Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.
Overview
- Phase
- N/A
- Intervention
- Mindfulness Training + Enhanced Usual Care
- Conditions
- Heart Failure
- Sponsor
- The Miriam Hospital
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Elena Salmoirago-Blotcher
Senior Research Scientist
The Miriam Hospital
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
Arms & Interventions
Mindful Training + Enhanced Usual Care
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
Intervention: Mindfulness Training + Enhanced Usual Care
Enhanced Usual Care alone
Usual care.
Intervention: Enhanced Usual Care
Outcomes
Primary Outcomes
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
Time Frame: Baseline, 3 months, 9 months
The NIH Toolbox is comprised of seven cognitive tests, of which two measure crystallized cognitive ability (i.e., vocabulary and reading) and five tests measure fluid cognitive functioning (i.e., working memory, memory, speed of processing, and executive function). The fluid cognition composite score is obtained by averaging the normalized scores of the Fluid Cognition measures. Higher scores indicate higher levels of functioning. A score \~ 100 indicates average fluid cognitive ability compared with others nationally. Scores \~115 suggest above-average ability, while scores \~130 suggest superior ability. Conversely, a score in the range of 85 suggests below-average ability, and a score \~ 70 or below suggests significant impairment.
Secondary Outcomes
- Change in average 6-min walk test (6MWT) distance.(Baseline, 3 months, 9 months)
- Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.(Baseline, 3 months, 9 months)
- Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.(Baseline, 3 months, 9 months)
- Change in average Heart Failure (HF) Self-Care total scores.(Baseline, 3 months, 9 months)
- Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).(Baseline, 3 months, 9 months)
- Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.(Baseline, 3 months, 9 months)
- Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.(Baseline, 3 months, 9 months)