Mind Your Heart Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2020-08-31

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.

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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.

Conditions

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Medication Non-adherence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Training (MT)

Eight, 30-minute phone delivered MT sessions once a week for 8 weeks

Group Type EXPERIMENTAL

Mindfulness Training (MT)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No