Behavioural Science Strategies to Increase Hypertension Diagnosis and Treatment BETTER HEART study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,700
- 试验地点
- 1
- 主要终点
- The primary outcome will be assessed at 3 months. The primary outcome will be the receipt of confirmatory blood pressure measurement from a physician at a PHC. This is a binary variable that will be assessed by study staff members based at each PHC. As noted above, the staff will be tasked with recording whether study participants attended the PHC in the three months after enrollment.
研究概览
简要总结
Elevated blood pressure is a leading risk factor for mortality worldwide, yet much of this mortality is preventable through early diagnosis and sustained use of available treatments. Low and middle-income countries face a disproportionate burden of hypertension, as they account for over 80% of people living with hypertension. Increasing the diagnosis, treatment, and control of hypertension is therefore essential for improving health outcomes. In the world’s largest country, India, hypertension prevalence among adults remains high and a vast majority of those with hypertension are undiagnosed or not receiving care. This project will utilize insights from behavioral science to address important barriers to clinic-based confirmatory blood pressure measurement and linkage to hypertension care. The project will test behavioral strategies that help individuals form correct beliefs about the need for treatment and that offset the costs associated with care-seeking. Building on our expertise in behavioral science research and our extensive prior work in India, the Behavioral Science Strategies to Increase Hypertension Diagnosis and Treatment (BETTER HEART) study will use a randomized controlled trial with a factorial design to determine the effectiveness of two promising and scalable behavioral science strategies to increase uptake of clinic-based hypertension care in Andhra Pradesh, India.
Specific aims of the project are as follows. Aim 1: Adapt and refine promising user-centered strategies for promoting clinic-based confirmatory blood pressure measurement for the Indian context using participatory prototyping and survey experiments. Aim 2: Determine the effectiveness of enhanced hypertension counseling and financial incentives for increasing clinic-based confirmatory blood pressure measurement. Aim 3: Conduct a qualitative evaluation to contextualize the effectiveness data and inform future implementation of strategies on a larger scale. Findings from this study will strengthen our understanding of how to adapt behavioral science strategies to local settings and advance the scientific evidence on behavioral strategies to address the growing burden of hypertension in India and other LMICs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •For the randomized trial, we will enroll individuals who meet the following inclusion criteria: Age ≥30 years, elevated BP (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) measured at home by trained research assistants, and no prior physician diagnosis of hypertension (self-reported).
- •We have chosen to focus on those aged ≥30 years as this is the official age cutoff used for home-based and opportunistic hypertension screening in India.
排除标准
- •We will exclude individuals who meet the following criteria: Self-reported prior history of stroke or myocardial infarction, alcohol abuse, drug abuse, self-reported hyperthyroidism, and self-reported kidney disease.
- •There will be no exclusions based on sex or gender.
- •Since hypertension may affect any person regardless of their sex/gender, it is important that study participants are recruited irrespective of their sex or gender.
结局指标
主要结局
The primary outcome will be assessed at 3 months. The primary outcome will be the receipt of confirmatory blood pressure measurement from a physician at a PHC. This is a binary variable that will be assessed by study staff members based at each PHC. As noted above, the staff will be tasked with recording whether study participants attended the PHC in the three months after enrollment.
时间窗: baseline;12 weeks
次要结局
- The secondary outcome will be assessed at 6 months. About 6 months from enrolment, the study team will schedule an appointment with participants to ask them some additional questions & measure their blood pressure again. The secondary outcome is an indicator of whether the participant received treatment & had controlled BP (140/90 mmHg) at 6 months. This will be assessed during the 6-month follow-up visit.(baseline, 24 weeks)
研究者
Dr Nikhil Tandon
All India Institute of Medical Sciences