Heart FailureNCT05091710
Haiti Community Health Workers (CHW) Adaptation
A study testing HF follow up care in people with Heart Failure, run by Boston Medical Center at 1 site in Haiti.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HF follow up care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHaiti
- Study dates
- 23 Feb 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult HF patients
- Hospitalized >48 hours at Hôpital-Universitaire de Mirebalais (HUM)
- Anticipated discharge from HUM within 1-3 days
- Living in Mirebalais Commune, Haiti Inclusion criteria for historical patient reference group
- Adult HF patients
- Hospitalized >48 hours at HUM
Show all 13Show fewer
- Discharged from HUM within the 12 months preceding the intervention
- Living in Mirebalais Commune
- Exclusion Criteria for patient participant and historical patient reference group:
- None
- Adult
- Provide inpatient or outpatient care to HF patients
- Working in in Mirebalais
Who cannot join
- None
- Inclusion criteria for healthcare staff (provider/administrator)
- Hospital leadership involved in supervision of clinical care programs (i.e. Chief Executive Officer, Chief Medical Officer, Chief Operations Officer, Chief Nursing Officer, etc.)
- Leaders of the Community Health Department - including the nurse Director of Community Health, and Community Health Worker Supervisors.
- Healthcare providers at HUM involved in the care of patients with heart failure (i.e. internal medicine physicians, inpatient hospital nurses, outpatient clinic physicians, outpatient clinic nurses, etc.)
- Exclusion criteria for healthcare staff (provider/administrator)
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of a Community Health Worker Intervention to Improve Heart Failure Care in Rural Haiti
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- HF follow up care, HF Standard of Care (SOC)
- Keywords
- Community health worker (CHW), ADAPT-ITT, Haiti
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF follow up careOther
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.
HF Standard of Care (SOC)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Follow up care program for HF patients | Experimental | Discharged HF patients in rural Haiti will be receive a follow-up care program delivered by trained community health workers (CHWs). Receives: Other: HF follow up care |
| Standard of care | Other | Historical reference group who received standard of care for HF identified prior to CHW training. Receives: Other: HF Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Number of Participants Who Completed a Scheduled Visit
Number of participants who completed a scheduled visit within 30 days of hospital discharge.
Measured: 90 days
Number of Participants With All Home Visit Checklist Items Completed
Number of participants with all home visit checklist items completed.
Measured: 90 days
Secondary outcomes (1)
Linkage of HF Patients
Number of patients that complete 30 day follow up visit
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start23 Feb 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gene F Kwan, MD MPH, Principal investigator, Boston Medical Center, Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091710
- Sponsor's protocol ID
- H-41758
- Other IDs
- 1K23HL140133-01A1
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2021
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of a Community Health Worker Intervention to Improve Heart Failure Care in Rural Haiti
- ClinicalTrials.gov ID
- NCT05091710
- Acronym / sponsor ID
- H-41758
- Conditions
- Heart Failure
- Keywords
- Community health worker (CHW), ADAPT-ITT, Haiti
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow up care program for HF patients | Experimental | Other: HF follow up careDischarged HF patients in rural Haiti will be receive a follow-up care program delivered by trained community health workers (CHWs). |
| Standard of care | Other | Other: HF Standard of Care (SOC)Historical reference group who received standard of care for HF identified prior to CHW training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult HF patients
- Hospitalized >48 hours at Hôpital-Universitaire de Mirebalais (HUM)
- Anticipated discharge from HUM within 1-3 days
- Living in Mirebalais Commune, Haiti Inclusion criteria for historical patient reference group
- Adult HF patients
Key exclusion criteria (7 listed)
- None
- Inclusion criteria for healthcare staff (provider/administrator)
- Hospital leadership involved in supervision of clinical care programs (i.e. Chief Executive Officer, Chief Medical Officer, Chief Operations Officer, Chief Nursing Officer, etc.)
- Leaders of the Community Health Department - including the nurse Director of Community Health, and Community Health Worker Supervisors.
- Healthcare providers at HUM involved in the care of patients with heart failure (i.e. internal medicine physicians, inpatient hospital nurses, outpatient clinic physicians, outpatient clinic nurses, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF follow up careThe 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. | Other | Follow up care program for HF patients |
| HF Standard of Care (SOC)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. | Other | Standard of care |
Primary outcome
The Number of Participants Who Reported the HF Follow up Program by CHWs Was Acceptable
Time frame: 90 days
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.
The Number of Participants Who Reported That the HF Follow up Program Appropriate
Time frame: 90 days
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.
The Number of Participants Who Consent to Participate in the HF Follow up Program
Time frame: 90 days
The number of participants who consent to participate in the HF follow up program out of the total number of eligible participants.
Completed Items in the Home Visit Checklist
Time frame: 90 days
Mean percent of home visit items from a checklist completed for all participants. The higher the percentage, the greater the fidelity of the program.
Number of Participants Who Completed a Scheduled Visit
Time frame: 90 days
Number of participants who completed a scheduled visit within 30 days of hospital discharge.
Number of Participants With All Home Visit Checklist Items Completed
Time frame: 90 days
Number of participants with all home visit checklist items completed.
1 secondary outcome
Linkage of HF Patients
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gene F Kwan, MD MPH principal investigator
Boston Medical Center, Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HF follow up care in people with Heart Failure, run by Boston Medical Center at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Who Reported the HF Follow up Program by CHWs Was Acceptable (time frame: 90 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.