Mind Your Heart-II
Part of paid clinical trials in Providence, Rhode Island.
- Sponsor
- The Miriam Hospital
- Study ID
- NCT05431192
- Status
- Recruiting
Conditions
- Cognitive Impairment
- Heart Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mindfulness Training + Enhanced Usual Care — BEHAVIORALParticipants 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 — OTHERUsual 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 CareParticipants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
- Other: Enhanced Usual Care aloneUsual 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
- Elena Salmoirago-Blotcher, MD, PhD401-793-8325
- Janice Tripolone, MS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | - |
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