'To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.'}], 'secondaryOutcomes': [{'measure': 'Percentage change in diabetes knowledge test scores', 'timeFrame': '6 months', 'description': 'Michigan Diabetes and Research Center Knowledge test'}, {'measure': 'Mean change in diabetes self-efficacy scores', 'timeFrame': '6 months', 'description': 'Perceived competence in diabetes scale'}, {'measure': 'Mean change in diabetes distress scores', 'timeFrame': '6 months', 'description': 'Problem areas in diabetes (PAID-5) scale'}, {'measure': "Mean change in participants' beliefs about using insulin scores", 'timeFrame': '6 months', 'description': 'Insulin treatment appraisal (ITAS) scale'}, {'measure': 'Mean changes in diabetes self-care activities', 'timeFrame': '6 months', 'description': 'Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking'}, {'measure': 'Percentage of participants who visited a physician due to a diabetes related follow-up', 'timeFrame': '6 months', 'description': 'Self- reported'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['A1C≥9%', 'minorities', 'economically disadvantaged'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care. The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.', 'detailedDescription': 'The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes. Patients from a safety-net hospital will be randomized into three groups: 1) a control group, 2) an intervention providing diabetes self-care text messages, or 3) an intervention using community health workers to provide diabetes education and linkage to care. Secondary objectives include increasing diabetes knowledge, improving diabetes self-management, and increasing use of primary care (i.e., make one visit to the physician in 6 months) among the intervention participants. A cost-effectiveness analysis will determine the most appropriate way to reduce the burden of uncontrolled diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\*Hyperglycemia with A1C ≥9%\n\nExclusion Criteria:\n\n* Lives greater than 20 miles driving distance from Mount Sinai Hospital\n* Pregnant women with gestational diabetes\n* Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes\n* Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)\n* Unable to understand and give informed consent in either English or Spanish\n* Currently or previously participated in a diabetes research study\n* Family member currently enrolled in a diabetes research study\n* Previously received diabetes care related cell phone text messages\n* Unable to receive text messages 3-4 times per week\n* Living in a homeless shelter or temporary housing\n* Plans to travel outside of the United States for more than 3 months in next year'}, 'identificationModule': {'nctId': 'NCT02681718', 'acronym': 'CHAMP', 'briefTitle': 'Controlling Hyperglycemia Among Minority Population', 'organization': {'class': 'OTHER', 'fullName': 'Sinai Health System'}, 'officialTitle': 'Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities', 'orgStudyIdInfo': {'id': 'MSH15-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Health Worker education', 'description': 'During a six-month intervention period, the CHWs will conduct six home-based visitations and provide individualized diabetes education using an intensive diabetes lifestyle curriculum called Diabetes Learning Circle (DLC), developed and used by the Sinai Diabetes Education Program. At each visit, lasting for approximately one hour, the participants will be motivated to set SMART behavioral goals for diabetes self-management. At each visit after the initial visit, CHWs will follow-up with each participant to check their progress on their behavioral SMART goals. In addition, the CHWs will conduct intermittent phone calls (at least one monthly) and home visits as needed.', 'interventionNames': ['Behavioral: Community health worker education']}, {'type': 'EXPERIMENTAL', 'label': 'Cell phone text messaging', 'description': 'The participants in the text messaging group will receive weekly text messages through CareMessage. Each participant will receive 3-4 text messages per week for 6 months.', 'interventionNames': ['Behavioral: Cell phone text messaging']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "The participants in the control group will receive education as determined by the hospital's diabetes educator, dietitian, physician, or the participant's managed care provider. No additional education will be provided by the research team."}], 'interventions': [{'name': 'Community health worker education', 'type': 'BEHAVIORAL', 'description': 'Diabetes self-management education by community health workers', 'armGroupLabels': ['Community Health Worker education']}, {'name': 'Cell phone text messaging', 'type': 'BEHAVIORAL', 'description': 'Diabetes self-management education through cell phone text messaging', 'armGroupLabels': ['Cell phone text messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinai Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}