Community-based HEARTS Intervention (Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Enrollment proportion
研究概览
简要总结
The goal of this pilot study is to assess the feasibility of health system change intervention with a focus on recruitment of patients with hypertension, initiation of antihypertensive medication, and retention of patients in care at the Community Clinics (CC) with a goal of finalizing the key features of a team- and community-based intervention in rural Bangladesh.
Patients with uncomplicated hypertension will be enrolled, their medical treatment will be provided from CC by a Community Health Care Provider (CHCP) according to the telemedicine-based instruction of Medical Officer from Upazila Health Complex (UHC) with provision of referral to UHC for an in-person evaluation. Participants will be followed up periodically and their medicine will be refilled accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients residing in the catchment area of the selected 4 Community Clinics under selected 2 Upazila Health Complexes (UHCs)
- •Aged 18 years and older
- •Raised BP during screening [Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg (based on an average of minimum two measurements)]
- •Not currently taking antihypertensive medications
- •Eligible for the HEARTS technical package, defined as not being treated for an acute illness or medical emergency and not having a terminal illness
排除标准
- •Patients with cardiovascular diseases, chronic kidney diseases (as evident by previous laboratory report of serum creatinine or urinary protein more than ++ on dipstick test prior to the enrollment), diabetes, or BP >180/110 mmHg (based on the mean of last two BP measurements) at screening or after 14 days of recommended lifestyle modification will be excluded and referred directly to UHC for further management
- •Pregnancy or intent to become pregnant
- •Patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or do not provide written informed consent
研究组 & 干预措施
Intervention
This is a single-arm pilot study and all participants will receive the intervention. Participants will be diagnosed and treated for hypertension at Community Clinic (CC) by a Community Health Care Provider (CHCP) under telemedicine supervision from a Medical Officer at the Upazila Health Complex (UHC).
干预措施: Telemedicine-based WHO HEARTS package (Other)
结局指标
主要结局
Enrollment proportion
时间窗: 6 months from enrollment
The proportion of eligible individuals with raised BP identified at the Community Clinic (CC) who were enrolled, defined as those started on meds within 6 months of diagnosis
Short-term, intermediate, and long-term retention in care
时间窗: 3 months from enrollment for short-term retention in care, 6 to 12 months for intermediate retention in care, and 12 to 18 months for long-term retention in care
The proportion of enrolled individuals with raised BP who had a follow-up visit within 3 months of enrollment (short-term retention in care), between 6 and 12 months (intermediate retention in care), and between 12 and 18 months (long-term retention in care)
次要结局
- Blood pressure control(3, 6, 12, and 18 months from enrollment)