SMARThealth Pregnancy: A Pilot Cluster Randomised Study to Assess Feasibility & Acceptability of a Complex Intervention Using Mobile Decision Support to Detect, Refer & Manage Pregnant Women at High Risk of Future Cardiometabolic Disorders in Rural India.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Background: Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention.
Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.
Study design: Cluster randomised pilot study of 4 primary care centres (PHCs) in two diverse areas of rural India.
Outcome: The primary objective of this pilot study is to address the feasibility of the SMARThealth Pregnancy intervention.
详细描述
Background: Cardiovascular disease (CVD) is the leading cause of death in women in India, and the prevalence of cardiometabolic disorders is rising. Women in rural India (where two-thirds of the population live), are particularly vulnerable due to limited knowledge and healthcare access. Pregnancy-related conditions including hypertensive disorders of pregnancy (HDPs) and gestational diabetes mellitus (GDM) carry independent risks for future cardiovascular disease in women. Early identification, referral and management of pregnant women at increased risk of future cardiometabolic disorders may offer opportunities for prevention. Innovative solutions are required to address the needs of rural women, particularly during the transitions between antenatal and postpartum care and adult health services.
Objective: To determine the feasibility and acceptability of the SMARThealth Pregnancy intervention to improve the detection, referral and management of pregnant women at high-risk of future cardiometabolic disorders in rural India.
Study design: This is a pilot study, using an un-blinded, parallel group, cluster randomised controlled study design.
Study Sites: Jhajjar District, Haryana and Guntur District, Andhra Pradesh, India.
Primary outcome: The primary objective of this pilot study is to address the uncertainties around feasibility: (i) how many PHCs accepted the invitation to participate in a trial; (ii) whether the intervention is feasible with respect to participant recruitment rates, (iii) retention of pregnant women in the trial to 6 weeks postpartum; (iv) acceptability and feasibility of outcomes measures (to measure the efficacy within a definitive trial); (v) fidelity to the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PHC serving population of greater than 30,000 people.
- •Administrative lead for PHC consents for the PHC to participate in the study.
排除标准
- •Administrative lead does not give consent for the PHC to participate in the study.
- •Pregnant women:
- •Inclusion Criteria:
- •Age above 18 years.
- •Participant is recruited between 28-36 weeks gestation.
- •Participant is willing and able to give informed consent for participation in the study AND is:
- •Living in the villages affiliated to the PHC included in the study.
- •Exclusion Criteria:
- •Pregnant women who are younger than 18 years and;
- •Pregnant women who are not recruited between 28-36 weeks' gestation
- •Pregnant women not living in villages affiliated to the study PHCs will be excluded from the study.
结局指标
主要结局
Recruitment rate
时间窗: 12 months
Number of eligible pregnant women successfully recruited to study in 12 months.
Number of home visits completed by Community Health Worker
时间窗: 12 months
Number of home visits completed by Community Health Worker using the SMARThealth Pregnancy mHealth platform in line with study protocol.
Retention rate
时间窗: 12 months
Number of eligible participants who remain in study for entire duration up to and including the 6 week postpartum visit.
次要结局
- Number of pregnant women diagnosed with a hypertensive disorder of pregnancy.(12 months)
- Mean postpartum haemoglobin(12 months)
- Postpartum follow-up of pregnant women with gestational diabetes(18 months)
- Mean postpartum Diastolic Blood Pressure(12 months)
- Number of pregnant women diagnosed with severe anaemia.(12 months)
- Number of pregnant women diagnosed with gestational diabetes.(12 months)
- Mean postpartum Systolic Blood Pressure(12 months)