Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- University of Michigan
- Enrollment
- 964
- Locations
- 1
- Primary Endpoint
- Score on Feasibility of Intervention Measure (FIM) Questionnaire
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
David Flood
Assistant Professor of Medicine
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Score on Feasibility of Intervention Measure (FIM) Questionnaire
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 3 months
Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.
Secondary Outcomes
- 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)