Mind Your Heart-II (MYH-II)

Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cognitive Impairment
• Intervention / Treatment: Behavioral: Mindfulness Training + Enhanced Usual Care; Other: Enhanced Usual Care

Detailed Description

Stable outpatients patients with co-morbid heart failure (HF) and mild cognitive impairment (MCI) (n=176) will be randomly assigned to phone-delivered MT (a weekly, 30-minute session for 8 weeks integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Per current recommendations, usual care will be enhanced in both groups with self-care education materials. At baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers.

This study has the following objectives:

1. To study the role of MT in improving cognitive function and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 1a) Cognitive function will improve in MT vs. EUC at end of treatment (3 months); 1b) Improvements in cognitive function at end of treatment will mediate effects on self-care and HF biomarkers at follow-up (9 months since baseline).
2. To study the role of MT in improving interoceptive awareness and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 2a) Interoceptive awareness will improve in MT vs. EUC at 3 months, and 2b) Changes in interoceptive awareness at end of treatment will mediate improvements in self-care and HF biomarkers at 9 months follow-up.
3. To study the mechanistic pathway linking MT, vagal control and cognitive function. We hypothesize: 3a) Vagal control will improve in MT vs. EUC at end of treatment (3 months); 3b) Changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Salmoirago-Blotcher, MD, PhD; Phone Number: 401-793-8325; Email: Elena_Salmoirago-Blotcher@brown.edu
• Study Contact Backup: Name: Janice Tripolone, MS; Email: JTripolone@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • 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 years old
• A documented diagnosis of HF
• Access to a telephone
• Mild cognitive impairment (MoCA score < = 26)
• Ability to understand and speak English or Spanish

Exclusion Criteria:

• Unwillingness/inability to provide informed consent
• Reversible causes of HF (e.g., takotsubo syndrome; myocarditis)
• Severe hearing impairment not allowing phone delivery
• Suicidal ideation or plan
• Current (at least once a month) mind/body practice
• Planning to move out of the area during the study period
• Severe cognitive impairment (MoCA scores < 15)
• New York Heart Association (NYHA) class IV heart failure or clinically unstable
• Ongoing psychiatric or neurologic conditions
• Current enrollment in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful Training + Enhanced Usual Care; Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.	Behavioral: Mindfulness Training + Enhanced Usual Care; Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. MT involves training in the following (1) Awareness of breath; (2) Body scan; (3) Directing attention to simple activities of daily life; (4) Becoming aware of own thoughts and emotions; (5) "Open awareness" - a technique by which the participant is invited to direct his/her attention to any event arising in their field of experience at a given moment. In addition, participants will practice mindfulness techniques for 20 minutes daily on their own with the guidance of a digitally recorded, standardized guided mindfulness practice.
Other: Enhanced Usual Care alone; Usual care.	Other: Enhanced Usual Care; Usual care will be enhanced in BOTH conditions with printed education materials provided to all participants using publicly available materials (the "Healthier Living with Heart Failure" guide available at the AHA Heart Failure Resource Center).66 The guide is organized in 7 chapters containing information on topics such as understanding HF, making healthy lifestyle changes, managing HF symptoms, taking medications, and living well with HF. Printed materials will be mailed weekly to all participants during the first 8 weeks of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.	The NIH Toolbox is comprised of seven cognitive tests, of which two measure crystallized cognitive ability (i.e., vocabulary and reading) and five tests measure fluid cognitive functioning (i.e., working memory, memory, speed of processing, and executive function). The fluid cognition composite score is obtained by averaging the normalized scores of the Fluid Cognition measures. Higher scores indicate higher levels of functioning. A score ~ 100 indicates average fluid cognitive ability compared with others nationally. Scores ~115 suggest above-average ability, while scores ~130 suggest superior ability. Conversely, a score in the range of 85 suggests below-average ability, and a score ~ 70 or below suggests significant impairment.	Baseline, 3 months, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.	The 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'. Higher scores on each subscale indicate higher levels of interoceptive awareness.There are no standard normal values for each MAIA sub-scale; the range in previous samples from our group for the Not Distracting Score was 1-14. ; MAIA: Not Worrying Score 4-13; MAIA: Attention Regulation Score 4-35; MAIA: Emotional Awareness Score 5-25; MAIA: Self-Regulation Score 4-20; MAIA: Body Listening Score 1-15; MAIA: Trusting Score 3-15.	Baseline, 3 months, 9 months
Change in average Heart Failure (HF) Self-Care total scores.	The Self-care of HF Index (SCHFI) v.7.2., is a psychometrically valid, self-report instrument with three separate scales: Self-Care Maintenance (which captures treatment adherence and healthy behaviors), Symptom Perception (which assesses the ability to detect and interpret physical symptoms), and Self-Care Management (the response to symptoms when they occur). Reliability is > 0.70 and scores range from 0 to 100; higher scores indicate better self-care.	Baseline, 3 months, 9 months
Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).	The HADS is a self-reported measure with two sub-scales (scores 0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity. A good correlation has been reported between the HADS and other commonly used measures of depression. The HADS has been validated in cardiac patients.	Baseline, 3 months, 9 months
Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.	The Kansas City Cardiomyopathy Questionnaire (KCCQ) quantifies HF-specific physical limitations, symptom frequency, severity and change over time, overall quality of life, social interference, and knowledge. Responses are scored on a Likert scale and summed. Higher scores indicate higher quality of life. Construct validity and sensitivity of the KCCQ have been demonstrated.	Baseline, 3 months, 9 months
Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.	High-frequency band is an index of cardiovagal control. High frequency power (hf-HRV) in Ln msec2 , a demonstrated index of vagal activity, will be determined by averaging high frequency values for 10 minute segments at each visit. The proposed methods are based on standards established in the literature.	Baseline, 3 months, 9 months
Change in average 6-min walk test (6MWT) distance.	The 6MWT 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, 9 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.	NT-proBNP is a marker of HF disease severity, elevated filling pressures, clinical outcomes, and is responsive to interventions (e.g., exercise). Specimens are collected in a plastic EDTA tube , centrifuged and separated plasma samples are stored at -20°C until testing. Assays will be analyzed using the ADVIA Centaur BNP assay, a fully automated two-site sandwich immunoassay using direct chemiluminescent technology . The ADVIA Centaur BNP assay measures BNP concentrations up to 5000 pg/mL with a minimum detectable concentration (analytical sensitivity) of < 2.0 pg/mL and shows high specificity for BNP.	Baseline, 3 months, 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF hospital readmissions	Proportion of patients admitted to the hospital with a diagnosis of HF. HF hospital admissions will be tracked via EMR and direct inquiry with participants.	9 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Elena Salmoirago-Blotcher, MD, PhD, Cardiovascular Institute, The Miriam Hospital, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Anticipated): December 2, 2026
• Study Completion (Anticipated): June 2, 2027

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Cognition Disorders; Heart Failure; Cognitive Dysfunction
• Other Study ID Numbers: R01AG076438 (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. Deidentified 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 deidentified 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. analytical code) 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