The Miriam Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT05431192
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Baseline, 3 months, 9 months
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.
Time frame: Baseline, 3 months, 9 months
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.
Time frame: Baseline, 3 months, 9 months
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.
Time frame: Baseline, 3 months, 9 months
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.
Time frame: Baseline, 3 months, 9 months
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.
Time frame: Baseline, 3 months, 9 months
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.
Time frame: Baseline, 3 months, 9 months
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.
Time frame: 9 months
Proportion of patients admitted to the hospital with a diagnosis of HF. HF hospital admissions will be tracked via EMR and direct inquiry with participants.
The Miriam Hospital
Other
Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.
Acronym: MYH-II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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