Ministry of Health clinics
San Pablo La Laguna, Departamento de Sololá, Guatemala
NCT Number: NCT06080451
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
San Pablo La Laguna, Departamento de Sololá, Guatemala
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient participants
Inclusion criteria
Exclusion criteria
Provider/other participants
Inclusion criteria
Exclusion criteria
The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.
Other names: HEARTS
The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.
Health care providers will administer this intervention to patient participants and will report on their experience.
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.
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
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.
Time frame: 3 months
Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.
Time frame: 6 months
Number of patients receiving hypertension medication treatment in the 6th month of the study.
Time frame: 6 months
Number of patients receiving diabetes medication treatment in the 6th month of the trial..
Time frame: 6 months
Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes
Time frame: 6 months
Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.
Time frame: 6 months
Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.
Time frame: 6 months
Number of health workers in each district attending all training sessions
Time frame: 6 months
Proportion of primary health facilities conducting at least one care coordination meeting
Time frame: 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)).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Mean systolic blood pressure among patients with hypertension
Time frame: 6 Months
Mean diastolic blood pressure among patients with hypertension
Time frame: 6 months
Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits
Time frame: 6 months
Proportion of quarterly reports viewed by health district administrators
University of Michigan
Other
Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06186102
Arterial Occlusive Diseases, Arteriosclerosis
Aarhus, Jutland, Denmark
View Trial DetailsNCT05239572
Cardiovascular Diseases, Diabetes Mellitus
Hanoi, Vietnam
View Trial DetailsNCT02317003
Behavior, Cardiovascular Diseases
Angers, France
View Trial DetailsNCT00000620
Arterial Occlusive Diseases, Arteriosclerosis
Minneapolis, Minnesota, United States
View Trial Details