An interventional study of HF follow up care and HF Standard of Care (SOC) in Heart Failure, sponsored by Boston Medical Center. Completed at 1 site in Haiti. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Health services research
Evidence-based interventions to improve linkage and outcomes for heart failure (HF) patients requires input from stakeholders: patients, community health workers (CHWs), healthcare staff, and health system administrators.
In this research the investigators will assess a CHW intervention designed to improve linkage to care for HF patients. This intervention was systematically adapted for use in rural Haiti in a prior study using the Assessment, Decisions, Administration, Production, Topical Experts, Integration, Training staff, Testing (ADAPT-ITT) framework. The ADAPT-ITT framework provides 8 sequential phases to adapt interventions and programs to new target audiences. It has been applied successfully to the adaptation of several interventions for HIV among under-resourced communities leading to randomized clinical trials. With the first 6 steps of the ADAPT-ITT framework completed in a prior study, this protocol outlines the training and testing of the adapted CHW intervention.
In addition to assessing the feasibility, appropriateness, and acceptability of the adapted intervention through participants' feedback, the investigators will assess its efficacy in improving HF outcomes. The proposed intervention is targeted at both the patient domain - through improved peer support - and health system domain - by improving health system navigation.
The investigators will train six CHWs in a linkage-to-care intervention. The clinical trial will involve testing of the intervention on 30 HF patients. In a prior study, the ADAPT-ITT framework was used to adapt a CHW-based intervention for post-discharge HF patients in Haiti. This study represents the last two phases of the ADAPT-ITT framework: Training and Testing.
The study population will include adult HF patients (> 18 years of age), hospitalized for more than 48 hours, discharged from Hôpital-Universitaire de Mirebalais (HUM), without a prior clinic visit, living in Mirebalais Commune. Patients will be recruited for study participation shortly before discharge. A comparison group of 30 HF patients will be recruited and will not participate in the follow up care intervention. Those patients will be retrospectively identified from the medical record. The comparison group and will not receive any intervention.
The intervention will include study visits in the form of home visits and phone calls performed by CHWs during which they will remind patients about upcoming visits, ensure patient has sufficient medications, review medication schedule and provide education as needed.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 72 is close to the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for patient participant:
Exclusion Criteria for patient participant and historical patient reference group:
Inclusion Criteria for CHW
Exclusion Criteria for CHW
Inclusion criteria for healthcare staff (provider/administrator)
Exclusion criteria for healthcare staff (provider/administrator)
Discharged HF patients in rural Haiti will be receive a follow-up care program delivered by trained community health workers (CHWs).
Other: HF follow up care
Historical reference group who received standard of care for HF identified prior to CHW training.
Other: HF Standard of Care (SOC)
The intervention will consist of follow up phone calls and visits during which the CHWs will remind patients about upcoming visits, ensure patient has sufficient medications, review medication schedule and provide education as needed.
SOC after discharge for HF is to notify patients of a follow-up visit at the hospital/clinic - about 7 days after discharge and provide patients about 30 days of medications at discharge. If a patient does not return for a follow-up appointment, there are no systems to track this missed visit, or to trigger active attempts to contact patients. For patients who come back to their scheduled 7-day visit, there is generally a 14-day visit followed by a 28-day visit.
The Number of Participants Who Reported the HF Follow up Program by CHWs Was Acceptable
Acceptability of the HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Did you find it acceptable to have a CHW visit your home within 5 days of hospital discharge?" 1=poor, 2=fair, 3=ok, 4=good, 5=great. Acceptable was defined as the visit being good or great.
Time frame: 90 days
The Number of Participants Who Reported That the HF Follow up Program Appropriate
Appropriateness of HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Did you find it appropriate to be assigned a community health worker when you left the hospital?" where 1=poor, 2=fair, 3= ok, 4=good, 5= great. Appropriate was defined as good or great.
Time frame: 90 days
The Number of Participants Who Consent to Participate in the HF Follow up Program
The number of participants who consent to participate in the HF follow up program out of the total number of eligible participants.
