Mind Your Heart Study

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

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

Study Overview

• Status: Completed
• Conditions: Medication Non-adherence
• Intervention / Treatment: Behavioral: Mindfulness Training (MT)

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfulness Training (MT); Eight, 30-minute phone delivered MT sessions once a week for 8 weeks

Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Flanker Inhibitory Control and Attention Test	Cognitive function was assessed using the NIH Toolbox Fluid Cognition Battery. Each neurocognitive test was independently completed by study participants (3-5 minutes each) using a study tablet after a baseline practice trial. For each cognitive measure we report age-adjusted scores, which are automatically generated by the NIH Toolbox software. For all measures, higher scores indicate better cognitive performance. The Flanker Inhibitory Control and Attention Test is a measure of executive function, attention and inhibitory control. Participants are instructed to focus on a stimulus while inhibiting attention to another stimulus (arrows). Sometimes the middle stimulus points in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent) over 20 trials.	baseline, 3 months, 6 months
The Dimensional Change Card Sort Test	The Dimensional Change Card Sort Test is a measure of cognitive flexibility and attention. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). The relevant dimension for sorting is indicated by a cue word (e.g., "shape" or "color") that appears on the screen for all participants. Age-adjusted scores are calculated automatically by the NIH Toolbox software. Higher scores indicate better function.	Baseline, 3 months, 6 months
Oral Symbol Digit Test	The Oral Symbol digit test is a measure of working memory and processing speed. A key with nine abstract symbols is presented - each paired with a number between 1 and 9. Participants are asked to verbally indicate which numbers go with the symbols that are presented in a long string on the computer screen. The participant is given 120 seconds to call out as many numbers that go with the corresponding symbols as he/she can - in order, without skipping any. Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function.	baseline, 3 months, 6 months
Picture Sequence Memory Test	The Picture Sequence Memory Test is a measure of episodic memory. Sequences of pictured objects and activities are presented in a particular order. The participants are asked to reproduce the sequence of pictures that is shown on the screen. Participants respond by dragging pictures from the yellow box on the screen into the gray boxes on the screen. Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function.	baseline, 3 months, 6 months
List Sorting Working Memory Test	The List Sorting Working Memory Test is a measure of working memory. Pictures of foods and animals are displayed with accompanying audio recording and written text (e.g., "elephant"), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods) and then on two dimensions (foods, then animals). Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function.	baseline, 3 months, 6 months
Depressive Symptoms	Hospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity.	baseline, 3 months, 6 months
Sleep Quality	Pittsburgh Sleep Quality Index. Self-report measure of sleep quality and quantity. Higher scores indicate better sleep quality and quantity. The overall score range is 0-21.	baseline, 3 months, 6 months
Interoceptive Awareness: Noticing Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the noticing subscale score was 0-20.	baseline, 3 months, 6 months
Interoceptive Awareness: Not Distracting Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the not distracting subscale score was 0-15.	baseline, 3 months, 6 months
Interoceptive Awareness: Not Worrying Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the not-worrying subscale was 0-15.	baseline, 3 months, 6 months
Interoceptive Awareness: Attention Regulation Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the attention regulation subscale score was 0-35.	baseline, 3 months, 6 months
Interoceptive Awareness: Emotional Awareness Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the emotional awareness score was 0-25.	baseline, 3 months, 6 months
Interoceptive Awareness: Self-regulation Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the self-regulation score was 0-20.	baseline, 3 months, 6 months
Interoceptive Awareness: Body Listening Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the body listening score was 0-15.	baseline, 3 months, 6 months
Interoceptive Awareness: Trusting Score	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the trusting subscale score was 0-15.	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Elena Salmoirago-Blotcher, MD, PhD, The Miriam Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Heart failure; Medication adherence; Mindfulness interventions
• Other Study ID Numbers: R21HL140492 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data generated under the project will be shared as per the NIH Grant Policy and The Miriam Hospital IRB guidelines. De-identified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be de-identified to avoid linkages to individual research participants and will not contain variables that could lead to the disclosure of the identity of individual subjects. All requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or SPSS file formats.
• IPD Sharing Time Frame: Once the main findings from the final research data set have been accepted for publication.
• IPD Sharing Access Criteria: Researchers interested in obtaining the de-identified data and associated documentation (e.g. codebook) can make a request to the principal investigator by email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No