Effectiveness of peer-group, buddy-paired, and individual diabetes care models for promoting Mental well-being and Resilience in adults with Type 2 Diabetes mellitus from rural central India (MERIT-2 DM): a three-arm parallel cluster randomized controlled trial.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- 1)Mental well-being
Overview
Brief Summary
The MERIT-2 DM study is a cluster-randomized controlled trial aimed at evaluating the effectiveness of three models of diabetes care: peer-group support, buddy pairing, and individual care-in improving mental well-being, resilience, quality of life, and diabetes control among adults with Type 2 Diabetes Mellitus (T2DM) and acceptability and practice such models in rural central India. With the rising diabetes in India, particularly in underserved areas, and the psychological impact of the disease, this study integrates psychosocial interventions into diabetes management.
A total of 192 participants from 24 rural clusters (villages) across three Ayushman Arogya Mandir Primary Health Centers will be enrolled. Participants will be randomized into one of three arms: (1) peer-group support, (2) buddy-pairing, or (3) individual standard care. Over a 6-month intervention period, trained health workers will deliver structured diabetes care sessions focusing on mental well-being, lifestyle changes, interpersonal skills, and self-management. These sessions will be followed by another 6 months of follow-up and evaluation.
Primary outcomes include improvements in mental well-being (measured using WHO-5) and resilience (measured by the Brief Resilience Scale). Secondary outcomes include changes in diabetes-related quality of life, HbA1c levels, and acceptability of the intervention models. Both quantitative (via validated scales and blood tests) and qualitative methods (via interviews and thematic analysis) will be used to assess impact.
As the study is trying to assess the effectiveness of the different methods of diabetes care delivery such as peer groups, buddy pairs, and individual level each arm will serve as both intervention and control arm and hence blinding will not be possible for this study.
This study addresses a critical gap in India’s NP-NCD program, which currently lacks mental health integration in diabetes care. If successful, the MERIT-2 DM model could serve as a cost-effective, scalable, and culturally relevant strategy to improve psychosocial and clinical outcomes among rural diabetic populations, potentially informing national policy and strengthening community-based chronic disease care. Approval from ethics committee was obtained and currently submission of approved documents and title and synopsis of the thesis is under process to the the concerned university. Once the university shows no objection to proceed I the principal investigator will begin with the study in a phased manner, such as preparatory phase, implementation phase and post implementation phase.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •INCLUSION CRITERIA FOR CLUSTERS Villages under PHCs with no vacancy in primary health care staff namely CHO NCD ANM and ASHA under NP NCD program with good network connectivity will be selected A radius of 30 km is being kept for including villages under the field practice area.
- •INCLUSION CRITERIA FOR INDIVIDUALS/PARTICIPANTS Providing written informed consent Know diabetic resident of the same village for over 6 months Willing to comply with the intervention activities and study procedures Willing to stay in study area for the entire study duration.
Exclusion Criteria
- •FOR CLUSTERS NP NCD staff under the concerned health and wellness centre not consenting to support the study Villages lacking adequate EXCLUSION CRITERIA FOR INDIVIDUALS/PARTICIPANTS Patients under 18 years of age Those who will be categorized under severe score that is score of 9 to 13 during the initial screening using PHQ 4 questionnaire Patients with complication in chronic conditions such as cardiovascular issues chronic kidney disease stroke and so on Patients who are already on psychiatric treatment Pregnant and Lactating females.
Outcomes
Primary Outcomes
1)Mental well-being
Time Frame: 1)Baseline and post 6 months of intervention. | 2)Baseline and post 6 months of intervention.
2) Resilience
Time Frame: 1)Baseline and post 6 months of intervention. | 2)Baseline and post 6 months of intervention.
Secondary Outcomes
- Diabetes related quality of life will be assessed with "Diabetes Quality of life Brief Clinical Inventory a 15 item inventory.(Baseline data will be collected using the above mentioned questionnaires during the initial Implementation phase after taking informed consent.)
- Control of Diabetes measured through HbA1c levels from early morning blood sample under standardized quality-controlled procedures following aseptic precautions.(Baseline value will be collected during the Implementation phase before starting the intervention.)
- Factors determining acceptability and practice of Diabetic care package interventions will be analyzed using PARIHS(Promoting Action on Research Implementation in Health Services) framework.(Post implementation phase.)
Investigators
SREERAM B
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES