RecruitingNot ApplicableNCT05431192

Mind Your Heart-II

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


Sponsor

The Miriam Hospital

Enrollment

176 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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

Interventions

BEHAVIORALMindfulness 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.

OTHEREnhanced 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.


Locations(1)

The Miriam Hospital

Providence, Rhode Island, United States

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NCT05431192


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