Clinical trial NCT05431192: Mind Your Heart-II
Official title: Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Cognitive Impairment
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-06-24
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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:

1. 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).
2. 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.
3. 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

Primary outcomes:
measure: Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
timeFrame: Baseline, 3 months, 9 months
Secondary outcomes:
measure: Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.
timeFrame: Baseline, 3 months, 9 months
measure: Change in average Heart Failure (HF) Self-Care total scores.
timeFrame: Baseline, 3 months, 9 months
measure: Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).
timeFrame: Baseline, 3 months, 9 months
measure: Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.
timeFrame: Baseline, 3 months, 9 months
measure: Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.
timeFrame: Baseline, 3 months, 9 months
measure: Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.
timeFrame: Baseline, 3 months, 9 months
measure: Change in average 6-min walk test (6MWT) distance.
timeFrame: Baseline, 3 months, 9 months
Other outcomes:
measure: HF hospital readmissions
timeFrame: 9 months
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Cardiovascular Institute, The Miriam Hospital, Brown University
name: Elena Salmoirago-Blotcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: