Peer support and mHealth intervention to promote diabetes self-management in a rural community in Tamil Nadu, India - a cluster randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
研究者
Sudharshini Subramaniam
Rural Womens Social Education Centre