A multi-component, family-focused and literacy-sensitive intervention to improve medication adherence in patients with heart failure-A randomized controlled trial

Abstract

Background: Medication nonadherence is prevalent and links to serious outcomes (e.g., rehospitalization/death) in heart failure (HF) patients; therefore, an urgent need exists for an intervention to improve and sustain adherence after intervention completion.

Objectives: To test the efficacy of a multi-component, family-focused, literacy-sensitive (FamLit) intervention on medication adherence in HF patients.

Methods: Forty-three HF patients and their care partners were enrolled and randomized to receive FamLit or attention-only intervention, including an in-person session at baseline and bi-weekly phone boosters for 3 months. We measured medication adherence from baseline to 3-month post-intervention using the Medication Event Monitoring System.

Results: After 3-month intervention, intervention patients had significantly better medication adherence than control patients. At 6 months (3-months post-intervention), intervention effect on adherence was sustained in the FamLit intervention group, while adherence decreased in the control group.

Conclusion: Incorporating care partner support and providing an easy-to-understand intervention to patients-care partners may improve/sustain adherence.

Keywords: Behavior intervention; Family intervention; Health literacy; Medication adherence.

Figure 1:

Conceptual framework. The Family-focused, Literacy-sensitive (FamLit) intervention uses multiple strategies that are easy to understand to target three constructs of the Theory of Planned Behavior (TPB): attitudes, subjective norms, and perceived behavioral control, as well as enhance care partner support and patient-care partner communication to improve and sustain patient medication adherence.

Figure 2:

FamLit CONSORT Flow Chart

Figure 3:. Medication adherence between groups over time (N=43):

At the end of 3 months (at completion of the intervention), the intervention group had better medication adherence than the control group (87.6% vs. 80.9%). Repeated measures ANOVA showed a significant group-by-time interaction indicated that medication adherence was sustained in intervention group patients at the end of 6 months (3 months post-intervention), but decreased in the control group over time (p=.031).