Mind Your Heart Study

Lifespan

Status: Completed

Conditions: Medication Non-adherence

Treatments: Behavioral: Mindfulness Training (MT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03571581

R21HL140492 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Mindfulness Training (MT)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Training (MT)