NCT05548413 Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
| NCT ID | NCT05548413 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jia-Rong Wu |
| Condition | Medication Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 328 participants |
| Start Date | 2023-01-04 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 328 participants in total. It began in 2023-01-04 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Jia-Rong Wu
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT05548413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Medication Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05548413 currently recruiting?
Yes, NCT05548413 is actively recruiting participants. Contact the research team at jiarong.wu2@uky.edu for enrollment information.
Where is the NCT05548413 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT05548413 clinical trial?
NCT05548413 is sponsored by Jia-Rong Wu. The principal investigator is Jia-Rong Wu at University of Kentucky. The trial plans to enroll 328 participants.