Clinical trial NCT03571581: Mind Your Heart Study
Official title: Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Non-adherence
Keywords: Medication adherence
Heart failure
Mindfulness interventions
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-06-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Retention Rate
timeFrame: 3 months, 6 months
measure: Intervention Acceptability
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported Medication Adherence
timeFrame: baseline, 3 months, 6 months
measure: Objectively-assessed Medication Adherence
timeFrame: baseline, 3 months, 6 months
measure: Functional Capacity
timeFrame: baseline, 3 months, 6 months
Other outcomes:
measure: The Flanker Inhibitory Control and Attention Test
timeFrame: baseline, 3 months, 6 months
measure: The Dimensional Change Card Sort Test
timeFrame: Baseline, 3 months, 6 months
measure: Oral Symbol Digit Test
timeFrame: baseline, 3 months, 6 months
measure: Picture Sequence Memory Test
timeFrame: baseline, 3 months, 6 months
measure: List Sorting Working Memory Test
timeFrame: baseline, 3 months, 6 months
measure: Depressive Symptoms
timeFrame: baseline, 3 months, 6 months
measure: Sleep Quality
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Noticing Score
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Not Distracting Score
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Not Worrying Score
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Attention Regulation Score
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Emotional Awareness Score
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Self-regulation Score
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Body Listening Score
timeFrame: baseline, 3 months, 6 months
measure: Interoceptive Awareness: Trusting Score
timeFrame: baseline, 3 months, 6 months
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Elena Salmoirago-Blotcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmoirago-Blotcher E. A treatment in search of a disease? Challenges in mindfulness research and practice. Explore (NY). 2022 Sep-Oct;18(5):509-514. doi: 10.1016/j.explore.2021.05.005. Epub 2021 May 26.
citation: Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsinger S, Levine D, Breault C, Wu JR, Bock B, Cohen R. Exploring effects of mindfulness training on medication adherence in patients with heart failure: THE MIND YOUR HEART STUDY. Annals of Behavioral Medicine. 2021; 55: S210-S210.
citation: Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Levine D, Breault C, Wu JR, and Cohen R.Effects Of Mindfulness Training On Cognitive Function And Interoceptive Awareness In Heart Failure Outpatients. Circulation 2021;144:A9159-A9159.
citation: Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Breault C, Levine D, Wu JR, Cohen R. Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):595-602. doi: 10.1097/JCN.0000000000000891. Epub 2022 Jan 24.