Implementing HEARTS in Guatemala
- Conditions
- Diabetes Mellitus, Type 2HypertensionCardiovascular Diseases
- Interventions
- Other: Integrated Diabetes and Hypertension Primary Care ModelOther: Integrated Diabetes and Hypertension Primary Care Model - Providers
- Registration Number
- NCT06080451
- Lead Sponsor
- University of Michigan
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 866
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HEARTS implementation - Patients Integrated Diabetes and Hypertension Primary Care Model A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study. HEARTS implementation - Providers Integrated Diabetes and Hypertension Primary Care Model - Providers A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.
- Primary Outcome Measures
Name Time Method Proportion of patient participants with subsequent follow-up visit within 3 months 3 months Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.
Score on Acceptability of Intervention Measure (AIM) Questionnaire 6 months Acceptability will be assessed among patients 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.
Number of target health districts that met enrollment goals 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 Feasibility of Intervention Measure (FIM) Questionnaire 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.
- Secondary Outcome Measures
Name Time Method Diabetes treatment rate 6 months Number of patients receiving diabetes medication treatment per month
Mean systolic blood pressure 6 months Mean systolic blood pressure among patients with hypertension
Fidelity - access to medicines and diagnostics 6 months Proportion of primary health facilities that had monthly availability of Ministry of Health medications and diagnostics for diabetes and hypertension. Drugs include antihypertensive medications (hydrochlorothiazide, enalapril, losartan) and oral hypoglycemic agents (metformin and glimepiride). Diagnostics including blood pressure cuffs and monitors, glucometers, lancets, and glucose strips.
Fidelity - systems monitoring and feedback 6 months Proportion of quarterly reports viewed by health district administrators
Hypertension treatment rate 6 months Number of patients receiving hypertension medication treatment per month
Proportion achieving control of blood pressure 6 months Proportion achieving control of blood pressure (\<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.
Mean diastolic blood pressure 6 months Mean diastolic blood pressure among patients with hypertension
Fidelity - health worker training 6 months Proportion of health workers in each district attending all training sessions
Fidelity - chart audit 6 months Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits
Proportion of participants achieving glycemic control 6 months Proportion achieving glycemic control (fasting blood glucose \<115 mg/dl or random blood glucose \<160 mg/dl) among patients with diabetes
Fidelity - facility-based electronic monitoring tool 6 months Proportion of patient visits captured in DHIS2 each month compared to comprehensive records in the Ministry of Health's Health Management Information System
Usability 6 months Average score on the System Usability Scale questionnaire. Scores are on a scale of 10 (worst) to 50 (best).
Fidelity - team-based care and task sharing 6 months Proportion of primary health districts conducting at least one care coordination meeting
Sustainability 6 months Average score on a sustainability questionnaire. Questionnaire was created by combining select questions from the System Usability Scale and the Clinical Sustainability Assessment Tool. Scores are on a scale of 10 (worst) to 70 (best).
Adoption 6 months Number of participating health facilities who enrolled at least one patient with hypertension or diabetes
Trial Locations
- Locations (1)
Ministry of Health clinics
🇬🇹San Pablo, Sololá, Guatemala