Implementing HEARTS in Guatemala

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases

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: 964

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Acceptability of Intervention Measure (AIM) Questionnaire	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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Hypertension Treatment Rate	6 months	Number of patients receiving hypertension medication treatment in the 6th month of the study.
Diabetes Treatment Rate	6 months	Number of patients receiving diabetes medication treatment in the 6th month of the trial..
Proportion of Patient 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
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.
Adoption	6 months	Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.
Fidelity - Health Worker Training	6 months	Number of health workers in each district attending all training sessions
Fidelity - Team-based Care and Task Sharing	6 months	Proportion of primary health facilities conducting at least one care coordination meeting
Fidelity - Access to Medicines and Diagnostics	6 months	Months in which primary health facilities 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. Data is reported in "clinic-months", which is the sum number of months that each clinic reported monthly availability of medications and diagnostics (n=60 total clinic months(10 clinics x 6 months)).
Fidelity - Facility-based Electronic Monitoring Tool	6 months	Proportion of patient visits captured in DHIS2 during the study compared to comprehensive records in the Ministry of Health's Health Management Information System. Data was collected at the end of the 6th month study. Data is presented as percent of visits that were captured.
Usability	6 months	Average score on the System Usability Scale questionnaire. Scores have a range of 0 (worst) to 100 (best). Questionnaire was given to the provider arm only.
Sustainability	6 months	Mean score on a sustainability questionnaire. Questionnaire was created by combining 6 questions from the Program Sustainability Assessment Tool (PSAT) and Clinical Sustainability Assessment Tools (CSAT). Scores range from 1 (worst) to 7 (best). The data reported is the median of the mean scores for each of the health providers.
Mean Systolic Blood Pressure	6 months	Mean systolic blood pressure among patients with hypertension
Mean Diastolic Blood Pressure	6 Months	Mean diastolic blood pressure among patients with hypertension
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
Fidelity - Systems Monitoring and Feedback	6 months	Proportion of quarterly reports viewed by health district administrators