Mind Your Heart Study

Medication Non-adherence Clinical Trial

Official title: Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.

Status Completed

Clinical Trial Summary

This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.

Clinical Trial Description

This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF). A prospective pre/post design study was conducted among 50 stable outpatients with HF and sub-optimal self-reported medication adherence. MT sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. Assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. The primary outcomes were feasibility and acceptability. We hypothesized we would meet recruitment goals (n=50) within the study timeline, with < 20% drop out rates by the end of the study and that > 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). Secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. We hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. Additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness. ;

Related Conditions & MeSH terms

• Medication Non-adherence

• NCT number: NCT03571581
• Study type: Interventional
• Source: The Miriam Hospital
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Completion date: August 31, 2020