Heart Failure Clinical Trial
Mind Your Heart-II
Summary
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
Full 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 integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Per current recommendations, usual care will be enhanced in both groups with self-care education materials. At baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers.
This study has the following objectives:
To study the role of MT in improving cognitive function and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 1a) Cognitive function will improve in MT vs. EUC at end of treatment (3 months); 1b) Improvements in cognitive function at end of treatment will mediate effects on self-care and HF biomarkers at follow-up (9 months since baseline).
To study the role of MT in improving interoceptive awareness and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 2a) Interoceptive awareness will improve in MT vs. EUC at 3 months, and 2b) Changes in interoceptive awareness at end of treatment will mediate improvements in self-care and HF biomarkers at 9 months follow-up.
To study the mechanistic pathway linking MT, vagal control and cognitive function. We hypothesize: 3a) Vagal control will improve in MT vs. EUC at end of treatment (3 months); 3b) Changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Providence Rhode Island, 02906, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.