NCT05548413

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Jan 2023Dec 2027

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

September 16, 2022

Last Update Submit

April 29, 2026

Conditions

Medication AdherenceHeart Failure

Keywords

care partnerfamilyhealth literacyteach back

Outcome Measures

Primary Outcomes (2)

  • Medication adherence

    Percentage of prescribed doses taken (PDT%) as determined by the electronic SimpleMed+ pillbox. SimpleMed+ will record the date and time that the lid of each compartment is opened and closed. Those data will be used to calculate objective medication adherence: percent prescribed doses taken (PDT%) = (# of doses taken during monitoring period)/(# of prescribed doses during monitoring period) x 100.PDT% ranges from 0-100%.

    12 months

  • Self-reported medication adherence.

    Adherence will be surveyed the Basel Assessment of Adherence Scale (BAAS), a copyrighted, self-reported scale. The BAAS includes 5 yes-no items and one visual analogue scale (VAS). If participants indicate they have missed a dose (a "yes" response) to any of 5 dichotomous items and \<80% on the VAS, they are classified as suboptimally medication adherent.

    12 months

Secondary Outcomes (3)

  • Patient hospitalization

    12 months

  • Quality of life - Minnesota Living with Heart Failure

    12 months

  • Positive Affect

    12 months

Other Outcomes (6)

  • Caregiver Burden

    12 months

  • Numeracy health literacy

    12 months

  • Health Literacy

    12 months

  • +3 more other outcomes

Study Arms (4)

Patients - Attention Only

ACTIVE COMPARATOR

Patients with a confirmed diagnosis of heart failure.

Behavioral: Attention Control

Care Partners - Attention Only

ACTIVE COMPARATOR

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

Behavioral: Attention Control

Patients - FamLit

EXPERIMENTAL

Patients with a confirmed diagnosis of heart failure.

Behavioral: FamLit

Care Partners - FamLit

EXPERIMENTAL

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

Behavioral: FamLit

Interventions

FamLitBEHAVIORAL

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.

Care Partners - FamLitPatients - FamLit
Attention ControlBEHAVIORAL

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

Care Partners - Attention OnlyPatients - Attention Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • years of age or older
  • cognitive impairment as indicated by having difficulties to understand and give informed consent
  • coexisting terminal illness
  • non-English speaking or any other communication barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jia-Rong Wu

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Medication AdherenceHeart Failure

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHeart DiseasesCardiovascular Diseases

Study Officials

  • Jia-Rong Wu

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia-Rong Wu, PhD

CONTACT

8593234712jiarong.wu2@uky.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

January 4, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)