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.

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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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

176

Study ID:

NCT05431192

Recruitment Status:

Recruiting

Sponsor:

The Miriam Hospital

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There is 1 Location for this study

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The Miriam Hospital
Providence Rhode Island, 02906, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

176

Study ID:

NCT05431192

Recruitment Status:

Recruiting

Sponsor:


The Miriam Hospital

How clear is this clinincal trial information?

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