| CTRI Number |
CTRI/2024/03/064153 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Does forming patients with diabetes into peer support groups improve their adoption of life style changes and does mobile based messaging enhance this effect? |
|
Scientific Title of Study
|
Peer support and mHealth intervention to promote diabetes self-management in a rural community in Tamil Nadu, India - a cluster randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudharshini Subramaniam |
| Designation |
Medical and Public Health Consultant |
| Affiliation |
Rural Womens Social Education Centre |
| Address |
Department of Medicine and Public Health
61, Karumarapakkam Village, Tirukazhukundram, Chengalpet 603109
Kancheepuram
TAMIL NADU
603109
India |
| Phone |
9791736334 |
| Fax |
|
| Email |
sudharshini.subramaniam90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudharshini Subramaniam |
| Designation |
Medical and Public Health Consultant |
| Affiliation |
Rural Womens Social Education Centre |
| Address |
Department of Medicine and Public Health,
61, Karumarapakkam Village, Tirukazhukundram, Chengalpet 603109
Kancheepuram
TAMIL NADU
603109
India |
| Phone |
9791736334 |
| Fax |
|
| Email |
sudharshini.subramaniam90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudharshini Subramaniam |
| Designation |
Medical and Public Health Consultant |
| Affiliation |
Rural Womens Social Education Centre |
| Address |
Department of Medicine and Public Health,
61, Karumarapakkam Village, Tirukazhukundram, Chengalpet 603109
Kancheepuram
TAMIL NADU
603109
India |
| Phone |
9791736334 |
| Fax |
|
| Email |
sudharshini.subramaniam90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Azim Premji University Health Research Funding Programme 2023 |
|
|
Primary Sponsor
|
| Name |
Azim Premji University Health Research Funding Programme 2023 |
| Address |
Azim Premji University,
Survey No 66, Burugunte Village,
Bikkanahalli Main Road,
Sarjapura, Bengaluru 562125 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balasubramanian Palanisamy |
Rural Womens Social Education Centre |
Department of Medicine and Public Health,
61, Karumarapakkam Village,
Tirukazhukundram,
Chengalpet 603109
Kancheepuram
TAMIL NADU |
9443120751
researchbalu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rural Womens Social Education Centre (RUWSEC) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
mHealth alone |
For the clusters assigned to control group the mHealth messages will be shared one message per month for 2 years. They will receive the pamphlets. They will also receive their routine diabetes care. |
| Intervention |
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 will also select a peer support group leader who is the most influential and articulate member of that group. We will conduct peer support group meetings and provide mHealth messaging in the intervention clusters. These peer support groups will meet once every month for the entire intervention period of 2 years. Each meeting will last from 60-90 minutes. The first 15-20 minutes will be spent in introduction and sharing of the educational material on one of the themes of diabetes self management. During this support intervention the participants will be encouraged to share their experiences of managing diabetes, the concerns they have regarding their diabetes, the doubts they have, and other members will be encouraged to provide support in various forms including physical, emotional, psychological and informational support. In addition, the peer support leader will also serve as the bridge between the persons with diabetes and the base hospital diabetes clinic to facilitate medical care. In addition to this, every month on a fixed day of the month, an audio message and a video message on any one self-management behavior will be shared through mobile phone to all the support group members. These audio and video content will be prepared, peer reviewed, pilot tested and revised based on these inputs before dissemination. They will also be provided printed pamphlets covering the same messages. The same content will also be discussed during the first 15 minutes of the peer support group meeting. There will be one behaviour discussed per month in the first year of the study. During the second year, the same messages will be reinforced. The patients in the peer support groups will receive the routine diabetes care that they receive from either the public health system, from private health facilities or from the voluntary health organization. The interventions are at the cluster level. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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 Outcome
|
| Outcome |
TimePoints |
| 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. |
HbA1c, health care expenditure and weight every 6 months, Diabetes distress every 3 months |
|
|
Target Sample Size
|
Total Sample Size="534"
Sample Size from India="534"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sudharshini.subramaniam90@gmail.com].
- For how long will this data be available start date provided 16-02-2026 and end date provided 16-02-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background: Type 2 diabetes is rapidly increasing in low and middle income countries due to fast changing life styles. In India the public health program for type 2 diabetes largely emphasizes on screening, diagnosis and treatment including medications. There is very little emphasis on promoting diabetes self management behaviours. We have designed this study with an aim to assess the effectiveness of a diabetes peer support intervention along with mHealth messaging in adoption and maintenance of diabetes self management behaviours among persons with type 2 diabetes living in a rural area in Tamil Nadu, India. Methods: We propose to conduct a cluster randomized controlled trial in 25 project villages of the voluntary health organization where this study is based in Tamil Nadu, India. A cluster is a group of 10-12 persons with type 2 diabetes living in these villages. A total of 48 clusters will be randomly assigned in a 1:1 ratio to an intervention arm comprising of peer support group formation and monthly meetings in addition to mHealth messaging on diabetes self management behaviours or a control arm receiving the mHealth messaging alone. The clusters will be followed up periodically over a 2 year period to study the primary outcome of adoption and maintenance of diabetes self management behaviours, and secondary outcomes of glycemic control, weight loss, blood pressure control, diabetes related distress and health care related costs. In addition, the experiences of the peer support group members, feasibility, scalability, sustainability and acceptability of the peer support groups will be studied using qualitative methods. Individual level analysis of the primary and secondary outcome variables will be done using generalized linear model with generalized estimating equations to estimate the model coefficients. Discussion: We expect to find a significant impact of the peer support intervention in addition to mHealth messaging on adoption and maintenance of diabetes self management behaviours. Based on our findings we will propose policy interventions to scale up diabetes peer support programs throughout the state as a component of the public health diabetes control program. |