Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
- Conditions
- Medication AdherenceHeart Failure
- Interventions
- Behavioral: Attention ControlBehavioral: FamLit
- Registration Number
- NCT05548413
- Lead Sponsor
- Jia-Rong Wu
- 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.
- Detailed Description
Medication adherence is thought by many providers and researchers to be the most important self-care behavior, yet it is also the most problematic. Poor medication adherence can cause poor quality of life (QoL), hospitalization, and death. In the United States, approximately 125,000 deaths per year are due to poor medication adherence and up to 50% of heart failure (HF) patients are re-hospitalized within 6 months of a previous HF exacerbation and one of the most common causes is poor medication adherence. Lifelong and usually complex medication regimens are needed for patients with HF, yet 40-60% of HF patients have suboptimal medication adherence. Health literacy plays a significant role in suboptimal medication adherence. Support by a care partner (CP; usually a family member) can improve adherence and reduce hospitalizations. Although some interventions have improved HF patients' adherence, improvements were small, and effects were not sustained. To enhance and sustain intervention effects, an approach that is literacy-sensitive and incorporates social support will be used. Using easy-to-understand language for patients and CPs, investigators will test an interactive, behavioral, family-focused and literacy-sensitive (FamLit) intervention delivered by nurses, incorporating evidence-based, multi-components (e.g., teach-back, coaching, role-playing, goal setting) to engage both patients and CPs in improving and sustaining medication adherence and health outcomes. A randomized controlled trial will be conducted to evaluate the efficacy of FamLit intervention on medication adherence, hospitalization, death, and QoL. 164 dyads of patients and their primary CPs (patients-CPs) will be randomly assigned to either the FamLit intervention or an attention-control group. Both groups will have an in-person session (delivered on the day of a clinic appointment for regular follow-up) one month after baseline and phone boosters every other week for up to 3 months. FamLit group sessions will focus on improving medication adherence, and control group sessions will focus on general health issues. Aims are to: 1) test the efficacy of the FamLit intervention compared to an attention control group on outcomes (i.e., primary: medication adherence, and secondary: a) HF hospitalization or all-cause death, b) QoL over 12 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 328
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients - Attention Only Attention Control Patients with a confirmed diagnosis of heart failure. Patients - FamLit FamLit Patients with a confirmed diagnosis of heart failure. Care Partners - FamLit FamLit Care partners of patients with a confirmed diagnosis of heart failure. Care Partners - Attention Only Attention Control Care partners of patients with a confirmed diagnosis of heart failure.
- Primary Outcome Measures
Name Time Method Medication adherence 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. 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.
- Secondary Outcome Measures
Name Time Method Patient hospitalization 12 months Percentage of patients hospitalized. HF hospitalizations will be determined by a combination of medical record review and monthly phone interviews with patients and/or care partners to collect data for all encounters.
Quality of life - Minnesota Living with Heart Failure 12 months The 21-item Minnesota Living with Heart Failure (MLHF) questionnaire measures the patient's perceptions of the influence of HF on physical and emotional aspects of life. The items are scored on a Likert scale from 0 (No) to 5 (Very much). The scores of the 21 items will be summed with higher scores of the MLHF indicating worse quality of life.
Positive Affect 12 months Generic quality of life will be assessed using the NeuroQoL Positive Affect and Well-Being short form, which has 9 items and each item is rated on a 5-point Likert scale from 1 (never) to 5 (always); higher scores indicate better quality of life.
Trial Locations
- Locations (1)
Jia-Rong Wu
🇺🇸Lexington, Kentucky, United States