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Measuring Mental Wellbeing and Resilience in Type 2 diabetes mellitus patients MERIT-2-DM

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. - MERIT-2 DM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095092
Enrollment
192
Registered
2025-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Diabetes care package given through peer-group. buddy pairing and individual arms.: The diabetes care package will be developed in coordination with stakeholders and primary health care

Sponsors

Mahatma Gandhi Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1)Mental well-being 2) ResilienceTimepoint: 1)Baseline and post 6 months of intervention. 2)Baseline and post 6 months of intervention.

Secondary

MeasureTime frame
Diabetes related quality of life will be assessed with Diabetes Quality of life Brief Clinical Inventory a 15 item inventory.Timepoint: Baseline data will be collected using the above mentioned questionnaires during the initial Implementation phase after taking informed consent. Endline assessment will be done in the Post implementation phase using the same scales as mentioned priorly.;Control of Diabetes measured through HbA1c levels from early morning blood sample under standardized quality-controlled procedures following aseptic precautions.Timepoint: Baseline value will be collected during the Implementation phase before starting the intervention. Endline values will be collected in post-implementation phase.;Factors determining acceptability and practice of Diabetic care package interventions will be analyzed using PARIHS(Promoting Action on Research Implementation in Health Services) framework.Timepoint: Post implementation phase.

Countries

India

Contacts

Public ContactSREERAM B

MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES

abhishekvraut@gmail.com9422518347

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026