Status:
RECRUITING
Mind Your Heart-II
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Heart Failure
Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
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 integ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05431192
Start Date
November 30 2022
End Date
June 1 2027
Last Update
July 11 2025
Active Locations (1)
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1
The Miriam Hospital
Providence, Rhode Island, United States, 02906