Trial Outcomes & Findings for Implementing HEARTS in Guatemala (NCT NCT06080451)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

964 participants

Primary outcome timeframe

6 months

Results posted on

2025-06-19

Participant Flow

Providers not considered Enrolled

Participant milestones

Participant milestones
Measure	HEARTS Implementation - Patients 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 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.
Overall Study STARTED	964	40
Overall Study Completed Provider Survey (Not Applicable to Patient Arm)	0	20
Overall Study COMPLETED	964	20
Overall Study NOT COMPLETED	0	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data was only collected for the patient arm and not for the provider arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HEARTS Implementation - Patients n=964 Participants 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. 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. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators	HEARTS Implementation - Providers n=20 Participants 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. 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. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.	Total n=984 Participants Total of all reporting groups
Age, Continuous	55.2 years n=964 Participants • Age data was only collected for the patient arm and not for the provider arm.	—	55.2 years n=964 Participants • Age data was only collected for the patient arm and not for the provider arm.
Sex: Female, Male Female	760 Participants n=964 Participants • Sex data was only collected for the patient arm and not for the provider arm.	—	760 Participants n=964 Participants • Sex data was only collected for the patient arm and not for the provider arm.
Sex: Female, Male Male	204 Participants n=964 Participants • Sex data was only collected for the patient arm and not for the provider arm.	—	204 Participants n=964 Participants • Sex data was only collected for the patient arm and not for the provider arm.
Ethnicity (NIH/OMB) Hispanic or Latino	474 Participants n=964 Participants • Ethnicity data was only collected for the patient arm and not for the provider arm.	—	474 Participants n=964 Participants • Ethnicity data was only collected for the patient arm and not for the provider arm.
Ethnicity (NIH/OMB) Not Hispanic or Latino	486 Participants n=964 Participants • Ethnicity data was only collected for the patient arm and not for the provider arm.	—	486 Participants n=964 Participants • Ethnicity data was only collected for the patient arm and not for the provider arm.
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=964 Participants • Ethnicity data was only collected for the patient arm and not for the provider arm.	—	4 Participants n=964 Participants • Ethnicity data was only collected for the patient arm and not for the provider arm.
Region of Enrollment Guatemala	964 participants n=964 Participants	20 participants n=20 Participants	984 participants n=984 Participants

PRIMARY outcome

Timeframe: 6 months

Population: This outcome measure only applies to the Providers group. No data was collected for the Patients group. Only 20 providers responded to this survey.

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.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=20 Participants 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.	HEARTS Implementation - 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.
Score on Feasibility of Intervention Measure (FIM) Questionnaire	5.0 score on a scale Interval 5.0 to 5.0	—

PRIMARY outcome

Timeframe: 6 months

Population: This outcome measure only applies to the Patients group. No data was collected for the Providers group.

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

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=2 Districts 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.	HEARTS Implementation - 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.
Number of Target Health Districts That Met Enrollment Goals	2 Districts	—

PRIMARY outcome

Timeframe: 6 months

Population: Only 20 providers responded to this survey. This measure only applies to the provider arm.

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.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=20 Participants 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.	HEARTS Implementation - 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.
Score on Acceptability of Intervention Measure (AIM) Questionnaire	5.0 score on a scale Interval 4.8 to 5.0	—

PRIMARY outcome

Timeframe: 3 months

Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=964 Participants 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.	HEARTS Implementation - 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.
Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months	36 percentage of patients	—

SECONDARY outcome

Timeframe: 6 months

Number of patients receiving hypertension medication treatment in the 6th month of the study.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=964 Participants 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.	HEARTS Implementation - 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.
Hypertension Treatment Rate	197 Participants	—

SECONDARY outcome

Timeframe: 6 months

Number of patients receiving diabetes medication treatment in the 6th month of the trial..

