Mind Your Heart Study

Medication Non-adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571581
• Other study ID #: R21HL140492
• Secondary ID: R21HL140492
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2022
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 31, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Non-adherence

Intervention

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.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 Wit — View 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.

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 Medici

Salmoirago-Blotcher E. A treatment in search of a disease? Challenges in mindfulness research and practice. Explore (NY). 2021 May 26. pii: S1550-8307(21)00094-X. doi: 10.1016/j.explore.2021.05.005. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Depressive Symptoms	Hospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity.	baseline, 3 months, 6 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Retention Rate	Percentage of participants retained in the study (n enrolled/n retained X 100)	3 months, 6 months
Primary	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	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
Secondary	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
Secondary	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