NCT03571581

Mind Your Heart Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Medication Non-adherence

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Training (MT)	Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.

Timeline

• Start date: 2018-10-11
• Primary completion: 2020-03-13
• Completion: 2020-08-31
• First posted: 2018-06-27
• Last updated: 2025-07-14
• Results posted: 2022-08-29

Locations

1 site across 1 country: United States