Awareness Generation through Village Health Nurses as Advocates for Long-term Follow up of Women with Gestational Diabetes Mellitus (AVAL-GDM): A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Proportion of women with GDM who undergo postpartum follow up and continuum of care.
研究概览
简要总结
This is a cluster randomized controlled trial which compares the proportion of women with Gestational Diabetes Mellitus (GDM) who undergo postpartum follow up in both the intervention and the control arms. The intervention group consists of trained Village Health Nurses (VHNs) who receive access to the intervention toolkit and mHealth application to persuade women with GDM to come for postpartum follow up while VHNs in the control arm provide routine antenatal and postpartum care according to the existing government policies. It is hypothesized that VHNs sensitized on long term complications of GDM and the implications of postpartum care will be more successful in facilitating women with GDM to undergo periodic assessment of their glycemic status postpartum. In this study, the unit of intervention are the Village Health Nurses and the unit of outcome assessment are the women with Gestational Diabetes Mellitus.
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
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosis of GDM in the current pregnancy confirmed by a 2-hour, 75-gram Oral Glucose Tolerance Test (OGTT) with a cut-off of greater than or equal to 140 mg/dL.
- •Women with GDM at 28 weeks of gestation and beyond, OR those nearing delivery, OR those who have delivered and are within the 6-week postpartum period.
排除标准
- •Presence of any physical or mental disabilities.
- •Presence of any chronic severe illnesses that can hinder the adoption of self-management or behaviour change practices advocated by our study.
结局指标
主要结局
Proportion of women with GDM who undergo postpartum follow up and continuum of care.
时间窗: 6-12 weeks, 6 months, 1 year and 2 years
次要结局
- Feasibility, acceptability, scalability, and sustainability of the intervention(2 years)
- Health beliefs in terms of perceived susceptibility, severity, perceived barriers, facilitators and cues to action for postpartum continuum of care for women with GDM(6-12 weeks, 6 months, 1 year and 2 years)
- Knowledge and practices of the VHNs related to postpartum(continuum of care for women with GDM)
研究者
Dr T S Selvavinayagam
Directorate of Public Health and Preventive Medicine