Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-04 @ 8:07 AM
Study NCT ID:
NCT02460718
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-09', 'studyFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated hemoglobin (A1c)', 'timeFrame': 'Change in A1c in 12 months', 'description': 'fingerstick, point-of-care a1c test'}, {'measure': 'Blood pressure', 'timeFrame': 'Change in blood pressure measure in 12 months', 'description': 'Measured using digital automated blood pressure monitor'}, {'measure': 'LDL cholesterol', 'timeFrame': 'Change in LDL cholesterol in 12 month', 'description': 'measured using finger stick, spectrophotometer to measure LDL cholesterol'}, {'measure': 'diabetes self-care behaviors questionnaire', 'timeFrame': 'Change in diabetes self-care behaviors at 12 months', 'description': 'aspects of diabetes self-management such as taking medications as directed, self-report of exercise, and eating behaviors'}, {'measure': 'depressive symptoms', 'timeFrame': 'change in depressive symptoms at 12 months', 'description': 'self-report using Patient Health Questionnaire 8 (PHQ8)'}, {'measure': 'quality of life', 'timeFrame': 'Change in quality of life measures at 12 months', 'description': 'self-report using Short form-1 (SF1), and Euroquol (EQ-5D)'}, {'measure': 'patient activation', 'timeFrame': 'change in patient activation in 12 months', 'description': 'self-report using the 13 item Patient Activation Measure (PAM13)'}], 'secondaryOutcomes': [{'measure': 'body mass index', 'timeFrame': 'change in BMI in 12 months', 'description': 'weight measured using digital scale, height measured using stadiometer'}, {'measure': 'diabetes knowledge', 'timeFrame': 'change in diabetes knowledge in 12 months', 'description': 'assessed using the Spoken Knowledge in Low Literacy in Diabetes Scale'}, {'measure': 'trust in physicians', 'timeFrame': 'change in trust in physicians in 12 months', 'description': 'assessed using the Trust in Physicians Scale'}, {'measure': 'composite measure of healthcare utilization', 'timeFrame': 'Change in health care utilization in 12 months', 'description': 'self-report by participant, number of times utilized healthcare services'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'peer support', 'pragmatic clinical trial'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '30373734', 'type': 'DERIVED', 'citation': 'Cherrington AL, Khodneva Y, Richman JS, Andreae SJ, Gamboa C, Safford MM. Impact of Peer Support on Acute Care Visits and Hospitalizations for Individuals With Diabetes and Depressive Symptoms: A Cluster-Randomized Controlled Trial. Diabetes Care. 2018 Dec;41(12):2463-2470. doi: 10.2337/dc18-0550. Epub 2018 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an innovative peer coaching intervention plus brief education vs. brief education alone on diabetes outcomes.', 'detailedDescription': 'The purpose of this project was to provide robust evidence on the effectiveness of a peer support intervention in improving diabetes outcomes by conducting a group-randomized, controlled implementation trial of a volunteer peer support intervention.\n\nThe study had three specific aims:\n\nAim 1. In Phase I (months 0-8), to perform a qualitative needs assessment with peer advisors and health care providers to inform peer advisor roles and responsibilities (i.e., the intervention) and peer advisor recruitment strategies, curriculum and training; and patient recruitment plans.\n\nAim 2. Also in Phase I, to pilot our collaboratively developed intervention and, based on pilot test results, to recruit and train peer advisors for the intervention, and begin patient recruitment.\n\nAim 3. In Phase II (months 9-32), conduct the group randomized implementation trial and evaluate it using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 or older in age, diagnosed with diabetes, under the care of a doctor\n\nExclusion Criteria:\n\n* not community dwelling, less than 19 years old, pregnant, end-stage medical conditions with limited life expectancy, no access to telephone, does not speak english'}, 'identificationModule': {'nctId': 'NCT02460718', 'acronym': 'ENCOURAGE', 'briefTitle': 'ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama', 'orgStudyIdInfo': {'id': 'T0808270039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Participants received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit. Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight.'}, {'type': 'EXPERIMENTAL', 'label': 'Encourage study', 'description': 'Participants in the intervention arm were paired with a peer coach, interacting by telephone weekly for the first 8 weeks and then monthly for a total of 10 months.\n\nParticipants also received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit. Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight.', 'interventionNames': ['Behavioral: ENCOURAGE Study']}], 'interventions': [{'name': 'ENCOURAGE Study', 'type': 'BEHAVIORAL', 'description': 'This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.', 'armGroupLabels': ['Encourage study']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will stay at UAB'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Monika M. Safford', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}