Time frame: 90 days
Completed Items in the Home Visit Checklist
Mean percent of home visit items from a checklist completed for all participants. The higher the percentage, the greater the fidelity of the program.
Time frame: 90 days
Number of Participants Who Completed a Scheduled Visit
Number of participants who completed a scheduled visit within 30 days of hospital discharge.
Time frame: 90 days
Number of Participants With All Home Visit Checklist Items Completed
Number of participants with all home visit checklist items completed.
Time frame: 90 days
Linkage of HF Patients
Number of patients that complete 30 day follow up visit
Time frame: 30 days
6 CHWs were enrolled and trained to deliver the intervention to the patients with HF. The CHWs then conducted a home visit and delivered education to patients in their homes. Some baseline Characteristics were not collected for CHWs.
| Milestone | Follow up Care Program for HF Patients | Community Health Workers | Standard of Care |
|---|---|---|---|
| Started | 30 | 6 | 36 |
| Completed | 29 | 6 | 36 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
Acceptability of the HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Did you find it acceptable to have a CHW visit your home within 5 days of hospital discharge?" 1=poor, 2=fair, 3=ok, 4=good, 5=great. Acceptable was defined as the visit being good or great.
| Participants | Follow up Care Program for HF Patients | Standard of Care |
|---|---|---|
| The Number of Participants Who Reported the HF Follow up Program by CHWs Was Acceptable | 24 | — |
Appropriateness of HF follow up program to patients will be assessed using a 5-point Likert scale response to the question "Did you find it appropriate to be assigned a community health worker when you left the hospital?" where 1=poor, 2=fair, 3= ok, 4=good, 5= great. Appropriate was defined as good or great.
| Participants | Follow up Care Program for HF Patients | Standard of Care |
|---|---|---|
| The Number of Participants Who Reported That the HF Follow up Program Appropriate | 22 | — |
The number of participants who consent to participate in the HF follow up program out of the total number of eligible participants.
| Participants | Follow up Care Program for HF Patients | Standard of Care |
|---|---|---|
| The Number of Participants Who Consent to Participate in the HF Follow up Program | 29 | — |
Mean percent of home visit items from a checklist completed for all participants. The higher the percentage, the greater the fidelity of the program.
| percent of checklist items completed | Follow up Care Program for HF Patients | Standard of Care |
|---|---|---|
| Completed Items in the Home Visit Checklist | 90.7 ± 11.7 | — |
Number of participants who completed a scheduled visit within 30 days of hospital discharge.
| Participants | Follow up Care Program for HF Patients | Standard of Care |
|---|---|---|
| Number of Participants Who Completed a Scheduled Visit | 21 | — |
Number of participants with all home visit checklist items completed.
| Participants | Follow up Care Program for HF Patients | Standard of Care |
|---|---|---|
| Number of Participants With All Home Visit Checklist Items Completed | 5 | — |
Number of patients that complete 30 day follow up visit
| Participants | Follow up Care Program for HF Patients | Standard of Care |
|---|---|---|
| Linkage of HF Patients | 20 | 9 |
Collected over 90 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Follow up Care Program for HF Patients | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Standard of Care | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Continuous(years) | Follow up Care Program for HF Patients | Community Health Workers | Standard of Care | Total |
|---|---|---|---|---|
| Mean | 52.7 ± 17.1 | — | 50.6 ± 20.8 | 51.6 ± 19.1 |
| Sex: Female, Male(Participants) | Follow up Care Program for HF Patients | Community Health Workers | Standard of Care | Total |
|---|---|---|---|---|
| Female | 15 | — | 17 | 32 |
| Male | 15 | — | 19 | 34 |
| Ethnicity (NIH/OMB)(Participants) | Follow up Care Program for HF Patients | Community Health Workers | Standard of Care | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 30 | 6 | 36 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Follow up Care Program for HF Patients | Community Health Workers | Standard of Care | Total |
|---|---|---|---|---|
| Black | 30 | 6 | 36 | 72 |
| Region of Enrollment(participants) | Follow up Care Program for HF Patients | Community Health Workers | Standard of Care | Total |
|---|---|---|---|---|
| Haiti | 30 | 6 | 36 | 66 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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