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=964 Participants 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.	HEARTS Implementation - 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.
Diabetes Treatment Rate	108 Participants	—

SECONDARY outcome

Timeframe: 6 months

Population: Monitoring system only captured data from 39 participants and failed to capture data for other participants

Proportion achieving glycemic control (fasting blood glucose \<115 mg/dl or random blood glucose \<160 mg/dl) among patients with diabetes

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=39 Participants 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.	HEARTS Implementation - 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.
Proportion of Patient Participants Achieving Glycemic Control	41 percent	—

SECONDARY outcome

Timeframe: 6 months

Population: The monitoring system was incompletely utilized and only captured this data for 83 participants

Proportion achieving control of blood pressure (\<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=83 Participants 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.	HEARTS Implementation - 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.
Proportion Achieving Control of Blood Pressure	50.6 percent	—

SECONDARY outcome

Timeframe: 6 months

Population: One of the eleven initially planned health facilities declined to participate in the study.

Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=10 Clinics 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.	HEARTS Implementation - 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.
Adoption	10 Clinics	—

SECONDARY outcome

Timeframe: 6 months

Number of health workers in each district attending all training sessions

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=40 Participants 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.	HEARTS Implementation - 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.
Fidelity - Health Worker Training District 1	20 Participants	—
Fidelity - Health Worker Training District 2	20 Participants	—

SECONDARY outcome

Timeframe: 6 months

Population: This group is of Clinics, not of participants. One of the eleven initially planned facilities declined to participate in this study.

Proportion of primary health facilities conducting at least one care coordination meeting

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=10 Clinics 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.	HEARTS Implementation - 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.
Fidelity - Team-based Care and Task Sharing	10 Clinics	—

SECONDARY outcome

Timeframe: 6 months

Population: One of the eleven initially planned facilities declined to participate in this study.

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)).

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=10 Clinics 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.	HEARTS Implementation - 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.
Fidelity - Access to Medicines and Diagnostics	49 clinic-months	—

SECONDARY outcome

Timeframe: 6 months

Population: Number of patient visits

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.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=1374 Visits 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.	HEARTS Implementation - 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.
Fidelity - Facility-based Electronic Monitoring Tool	7.6 percentage of visits	—

SECONDARY outcome

Timeframe: 6 months

Population: Questionnaire was given to the provider arm only. 20 of the 40 providers responded to this survey.

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.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=20 Participants 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.	HEARTS Implementation - 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.
Usability	67.7 units on a scale Standard Deviation 23.5	—

SECONDARY outcome

Timeframe: 6 months

Population: 20 of the 40 provider participants responded to this survey.

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.

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=20 Participants 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.	HEARTS Implementation - 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.
Sustainability	5.3 units on a scale Interval 4.8 to 5.9	—

SECONDARY outcome

Timeframe: 6 months

Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and data was only collected for 72 patients. This outcome measure did not apply to the provider's arm.

Mean systolic blood pressure among patients with hypertension

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=72 Participants 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.	HEARTS Implementation - 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.
Mean Systolic Blood Pressure	141.7 mmHg Standard Deviation 18.5	—

SECONDARY outcome

Timeframe: 6 Months

Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and data was only collected for 71 patients. This outcome measure did not apply to the provider's arm. While Systolic pressure was recorded for 72 participants, diastolic pressure was not recorded from one of these participants due to an unknown error at the clinic.

Mean diastolic blood pressure among patients with hypertension

Outcome measures

Outcome measures
Measure	HEARTS Implementation - Providers n=71 Participants 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.	HEARTS Implementation - 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.
Mean Diastolic Blood Pressure	81.5 mmHg Standard Deviation 11.2	—

SECONDARY outcome

Timeframe: 6 months

Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and no data was collected due to physicians' declination to use the software. This measure only applied to the patients arm.

Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and no data was collected due to physicians' declination to use the software.

Proportion of quarterly reports viewed by health district administrators

Outcome measures

Outcome data not reported

Adverse Events

HEARTS Implementation - Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HEARTS Implementation - Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Flood

University of Michigan

Phone: 734-647-2892

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place