Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06259318
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2024-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D057545', 'term': 'Social Stigma'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a Hybrid Type 2 Effectiveness-Implementation Trial of a pilot, 2-arm, parallel-group, quasi-randomized trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach', 'timeFrame': 'Week 0 - 5, Week 12', 'description': 'The absolute number, proportion, and representativeness of individuals who are willing to participate in the quasi-experimental study for Kanasina Gulabi.'}, {'measure': 'Glycemic Control', 'timeFrame': 'Week 0, Week 12', 'description': 'Percentage of measured hemoglobin A1c (HbA1c) that represents average blood sugar levels over the past 3 months, used to measure diabetes management and glycemic control.'}, {'measure': 'Diabetes Knowledge', 'timeFrame': 'Week 0, Week 5, Week 12', 'description': "Diabetes Knowledge Questionnaire (DKQ-24). 24 self-report items to assess overall diabetes knowledge. Responses are measured as true, false, or don't know. One composite score is calculated (range: 0 - 24); higher scores reflect better diabetes knowledge."}, {'measure': 'Diabetes Distress', 'timeFrame': 'Week 0, Week 5, Week 12', 'description': 'Type 2 Diabetes Distress Assessment System (T2-DDAS). 8 self-report items to assess diabetes-related emotional distress in adults with type 2 diabetes. Responses are endorsed on a 5-point scale and refer to the past month. One composite mean score is calculated (range: 0 - 5); higher scores reflect more diabetes distress.'}, {'measure': 'Diabetes-Related Stigma', 'timeFrame': 'Week 0, Week 5, Week 12', 'description': 'Type 2 Diabetes Stigma Assessment Scale (DSAS-2). 19 self-report items to assess perceived and experienced stigma for adults with type 2 diabetes. Responses are endorsed on a 5-point scale and refer to the past two weeks. One composite score is calculated (range: 19 - 95); higher scores reflect more experiences of stigma.'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Week 0, Week 5, Week 12', 'description': 'Patient Health Questionnaire (PHQ-9). 9 self-report items to screen for depression and assess degree of severity. Responses are endorsed on a 4-point scale and refer to the past two weeks. One composite score is calculated (range: 0 - 27); higher scores reflect more depressive symptoms.'}, {'measure': 'Optimism', 'timeFrame': 'Week 0, Week 5, Week 12', 'description': 'Revised Life Orientation Test (LOT-R). 10 self-report items to measure positive and negative expectations strongly linked to the future. Responses are endorsed on a 5-point scale. One composite score is calculated (range: 0 - 24); higher scores reflect higher dispositional optimism.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young Adult', 'India'], 'conditions': ['Type 2 Diabetes', 'Quality of Life', 'Depression', 'Stigma, Social', 'Behavior, Health']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a pilot peer support intervention, entitled "Kanasina Gulabi" (Translation "My Dream Rose" in Kannada), designed to improve quality of life and diabetes management among young adults living with type 2 diabetes. The intervention, delivered by non-specialist providers - trained young adult peer navigators who are also managing type 2 diabetes - is expected to improve physical and mental health outcomes among participants. The sample includes young adults aged 18-40 with a diagnosis of type 2 diabetes in Mysore district, South India. Participants were quasi-randomly allocated to the intervention or control group. With the support of their peer navigators, intervention participants will develop action plans to improve their physical and mental health outcomes. This study plans to assess the feasibility, acceptability, and preliminary effectiveness of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 - 40 years old\n* self-reported to have type 2 diabetes\n* living in Mysore district\n* able to speak English or Kannada\n* and able to access a cellular phone during the study period\n\nExclusion Criteria:\n\n* pregnant\n* living with a serious medical or psychological disorder that would impede study procedure'}, 'identificationModule': {'nctId': 'NCT06259318', 'briefTitle': 'Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India', 'orgStudyIdInfo': {'id': '2023-0247'}, 'secondaryIdInfos': [{'id': '2023-03-11-77', 'type': 'OTHER', 'domain': 'Public Health Research Institute of India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: Kanasina Gulabi']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Kanasina Gulabi', 'type': 'BEHAVIORAL', 'description': 'Kanasina Gulabi is a theory-driven, educational-behavioral intervention designed to improve the quality of life and diabetes management among young adults living with type 2 diabetes in Mysore district, South India. In this intervention, young adults with type 2 diabetes were matched to non-specialist peer navigators -- trained young adult peers who were also managing type 2 diabetes -- and developed action plans to improve their physical and mental health outcomes. Intervention components included group education, mindfulness activities, self care activity tracking, and phone follow-ups to address knowledge gaps and misinformation about type 2 diabetes, build self-efficacy for type 2 diabetes-related self care activities, and provide emotional support for diabetes management.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Public Health Research Institute of India', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}], 'overallOfficials': [{'name': 'Eve S Puffer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Sumedha Ariely, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Research Institute of India', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}