Clinical trial NCT05548413: Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
Official title: Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Adherence
Heart Failure
Keywords: care partner
family
health literacy
teach back
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-09-21
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Medication adherence
timeFrame: 12 months
measure: Self-reported medication adherence.
timeFrame: 12 months
Secondary outcomes:
measure: Patient hospitalization
timeFrame: 12 months
measure: Quality of life - Minnesota Living with Heart Failure
timeFrame: 12 months
measure: Positive Affect
timeFrame: 12 months
Other outcomes:
measure: Caregiver Burden
timeFrame: 12 months
measure: Numeracy health literacy
timeFrame: 12 months
measure: Health Literacy
timeFrame: 12 months
measure: Medication Adherence Scale
timeFrame: 12 months
measure: Communication
timeFrame: 12 months
measure: Social Support
timeFrame: 12 months
Locations:
city: Lexington
country: United States
facility: Jia-Rong Wu
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jia-Rong Wu
role: PRINCIPAL_INVESTIGATOR
References: