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Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies

NCT05548413 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2026-05-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Jia-Rong Wu

    lead OTHER

Principal Investigators

  • Jia-Rong Wu · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548413 on ClinicalTrials.gov