Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Medication Non-adherence
- Sponsor
- The Miriam Hospital
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Retention Rate
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Elena Salmoirago-Blotcher
Research Scientist
The Miriam Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Retention Rate
Time Frame: 3 months, 6 months
Percentage of participants retained in the study (n enrolled/n retained X 100)
Intervention Acceptability
Time Frame: 3 months
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).
Secondary Outcomes
- Objectively-assessed Medication Adherence(baseline, 3 months, 6 months)
- Self-reported Medication Adherence(baseline, 3 months, 6 months)
- Functional Capacity(baseline, 3 months, 6 months)