Improving medication adherence for heart failure patients with family support
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies in Patients With Heart Failure
This study is testing whether getting family support can help heart failure patients take their medications as prescribed and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Tennessee, Knoxville Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05548413 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on enhancing medication adherence among heart failure patients by involving their care partners in the process. Nurses will coach patients and their care partners using easy-to-understand language and various interactive techniques such as teach-back, role-playing, and goal setting. The aim is to identify and overcome barriers to adherence, ultimately improving patient outcomes and reducing hospitalizations. The intervention is designed to be literacy-sensitive and family-focused, addressing the significant role of health literacy in medication adherence.
Who should consider this trial
Good fit: Ideal candidates are heart failure patients with suboptimal medication adherence who have a supportive care partner involved in their care.
Not a fit: Patients with cognitive impairments or recent hospitalizations may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence, reduce hospitalizations, and enhance the quality of life for heart failure patients.
How similar studies have performed: Previous studies have shown some success with family-focused interventions, but this approach is novel in its emphasis on health literacy and sustained engagement.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lexington, Kentucky
- Jia-Rong Wu — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Jia-Rong Wu — University of Kentucky
- Study coordinator: Jia-Rong Wu, PhD
- Email: jiarong.wu2@uky.edu
- Phone: 8593234712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.