Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 964
- 试验地点
- 2
- 主要终点
- Score on Feasibility of Intervention Measure (FIM) Questionnaire
研究概览
简要总结
The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.
详细描述
A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Score on Feasibility of Intervention Measure (FIM) Questionnaire
时间窗: 6 months
Feasibility will be assessed among Ministry of Health (MOH) participants through the four-item Feasibility of Intervention Measure (FIM) Questionnaire and semi-structured interviews. A Spanish-language version of the FIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.
Number of Target Health Districts That Met Enrollment Goals
时间窗: 6 months
This study will be working with two different health districts, one in the west and the other in the east. This measure is the number of districts that met enrollment goals for patients for patients with diabetes (at least 25) and also for patients with hypertension (at least 25). A given patient may have both diabetes and hypertension and thus count toward each benchmark
Score on Acceptability of Intervention Measure (AIM) Questionnaire
时间窗: 6 months
Acceptability will be assessed among providers through the four-item Acceptability Intervention Measure (AIM) Questionnaire and semi-structured interviews. A Spanish-language version of the AIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.
Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months
时间窗: 3 months
Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.
次要结局
- Hypertension Treatment Rate(6 months)
- Diabetes Treatment Rate(6 months)
- Proportion of Patient Participants Achieving Glycemic Control(6 months)
- Proportion Achieving Control of Blood Pressure(6 months)
- Adoption(6 months)
- Fidelity - Health Worker Training(6 months)
- Fidelity - Team-based Care and Task Sharing(6 months)
- Fidelity - Access to Medicines and Diagnostics(6 months)
- Fidelity - Facility-based Electronic Monitoring Tool(6 months)
- Usability(6 months)
- Sustainability(6 months)
- Mean Systolic Blood Pressure(6 months)
- Mean Diastolic Blood Pressure(6 Months)
- Fidelity - Chart Audit(6 months)
- Fidelity - Systems Monitoring and Feedback(6 months)
研究者
David Flood
Assistant Professor of Medicine
University of Michigan