Mind Your Heart-II

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
The Miriam Hospital
Study ID
NCT05431192
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Nov 30, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Mindful Training + Enhanced Usual Care
    Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
  • Other: Enhanced Usual Care alone
    Usual care.

Primary Outcome Measure

Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery. [ Time Frame: Baseline, 3 months, 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Miriam HospitalProvidenceRhode Island02906-

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