Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-09 @ 6:43 PM
Study NCT ID:
NCT02994095
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2016-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010865', 'term': 'Pilot Projects'}], 'ancestors': [{'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2016-12-14', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PACIC score', 'timeFrame': 'Six months', 'description': 'Quality of Diabetes Care Received'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '28086870', 'type': 'DERIVED', 'citation': 'do Valle Nascimento TM, Resnicow K, Nery M, Brentani A, Kaselitz E, Agrawal P, Mand S, Heisler M. A pilot study of a Community Health Agent-led type 2 diabetes self-management program using Motivational Interviewing-based approaches in a public primary care center in Sao Paulo, Brazil. BMC Health Serv Res. 2017 Jan 13;17(1):32. doi: 10.1186/s12913-016-1968-3.'}]}, 'descriptionModule': {'briefSummary': 'This was a pilot study to assess the feasibility and acceptability of training Community Health Agents in Motivational Interviewing in real-life primary care centers.', 'detailedDescription': "Rates of noncommunicable diseases (NCDs) such as type 2 diabetes are escalating in low and middle-income countries such as Brazil. Scalable primary care-based interventions are needed to improve self-management and clinical outcomes of adults with diabetes. This pilot study examines the feasibility, acceptability, and outcomes of training community health agents (CHAs) in Motivational Interviewing (MI)-based counseling for patients with poorly controlled diabetes in a primary care center in São Paulo, Brazil.\n\nNineteen salaried CHAs participated in 32 hours of training in MI and behavioral action planning. With support from booster training sessions, they used these skills in their regular monthly home visits over a 6 month period with 57 diabetes patients with baseline HbA1cs \\> 7.0%. The primary outcome was patients' reports of the quality of diabetes care as measured by the Portuguese version of the Patient Assessment of Chronic Illness Care (PACIC) scale. Secondary outcomes included changes in patients' reported diabetes self-management behaviors and in A1c, blood pressure, cholesterol and triglycerides. CHAs' fidelity to and experiences with the intervention were also assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with T2 diabetes who received care at the primary care center\n* A1c\\>7.0% in prior six months\n\nExclusion Criteria:\n\n* Age\\> 75\n* being pregnant\n* having terminal health condition or other conditions that would impede participation such as dementia and mental illness'}, 'identificationModule': {'nctId': 'NCT02994095', 'briefTitle': 'A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program Using Motivational Interviewing-based Approaches in a Public Primary Care Center in São Paulo, Brazil', 'orgStudyIdInfo': {'id': 'HUM00073693'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single intervention arm', 'description': 'Trained CHAs in Motivational Interviewing in pilot study', 'interventionNames': ['Behavioral: Pilot Study']}], 'interventions': [{'name': 'Pilot Study', 'type': 'BEHAVIORAL', 'description': 'Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes', 'armGroupLabels': ['Single intervention arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michele Heisler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data set available on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mary Ellen Michele Heisler', 'investigatorAffiliation': 'University of Michigan'}}}}