Mind Your Heart Study

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

Detailed Description
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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.

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

Conditions
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Medication Non-adherence

Intervention / Treatment
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* Behavioral: Mindfulness Training (MT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > = 18 Fluency in English language A confirmed diagnosis of heart failure Sub-optimal adherence to medications Access to a telephone Ability to understand and speak English Exclusion Criteria: Unwillingness/inability to provide informed consent New York Heart Association (NYHA) class IV heart failure or clinically unstable Severe hearing impairment not allowing phone delivery Severe depressive symptoms Acute psychosis Severe cognitive impairment Recent hospitalization (< 6 weeks) Current (at least once a month) mind/body practice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Training (MT)<br>Eight, 30-minute phone delivered MT sessions once a week for 8 weeks | Behavioral: Mindfulness Training (MT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | Percentage of participants retained in the study (n enrolled/n retained X 100) | 3 months, 6 months | 
| Intervention Acceptability | Self-reported intervention enjoyment scale (1 = did not enjoy to 5 = enjoyed very much). Scores range from 1 to 5; higher scores mean a better outcome. The metric for this study was the percentage of participants indicating high intervention enjoyment (a score of 5). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Medication Adherence | The Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence. | baseline, 3 months, 6 months | 
| Objectively-assessed Medication Adherence | Medication Event Monitoring Systems (MEMS). Proportion of medication taken/medication prescribed x 100, averaged over 30 days. Range is 0-100%. Lower values indicate worse adherence. | baseline, 3 months, 6 months | 
| Functional Capacity | 6-min walk test (6MWT) distance. The 6 min walk test measures the distance a patient can walk on a level course in 6 min. It is a measure of functional capacity that correlates with peak oxygen uptake and is positively associated with survival in patients with cardiovascular disease. A higher value (in meters) indicates better functional capacity. The 6MWT distance in healthy adults has been reported to range from 400 to 700 meters. | baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Heart failure, Mindfulness interventions