Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Improving medication adherence for heart failure patients with family support

Official title: Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies in Patients With Heart Failure

Run by The University of Tennessee, Knoxville · NCT05548413 · Data updated 2026-11-12

This study is testing whether getting family support can help heart failure patients take their medications as prescribed and improve their health.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment328 (estimated)
SponsorThe University of Tennessee, Knoxville
Academic / other
Locations1 site (Lexington, Kentucky)
StatusRecruiting
StartedJanuary 4, 2023
Main results expectedJune 30, 2027
Study endsDecember 31, 2027
Registry record updatedMay 5, 2026
Trial IDNCT05548413 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are heart failure patients with suboptimal medication adherence who have a supportive care partner involved in their care.

Probably not a fit

Patients with cognitive impairments or recent hospitalizations may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention focuses on enhancing medication adherence among heart failure patients by involving their care partners in the process. Nurses will coach patients and their care partners using easy-to-understand language and various interactive techniques such as teach-back, role-playing, and goal setting. The aim is to identify and overcome barriers to adherence, ultimately improving patient outcomes and reducing hospitalizations. The intervention is designed to be literacy-sensitive and family-focused, addressing the significant role of health literacy in medication adherence.

Why it matters

Potential benefit: If successful, this intervention could significantly improve medication adherence, reduce hospitalizations, and enhance the quality of life for heart failure patients.

How similar studies have gone: Previous studies have shown some success with family-focused interventions, but this approach is novel in its emphasis on health literacy and sustained engagement.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Jia-Rong Wu
    Lexington, Kentucky, United States
    Recruiting

Study contacts

  • Principal investigator: Jia-Rong Wu — University of Kentucky
  • Study coordinator: Jia-Rong Wu, PhD
  • Email: jiarong.wu2@uky.edu
  • Phone: 8593234712

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.