Recruiting

Medication Adherence

Sponsor:

Jia-Rong Wu

Code:

NCT05548413

Conditions

Medication Adherence

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FamLit

Attention Control

Study Details

Brief summary:

People with heart failure who do not take their medications as prescribed are at high risk of complications leading to hospitalization, death and poor quality of life. In the proposed intervention, nurses will use easy-to-understand language to coach patients and their care partners to help them work together and build skills to overcome their individual barriers to adherence in order to 1) improve and sustain patient medication adherence; 2) reduce hospitalization; 3) improve quality of life. If effective, this intervention will support long-term medication adherence, thus reducing hospitalizations related to heart failure and quality of life.

Conditions

Medication Adherence

Heart Failure

Study ID

NCT05548413

Start date

Jan 4, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

328 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Patients - Attention Only

Patients with a confirmed diagnosis of heart failure.

active comparator: Care Partners - Attention Only

Care partners of patients with a confirmed diagnosis of heart failure.

experimental: Patients - FamLit

Patients with a confirmed diagnosis of heart failure.

experimental: Care Partners - FamLit

Care partners of patients with a confirmed diagnosis of heart failure.

Interventions

FamLit

The FamLit (Family-focused and Literacy-sensitive strategy) is an interactive, multi-component intervention supported by the FamLit intervention Guide, including both spoken and printed materials written at a 4th-grade reading level for HF patients and their primary CPs.Three constructs guide the intervention, based on the Theory of Planned Behavior (TPB): 1) develop patient and CP positive attitudes through HF instruction and teach-back; 2) form positive subjective norms through coaching to improve patient and CP communication, support, and teamwork; and 3) increase perceived behavioral control through coaching and role-playing to empower patients and CPs to overcome individual barriers to adherence. This intervention also includes use of the SimpleMed+ electronic pillbox.

Attention Control

Participants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox.

Primary outcome measure

  • Medication adherence [ Time Frame: 12 months ]
  • Self-reported medication adherence. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jia-Rong Wu, PhD

8593234712jiarong.wu2@uky.edu

Locations

Jia-Rong Wu

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Jia-Rong Wu, PhD

859-323-4712jiarong.wu2@uky.edu

More Information

Sponsor

Jia-Rong Wu

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • care partner
  • family
  • health literacy
  • teach back

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jia-Rong Wu on 2026-05-05.