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Does forming patients with diabetes into peer support groups improve their adoption of life style changes and does mobile based messaging enhance this effect?

Peer support and mHealth intervention to promote diabetes self-management in a rural community in Tamil Nadu, India - a cluster randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064153
Enrollment
534
Registered
2024-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Peer Support and mHealth: A peer support group is a group of patients with diabetes belonging to the same gender, and preferably the same social strata in terms of class and caste. We w

Sponsors

Azim Premji University Health Research Funding Programme 2023
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult residents of the intervention and control clusters with a confirmed diagnosis of type 2 diabetes and one treatment either by life style modifications alone, by tablets or by insulin are eligible to participate in the study.

Exclusion criteria

Exclusion criteria: Patients with disabilities or disease conditions that greatly limit their independent diabetes self management behaviours such as severely disabling stroke, dementia, movement disorders, congestive heart failure, chronic kidney disease or cancer will be excluded from the study. Persons with mental disabilities or disabilities in communication (visual, auditory) who cannot actively participate in peer support intervention and consume the mHealth messages will also be excluded from the study. Though mobile phones with an android application are ubiquitous nowadays, only those members who themselves or through one of their immediate household members have access to an android mobile phone will be eligible to participate in the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be adoption of self management behaviours at the individual level. The Summary Diabetes Self Care Activities Scale (SDSCA) will be used to assess the levels of self management behaviours.Timepoint: This will be monitored closely once every 3 months during the intervention period to see the patterns of adoption of the self management behaviours in intervention and control clusters.

Secondary

MeasureTime frame
The secondary outcomes include, glycemic control as measured by glycosylated haemoglobin level every 6 months, weight as measured every 6 months and blood pressure as measured every 3 months. The level of diabetes related distress will be measured using the Diabetes Distress Scale (DDS) once every 3 months.(11) Health care related costs will also be measured among members of the intervention and control clusters and compared. The outcome measures will be done at the individual level.Timepoint: HbA1c, health care expenditure and weight every 6 months, Diabetes distress every 3 months

Countries

India

Contacts

Public ContactSudharshini Subramaniam

Rural Womens Social Education Centre

sudharshini.subramaniam90@gmail.com9791736334

Outcome results

None listed

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