NCT05548413 · Jia-Rong Wu
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
(FamLit_HF)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Medication adherence
Time frame: 12 months
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%.
Self-reported medication adherence.
Time frame: 12 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Lexington, Kentucky
Collaborators
National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations