Evaluation of the WHO HEARTS Hypertension Control Package in the Primary Care Clinics of Bangladesh: A Quasi-experimental Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,935
- 试验地点
- 17
- 主要终点
- Difference in differences of systolic blood pressure (SBP)
研究概览
简要总结
Hypertension became the leading risk factor of death globally as well as in Bangladesh. Uncontrolled hypertension is the key challenge for the success of a hypertension control programs. According to the last national STEPS Survey in Bangladesh, hypertension control rate is only 11%. World Health Organization promoted the HEARTS technical package for the hypertension control programs to improve the control scenario. National Heart Foundation of Bangladesh is implementing a hypertension control program in selected Upazilas (sub-districts) of Bangladesh in collaboration with Non-Communicable Disease Control (NCDC) Program of Directorate General of Health Services (DGHS) and Resolve to Save Lives, USA. Proposed quasi experimental study will be conducted in collaboration with NCDC of DGHS, Resolve to Save Lives, USA and Johns Hopkins University, Baltimore with an objective of to evaluate the impact of HEARTS package on the rate of hypertension control in primary health care centers in Bangladesh. In this study equal number of hypertensive adult patients will be recruited in Upazila Health Complexes of control and intervention groups with a hypothesis of, implementation of HEARTS technical package in primary health care centers can reduce the blood pressure significantly. After obtaining informed written consent, respondents' basic demographic information, history of antihypertensive medication intake and related comorbidities will be taken. Blood pressure measurements data will be recorded also. All of these data will be collected via a secured mobile application, Simple App. Collected data will be preserved in a secured cloud based database. After six months of enrolment, and end-line data will be collected at the community setup, preferably at the home of respondents, following standard techniques of BP measurement by experienced Field Research Assistants. During whole of the study procedure, every ethical right of the participants will be preserved with an utmost priority. De-identified data will be shared with the partner organizations for further scientific analysis. This study will generate robust evidence for use of HEARTS technical packages in low-and middle-income countries, like Bangladesh, especially at low-level health facilities and provide guidance for designing and implementation of other hypertension control programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •Aged 18 and above
- •Have a diagnosis of hypertension (inclusive of known prior diagnosis or a new diagnosis), with a baseline systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg
- •Eligible for the HEARTS technical package, i.e., are not pregnant, not being treated for an acute illness or medical emergency, and do not have a terminal illness.
排除标准
- •Previously diagnosed hypertensive patients with a controlled BP at the time of enrollment (systolic BP <140 mmHg and diastolic BP < 90 mmHg). Either BP is controlled using diet and lifestyle measures or BP is controlled on antihypertensive medications,
- •Cognitive impairment that would prevent comprehension of and responding to questions
- •Patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or are not able to give written informed consent.
结局指标
主要结局
Difference in differences of systolic blood pressure (SBP)
时间窗: Six months
defined as between- group difference in BP change at six months (BP change at six months calculated for each group as end-line minus baseline mean systolic BP)
次要结局
- Difference in differences of diastolic blood pressure (DBP)(Six months)
- Difference in differences of rate of hypertension control.(Six months)
- Rate of loss to follow up(Six months)
- Difference in time to BP control(Six months)
- Rate of loss to follow-up.(Six months)
- Difference in differences of rate of hypertension control (Measured in the clinic)(Six months)