A Multi-component Intervention to Reduce Gaps in Hypertension Care and Control in Medellin, Colombia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study.
研究概览
简要总结
This study evaluates the effectiveness of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income Communes of Medellin, Colombia, and assess the process and fidelity of the intervention's implementation.
详细描述
A multi-component intervention was designed based on international guidelines, a cross-sectional population survey results, and consultation with the community and institutional stakeholders. Three main components integrate activities related to (I) Health services redesign, (II) Clinical staff training (III) Patient and community engagement. The effectiveness of the intervention will be evaluated in a controlled before-after quasi-experimental study, with two deprived Communes of the city selected as intervention and control arms. Two representative population-based surveys of adults aged 35 years or older will be undertaken in the intervention and the control Communes two years apart, one before the intervention implementation and the other after. The surveys will include different adults. The main outcomes assessed will be the gaps in hypertension diagnosis, treatment, follow-up and control. Effectiveness will be evaluated with "difference in difference" measures. Generalized estimation equations models will be fitted considering the clustered nature of data and adjusting for potential confounding variables. The implementation process will be studied with mixed methods. Finally, implementation fidelity will be documented to assess to which degree the components of the intervention were implemented as intended.
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)
盲法说明
Participants are kept unaware of the intervention implementation and its assignment in one commune or another. Furthermore, participants will be randomly recruited in both communes.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •35 years or older
- •Permanent inhabitant of the selected Communes
- •Must be able to provide written informed consent
排除标准
- •Mental disability
- •Unable to answer the questionnaire
研究组 & 干预措施
Routine Care
The Commune 6 was selected as control area, where routine care will be delivered.
A multi-component intervention to improve hypertension care and control
The intervention will be implemented in Commune 2. It will integrate activities related to 1) Health services redesign, 2) Clinical staff training and 3) Patient and community engagement. The intervention activities will be implemented by health services staff with technical assistance from the investigation team.
干预措施: 3. Patient and Community Engagement (Other)
A multi-component intervention to improve hypertension care and control
The intervention will be implemented in Commune 2. It will integrate activities related to 1) Health services redesign, 2) Clinical staff training and 3) Patient and community engagement. The intervention activities will be implemented by health services staff with technical assistance from the investigation team.
干预措施: 1. Health Services Redesign (Other)
A multi-component intervention to improve hypertension care and control
The intervention will be implemented in Commune 2. It will integrate activities related to 1) Health services redesign, 2) Clinical staff training and 3) Patient and community engagement. The intervention activities will be implemented by health services staff with technical assistance from the investigation team.
干预措施: 2. Clinical Staff Training (Other)
结局指标
主要结局
Number of individuals self-reporting a previous diagnosis of hypertension and encountered with uncontrolled hypertension during the study.
时间窗: through the population survey completion, up to 2 months
Uncontrolled hypertension: an average blood pressure measurement higher than 140/90 mmHg for aware hypertensive patients between 35 and 59 years old or for diabetic patients regardless of age, and higher than 150/90 mmHg for aware hypertensive patients aged 60 years or older.
次要结局
- Number of individuals without a previous diagnosis but presenting hypertension during the study.(through the population survey completion, up to 2 months)
- Number of individuals self-reporting a previous diagnosis of hypertension who did not attend a follow-up consultation during the last year.(through the population survey completion, up to 2 months)
- Number of aware hypertensive individuals who received a prescription of antihypertensive medication but either do not take the drugs or are non-adherent.(through the population survey completion, up to 2 months)