Implementing HEARTS in Guatemala

Hypertension Clinical Trial

Official title:

Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06080451
• Other study ID #: HUM00234613
• Secondary ID: K23HL161271
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient participants

Inclusion criteria:

• Non-pregnant adults aged =18 years
• Diagnoses of type 2 diabetes or hypertension
• Present for routine care at participating MOH primary health facilities

Exclusion criteria:

• Confirmed or suspected type 1 diabetes
• Pregnant
• Are not managed at MOH health centers or health posts Provider/other participants

Inclusion criteria:

• Participation in delivering HEARTS or on the Technical Advisory Committee

Exclusion criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Other:
• Integrated Diabetes and Hypertension Primary Care Model
The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. Training health workers on diabetes and hypertension treatment protocols Team-based care and task sharing Strengthening access to medications and diagnostics Electronic medical record system and registry Systems monitoring and feedback of key indicators
• Integrated Diabetes and Hypertension Primary Care Model - Providers
The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. Training health workers on diabetes and hypertension treatment protocols Team-based care and task sharing Strengthening access to medications and diagnostics Electronic medical record system and registry Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.

Locations

Country	Name	City	State
Guatemala	Ministry of Health clinics	San Pablo	Sololá

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Institute of Nutrition of Central America and Panama, Ministry of Health of Guatemala, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Feasibility of Intervention Measure (FIM) Questionnaire	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.	6 months
Primary	Number of target health districts that met enrollment goals	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	6 months
Primary	Score on Acceptability of Intervention Measure (AIM) Questionnaire	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.	6 months
Primary	Proportion of patient participants with subsequent follow-up visit within 3 months	Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.	3 months
Secondary	Hypertension treatment rate	Number of patients receiving hypertension medication treatment per month	6 months
Secondary	Diabetes treatment rate	Number of patients receiving diabetes medication treatment per month	6 months
Secondary	Proportion of participants achieving glycemic control	Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes	6 months
Secondary	Proportion achieving control of blood pressure	Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.	6 months
Secondary	Mean systolic blood pressure	Mean systolic blood pressure among patients with hypertension	6 months
Secondary	Mean diastolic blood pressure	Mean diastolic blood pressure among patients with hypertension	6 months
Secondary	Adoption	Number of participating health facilities who enrolled at least one patient with hypertension or diabetes	6 months
Secondary	Fidelity - health worker training	Proportion of health workers in each district attending all training sessions	6 months
Secondary	Fidelity - chart audit	Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits	6 months
Secondary	Fidelity - team-based care and task sharing	Proportion of primary health districts conducting at least one care coordination meeting	6 months
Secondary	Fidelity - access to medicines and diagnostics	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.	6 months
Secondary	Fidelity - facility-based electronic monitoring tool	Proportion of patient visits captured in DHIS2 each month compared to comprehensive records in the Ministry of Health's Health Management Information System	6 months
Secondary	Fidelity - systems monitoring and feedback	Proportion of quarterly reports viewed by health district administrators	6 months
Secondary	Usability	Average score on the System Usability Scale questionnaire. Scores are on a scale of 10 (worst) to 50 (best).	6 months
Secondary	Sustainability	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).	6 months