Mind Your Heart-II

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Miriam Hospital

About this trial

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years old

A documented diagnosis of HF

Access to a telephone

Mild cognitive impairment (MoCA score < = 26)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness Training + Enhanced Usual Care

    Behavioral

    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.

  • Enhanced Usual Care

    Other intervention

    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.

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: Mindful Training + Enhanced Usual CareExperimental treatment 1 intervention
Group B: Enhanced Usual Care aloneOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3 months, 9 months

Secondary outcomes

1

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.

Time frame
Baseline, 3 months, 9 months
2

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.

Time frame
Baseline, 3 months, 9 months
3

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.

Time frame
Baseline, 3 months, 9 months
4

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.

Time frame
Baseline, 3 months, 9 months

Other outcomes

1

HF hospital readmissions

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.

Time frame
9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Miriam Hospital

Lead sponsor

National Institute on Aging (NIA)

Collaborator