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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Jia-Rong Wu
Study ID
NCT05548413
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 4, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
328 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Medication adherence [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jia-Rong WuLexingtonKentucky40536
Jia-Rong Wu, PhD
[email protected]
859-323-4712

Find similar trials in Lexington, KY

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Jia-Rong Wu· Lexington, KY

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