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Can coaching families boost heart failure pill-taking?

NCT ID NCT05548413

Disease control Sponsor: Jia-Rong Wu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a program called FamLit, where nurses use simple language to coach heart failure patients and their care partners on working together to overcome barriers to taking medications as prescribed. The goal is to improve medication adherence, reduce hospitalizations, and enhance quality of life. The trial enrolls 328 patients with a care partner, all of whom have trouble sticking to their medication routine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FamLit behavioral intervention (coaching for patients and care partners)
What this could lead to
If it works, this program could help heart failure patients stick to their medications, leading to fewer hospitalizations and better daily life.
What could go wrong
This is a behavioral study, not a drug trial, so results depend on patient and family engagement. It may not work for everyone, and benefits might not be large or long-lasting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 328 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria - Patient Participants: * confirmed diagnosis of heart failure (HF), either systolic or diastolic HF * ave suboptimal medication adherence * have a care partner (CP) (either spouse, daughter/son, partner, other relative, friend) who is identified by the patient as the person most involved in HF care * willingness to have a CP be involved in their medication taking * have undergone evaluation of HF and prescribed stable doses of HF medications for at least 3 months * live in a setting where the patient is responsible for their ow medication administration * willing to use the SimpleMed+ (i.e., an electronic pillbox to measure objective medication adherence) * availability by phone Exclusion Criteria - Patient Participants: * cognitive impairment as indicated by having difficulties to understand and give informed consent * a recent hospitalization within 3 months of study enrollment * co-existing end-stage renal disease or terminal illness such as advanced malignancy, or any other condition with less than 1-year life expectancy * psychotic illness * current alcohol dependence or other substance abuse * inability to speak English or other communication barrier * currently or have received any similar self-care intervention recently in the past year Inclusion Criteria - Care Partners: * unpaid family member, friend, partner, or other relation who is involved in the patients' care at least 3 times a week, designated by the patient * willing to receive interventions with the patient together * 18 years of age or older Exclusion Criteria - Care Partners: * cognitive impairment as indicated by having difficulties to understand and give informed consent * coexisting terminal illness * non-English speaking or any other communication barrier

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Conditions

The condition(s) this trial relates to.

heart failure Medication Adherence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Medication adherence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jia-Rong Wu

    RECRUITING

    Lexington, Kentucky, 40536, United States

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