Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
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.
Conditions:
🦠 Medication Adherence 🦠 Heart Failure
🗓️ Study Start (Actual) 4 January 2023
🗓️ Primary Completion (Estimated) 30 June 2027
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 328
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Lexington, Kentucky, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 September 2022
  • First Submitted that Met QC Criteria 16 September 2022
  • First Posted 21 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024