CONNECT-HTN Trial - Coaching and Navigation by CHWs Through Telehealth for High-risk Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,620
- 试验地点
- 6
- 主要终点
- Rate of Major Adverse Cardiac Events (MACE)
研究概览
简要总结
The investigators propose an intervention that leverages the success of Community Healthcare Workers (CHWs) and telehealth to connect patients with severe hypertension from Emergency Department (ED) to primary care resources and to coach them to adopt evidence-based, practical lifestyle solutions relevant to urban living. The investigators have proposed this intervention as "Coaching and Navigation by Community Health Workers (CHWs) through Telehealth for High-risk Hypertension: CONNECT-HTN intervention. The investigators hypothesize that participants receiving the CONNECT-HTN intervention will have a lower likelihood of experiencing a major cardiac event compared with those referred to clinic-based care.
详细描述
This study is a randomized controlled trial evaluating whether telehealth-based coaching and navigation delivered by community health workers can improve cardiovascular outcomes among adults presenting to Emergency Departments (EDs) in Karachi with severe hypertension. Participants are randomly assigned either to receive a standard referral to primary care or to receive structured telephone-based navigation and behavioral coaching from trained community health workers.
The primary objective is to determine whether the CONNECT-HTN intervention reduces the rate of major adverse cardiovascular events (MACE) over the follow-up period. Secondary objectives include evaluating changes in blood pressure over time and examining patterns of follow-up in outpatient primary care. Outcome assessments are conducted by an independent team blinded to treatment assignment.
The study aims to provide evidence on the effectiveness of a scalable telehealth-supported community health worker model for improving long-term outcomes among patients with severe hypertension in low-resource urban settings.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Randomized Controlled Trial
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
- •Eligible patients
- •Must be over the age of 18 years
- •Have an ED triage SBP ≥ 180 and/or DBP ≥ 110, with a repeat similar reading ≥30 minutes after triage
- •May have received treatment for elevated BP, but must have no evidence of end-organ damage (defined as dialysis dependence, acute stroke, acute coronary syndrome, acute kidney injury, or papilledema)
- •Have a functional status of either fully active (independent in daily activities) or mildly restricted but ambulatory and able to work (washing, toileting, dressing, feeding, mobility).
- •May be admitted for deranged BP only with no complications, or may be stable for discharge per treating emergency physician
- •Include referrals from the clinic to the ED with SBP/DBP values in the inclusion range
- •Can provide informed consent. Intervention is accessible to individuals of all literacy levels
- •Can receive phone calls and in-person visits. Smartphone ownership not required (intervention compatible with analog phones)
排除标准
- •Given that hypertension is defined and treated differently, we will exclude
- •pregnant patients
- •terminally ill patients, as well as
- •those requiring admission to the hospital due to severe complications (other than deranged BP).
研究组 & 干预措施
Referral arm
In the referral arm, patients with hypertension will receive a digital BP monitor (an Omron device), a brief teaching session on its proper use, and an emergency medical services number for any medical concerns. A small outcomes team will visit their household within 3 months of their discharge from the Emergency Department (ED) to review their readings and ask a few more questions about their health. This outcome team will visit every 6 months for a total of five home visits to monitor their health.
干预措施: Standard ED management (Other)
T-CHW arm
In the T-CHW arm, patients with hypertension will receive a digital BP monitor (an Omron device) and a brief teaching session on its proper use. They will also be connected with a Community Healthcare Worker (CHW) via a telephone number. The CHW will call them to ask about their health and counsel them on diet and exercise to support good blood pressure control. The CHW will call them every month at a mutually convenient time for up to 36 months.
A small outcomes team will visit their household within 3 months of their discharge from the ED to review their readings and ask a few more questions about their health. This outcome team will visit every 6 months for a total of five home visits to monitor their health.
干预措施: CONNECT-HTN (Behavioral)
结局指标
主要结局
Rate of Major Adverse Cardiac Events (MACE)
时间窗: Up to 36 months (during the outcome collection period)
Major Adverse Cardiovascular Events (MACE) is a composite outcome including heart attack (myocardial infarction), stroke, heart failure, and cardiovascular death. The primary outcome will be assessed by comparing the cumulative incidence of MACE events between participants randomized to the CONNECT-HTN intervention arm and those randomized to referral to clinic-based care. MACE events will be identified through participant interviews, hospital record review, death certificates during the outcome collection team visit and verbal autopsy when required, and adjudicated using standardized criteria.
次要结局
- Blood Pressure (SBP/DBP) Over Time(Every 6 months during follow-up (up to 36 months))
- Outpatient Primary Care Follow-up(Up to 36 months)
- Medication Adherence (MMAS-8 Score)(Every 6 months during the 36-month follow-up period.)