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NCT03571581

Mind Your Heart Study

Completed NA Results posted Last updated 14 July 2025
What this trial tests

NA trial testing Mindfulness Training (MT) in Medication Non-adherence in 33 participants. Completed in 31 August 2020.

Timeline
11 October 2018
Primary endpoint
13 March 2020
31 August 2020

Quick facts

Lead sponsorThe Miriam Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date11 October 2018
Primary completion13 March 2020
Estimated completion31 August 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Miriam Hospital

Who can join

18 and older, any sex, with Medication Non-adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention Rate Primary · 3 months, 6 months

Percentage of participants retained in the study (n enrolled/n retained X 100)

3 months
GroupValue95% CI
Mindfulness Training (MT)31
6 months
GroupValue95% CI
Mindfulness Training (MT)29
Intervention Acceptability Primary · 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).

GroupValue95% CI
Mindfulness Training (MT)24
Self-reported Medication Adherence Secondary · baseline, 3 months, 6 months

The Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence.

Baseline
GroupValue95% CI
Mindfulness Training (MT)2.8± 2.6
3 months
GroupValue95% CI
Mindfulness Training (MT)2.6± 0.6
6 months
GroupValue95% CI
Mindfulness Training (MT)2.6± 0.3
Objectively-assessed Medication Adherence Secondary · baseline, 3 months, 6 months

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
GroupValue95% CI
Mindfulness Training (MT)73± 28
3 months
GroupValue95% CI
Mindfulness Training (MT)58± 35
6 months
GroupValue95% CI
Mindfulness Training (MT)61± 37
Functional Capacity Secondary · baseline, 3 months, 6 months

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
GroupValue95% CI
Mindfulness Training (MT)350± 93
3 months
GroupValue95% CI
Mindfulness Training (MT)378± 97
6 months
GroupValue95% CI
Mindfulness Training (MT)374± 95
The Flanker Inhibitory Control and Attention Test Secondary · baseline, 3 months, 6 months

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 inh

Baseline
GroupValue95% CI
Mindfulness Training (MT)87.9± 14.5
3 months
GroupValue95% CI
Mindfulness Training (MT)93.2± 16.0
6 months
GroupValue95% CI
Mindfulness Training (MT)92.6± 17.6
The Dimensional Change Card Sort Test Secondary · Baseline, 3 months, 6 months

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 ar

Baseline
GroupValue95% CI
Mindfulness Training (MT)101± 19.7
3 months
GroupValue95% CI
Mindfulness Training (MT)100.7± 10.0
6 months
GroupValue95% CI
Mindfulness Training (MT)100.6± 20.1
Oral Symbol Digit Test Secondary · baseline, 3 months, 6 months

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
GroupValue95% CI
Mindfulness Training (MT)58.8± 18.0
3 months
GroupValue95% CI
Mindfulness Training (MT)65.7± 22.0
6 months
GroupValue95% CI
Mindfulness Training (MT)62.8± 23.5
Picture Sequence Memory Test Secondary · baseline, 3 months, 6 months

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
GroupValue95% CI
Mindfulness Training (MT)98.2± 15.2
3 months
GroupValue95% CI
Mindfulness Training (MT)102.1± 18.8
6 months
GroupValue95% CI
Mindfulness Training (MT)109.9± 20.0
List Sorting Working Memory Test Secondary · baseline, 3 months, 6 months

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
GroupValue95% CI
Mindfulness Training (MT)98.2± 13.7
3 months
GroupValue95% CI
Mindfulness Training (MT)101.5± 14.9
6 months
GroupValue95% CI
Mindfulness Training (MT)100.3± 62.8
Depressive Symptoms Secondary · baseline, 3 months, 6 months

Hospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity.

Baseline
GroupValue95% CI
Mindfulness Training (MT)3.6± 3.3
3 months
GroupValue95% CI
Mindfulness Training (MT)4.3± 3.2
6 months
GroupValue95% CI
Mindfulness Training (MT)4.9± 3.6
Sleep Quality Secondary · baseline, 3 months, 6 months

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
GroupValue95% CI
Mindfulness Training (MT)7.2± 3.9
3 months
GroupValue95% CI
Mindfulness Training (MT)6.9± 3.9
6 months
GroupValue95% CI
Mindfulness Training (MT)7.6± 4.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness Training (MT)
Serious: 3/31 (10%)
Deaths: 2/31

Serious adverse events (3 terms)

ReactionSystemMindfulness Training (MT)
sudden cardiac deathCardiac disorders
deathCardiac disorders
strokeNervous system disorders
Other adverse events (8 terms — click to expand)

ReactionSystemMindfulness Training (MT)
influenzaInfections and infestations
uncontrolled hypertensionCardiac disorders
fallMusculoskeletal and connective tissue disorders
Chest painMusculoskeletal and connective tissue disorders
Impacted toothSurgical and medical procedures
pneumoniaInfections and infestations
car accidentSocial circumstances
elective surgerySurgical and medical procedures

Most-reported serious reactions: sudden cardiac death, death, stroke.

Data from ClinicalTrials.gov NCT03571581 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure.
    Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, et al · · 2022 · cited 6× · PMID 35067596 · DOI 10.1097/jcn.0000000000000891

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