Assessing the Efficacy and Safety of Community Health Worker-led Hypertension Management Enabled by a Mobile Clinical Decision Support Application Compared to Physician Care: a Randomized, Controlled, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP)
研究概览
简要总结
This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. The target population is patients with hypertension in rural Guatemala. Study duration will be 12-24 months.
详细描述
The investigators have developed an innovative system of care utilizing CHWs equipped with a mobile application and supported and supervised remotely by physicians. This model of care is adapted from a CHW-led diabetes program enabled by a similar CDS application which the investigators implemented in the same communities in rural Guatemala where we will carry out this proposed study. This program safely led to significant improvements in glycemic control. The mobile application is built on the widely-used CommCare platform and provides clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care.
The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician.
The Secondary Objective is to evaluate the safety, acceptability to patients, and cost of CHW-led care compared to care provided directly by a physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Adults age 18 or greater with diagnosis of hypertension AND blood pressure (BP) greater than or equal to 140/90 OR currently taking antihypertensive medication.
- •Ability to provide informed consent
排除标准
- •Pregnancy
- •Severe comorbid condition(s) with life expectancy less than 1 year
研究组 & 干预措施
Community Health Worker Care
Multimodal health systems intervention: hypertension management by trained CHWs equipped with a mobile clinical decision support (CDS) application and remote supervision and support by physicians. CHWs will meet with patients each month and, with the assistance of the CDS application, follow physician-approved and evidence-based protocols to initiate and titrate antihypertensives and medications to reduce cardiovascular risk; identify potential complications of hypertension or problems with medications; and provide lifestyle counseling. For patients with comorbid hypertension and diabetes, CHWs will also manage glycemic therapy and assess for diabetes complications with the assistance of the application.
干预措施: CommCare with Mobile Clinical Decision Support (CDS) Application (Other)
Community Health Worker Care
Multimodal health systems intervention: hypertension management by trained CHWs equipped with a mobile clinical decision support (CDS) application and remote supervision and support by physicians. CHWs will meet with patients each month and, with the assistance of the CDS application, follow physician-approved and evidence-based protocols to initiate and titrate antihypertensives and medications to reduce cardiovascular risk; identify potential complications of hypertension or problems with medications; and provide lifestyle counseling. For patients with comorbid hypertension and diabetes, CHWs will also manage glycemic therapy and assess for diabetes complications with the assistance of the application.
干预措施: Remote Supervision by Physicians (Other)
Physician Care
干预措施: CommCare Application without CDS (Other)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP)
时间窗: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)
次要结局
- Change in Diabetes Control(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Triglycerides(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in 10 year CVD risk (per WHO risk prediction charts)(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in H-SCALE: Physical Exercise Score(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Proportion of Participants with SBP less than 140mmHg(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Proportion of Participants with SBP less than their personalized goal(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Weight(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Total Cholesterol(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in H-SCALE: Weight Management Score(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in global hypertension care satisfaction score(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in self-reported adherence(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Diastolic Blood Pressure (DBP)(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Hemoglobin A1c (HbA1c)(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in LDL Cholesterol(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Creatinine(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Estimated Glomerular Filtration Rate (eGFR)(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in H-SCALE: Smoking Exposure Score(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in selected items from the Patient Assessment of Chronic Illness Care (PACIC) survey(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in HDL Cholesterol(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in H-SCALE: Alcohol Intake Score(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in Hypertension Self-Care Activity Level Effects (H-SCALE): Medication Adherence Subscale Score(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in H-SCALE: Healthy Eating Plan Score(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Change in pill count adherence ratio (PCAR)(Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months))
- Proportion of lifestyle knowledge questions answered correctly(through study completion, an average of 12 months)