RecruitingNot ApplicableNCT05548413

Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies

Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies in Patients With Heart Failure

Sponsor

Jia-Rong Wu

Enrollment

328 participants

Start Date

Jan 4, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Medication Adherence

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

Min Age: 18 Years

Inclusion Criteria11

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
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
years of age or older

Exclusion Criteria10

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
cognitive impairment as indicated by having difficulties to understand and give informed consent
coexisting terminal illness
non-English speaking or any other communication barrier

Interventions

BEHAVIORALFamLit

The FamLit (Family-focused and Literacy-sensitive strategy) is an interactive, multi-component intervention supported by the FamLit intervention Guide, including both spoken and printed materials written at a 4th-grade reading level for HF patients and their primary CPs.Three constructs guide the intervention, based on the Theory of Planned Behavior (TPB): 1) develop patient and CP positive attitudes through HF instruction and teach-back; 2) form positive subjective norms through coaching to improve patient and CP communication, support, and teamwork; and 3) increase perceived behavioral control through coaching and role-playing to empower patients and CPs to overcome individual barriers to adherence. This intervention also includes use of the SimpleMed+ electronic pillbox.

BEHAVIORALAttention Control

Participants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox.