Mind Your Heart-II

NCT05431192 | Recruiting DMC

• 1 other identifier: R01AG076438
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.

  Baseline, 3 months, 9 months

• Change in average Heart Failure (HF) Self-Care total scores.

  Baseline, 3 months, 9 months

• Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).

  Baseline, 3 months, 9 months

• Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.

  Baseline, 3 months, 9 months

• Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.

  Baseline, 3 months, 9 months

Other Outcomes (1)

• HF hospital readmissions

  9 months

Study Arms (2)

Mindful Training + Enhanced Usual Care

EXPERIMENTAL

Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.

Behavioral: Mindfulness Training + Enhanced Usual Care

Enhanced Usual Care alone

OTHER

Usual care.

Other: Enhanced Usual Care

Interventions

Enhanced Usual Care OTHER

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.

Enhanced Usual Care alone

Mindfulness Training + Enhanced Usual Care BEHAVIORAL

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.

Mindful Training + Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elena Salmoirago-Blotcher, MD, PhD

  Cardiovascular Institute, The Miriam Hospital, Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Salmoirago-Blotcher, MD, PhD

CONTACT

401-793-8325; Elena_Salmoirago-Blotcher@brown.edu

Janice Tripolone, MS

CONTACT

JTripolone@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be masked to intervention allocation. The PI, the co-investigators, and personnel responsible for data management and analysis will be blinded to participants' exposure status. Unblinded personnel will include the PD, the RA, and the MT instructors. Blinding the PD would be impossible given that she will be responsible for randomization and AEs monitoring. The RA will be responsible for data collection and will not be blinded. We note, however, that study participants will independently perform all assessments via computer interface with no RA involvement. The mindfulness instructors will be aware of the allocation status of the participants but will remain masked to the study hypotheses.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: November 30, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Once the main findings from the final research data set have been accepted for publication.
• 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.

Locations

US (1)