Mind Your Heart-II

Study 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: 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.

Official Title
-----------------
Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.

Conditions
-----------------
Heart Failure, Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Training + Enhanced Usual Care
* Other: Enhanced Usual Care


Participation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Training + Enhanced Usual Care<br>Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. | Behavioral: Mindfulness Training + Enhanced Usual Care<br>* Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. MT involves training in the following (1) Awareness of breath; (2) Body scan; (3) Directing attention to simple activities of daily life; (4) Becoming aware of own thoughts and emotions; (5) Open awareness - a technique by which the participant is invited to direct his/her attention to any event arising in their field of experience at a given moment. In addition, participants will practice mindfulness techniques for 20 minutes daily on their own with the guidance of a digitally recorded, standardized guided mindfulness practice.<br>|
| Other: Enhanced Usual Care alone<br>Usual care. | Other: Enhanced Usual Care<br>* Usual care will be enhanced in BOTH conditions with printed education materials provided to all participants using publicly available materials (the Healthier Living with Heart Failure guide available at the AHA Heart Failure Resource Center).66 The guide is organized in 7 chapters containing information on topics such as understanding HF, making healthy lifestyle changes, managing HF symptoms, taking medications, and living well with HF. Printed materials will be mailed weekly to all participants during the first 8 weeks of the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery. | 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. | Baseline, 3 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores. | The MAIA is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. Higher scores on each subscale indicate higher levels of interoceptive awareness.There are no standard normal values for each MAIA sub-scale; the range in previous samples from our group for the Not Distracting Score was 1-14. ; MAIA: Not Worrying Score 4-13; MAIA: Attention Regulation Score 4-35; MAIA: Emotional Awareness Score 5-25; MAIA: Self-Regulation Score 4-20; MAIA: Body Listening Score 1-15; MAIA: Trusting Score 3-15. | Baseline, 3 months, 9 months | 
| Change in average Heart Failure (HF) Self-Care total scores. | The Self-care of HF Index (SCHFI) v.7.2., is a psychometrically valid, self-report instrument with three separate scales: Self-Care Maintenance (which captures treatment adherence and healthy behaviors), Symptom Perception (which assesses the ability to detect and interpret physical symptoms), and Self-Care Management (the response to symptoms when they occur). Reliability is > 0.70 and scores range from 0 to 100; higher scores indicate better self-care. | Baseline, 3 months, 9 months | 
| Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS). | The HADS is a self-reported measure with two sub-scales (scores 0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity. A good correlation has been reported between the HADS and other commonly used measures of depression. The HADS has been validated in cardiac patients. | Baseline, 3 months, 9 months | 
| Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) quantifies HF-specific physical limitations, symptom frequency, severity and change over time, overall quality of life, social interference, and knowledge. Responses are scored on a Likert scale and summed. Higher scores indicate higher quality of life. Construct validity and sensitivity of the KCCQ have been demonstrated. | Baseline, 3 months, 9 months | 
| Change in high frequency power heart rate variability (hf-HRV) in Ln msec2. | High-frequency band is an index of cardiovagal control. High frequency power (hf-HRV) in Ln msec2 , a demonstrated index of vagal activity, will be determined by averaging high frequency values for 10 minute segments at each visit. The proposed methods are based on standards established in the literature. | Baseline, 3 months, 9 months | 
| Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels. | NT-proBNP is a marker of HF disease severity, elevated filling pressures, clinical outcomes, and is responsive to interventions (e.g., exercise). Specimens are collected in a plastic EDTA tube , centrifuged and separated plasma samples are stored at -20°C until testing. Assays will be analyzed using the ADVIA Centaur BNP assay, a fully automated two-site sandwich immunoassay using direct chemiluminescent technology . The ADVIA Centaur BNP assay measures BNP concentrations up to 5000 pg/mL with a minimum detectable concentration (analytical sensitivity) of < 2.0 pg/mL and shows high specificity for BNP. | Baseline, 3 months, 9 months | 
| Change in average 6-min walk test (6MWT) distance. | The 6MWT measures the distance a patient can walk on a level course in 6 min. It is a measure of functional capacity that correlates with peak oxygen uptake and is positively associated with survival in patients with cardiovascular disease. A higher value (in meters) indicates better functional capacity. The 6MWT distance in healthy adults has been reported to range from 400 to 700 meters. | Baseline, 3 months, 9 months |