Evidence map›Paper›PMID 36682491›Full record

ArticleContemporary clinical trials2023

Mind Your Heart-II: Protocol for a behavioral randomized controlled trial of mindfulness training to promote self-care in patients with comorbid heart failure and cognitive impairment.

Natalie G Keirns, Sara Ouaddi, Shira Dunsiger, Giulia Locatelli, Emily C Gathright, Emma Black, Janice Tripolone, Christopher Breault, Barbara Riegel, Ronald Cohen and 1 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.6field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 3 countries.

Natalie G KeirnsDepartment of Psychiatry and Human Behavior, Warren Alpert School of Medicine, Brown University, Providence, RI, USA; Department of Psychology, Oklahoma State University, Stillwater, OK, USA. Electronic address: natalie_keirns@brown.edu.
Sara OuaddiCenter for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.
Shira DunsigerCenter for Health Promotion and Health Equity, Department of Behavioral and Social Science, School of Public Health, Brown University, Providence, RI, USA.
Giulia LocatelliDepartment of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy; School of Nursing, Midwifery and Paramedicine, Faculty of Health Sciences, Australian Catholic University, Melbourne, Australia.
Emily C GathrightDepartment of Psychiatry and Human Behavior, Warren Alpert School of Medicine, Brown University, Providence, RI, USA; Center for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.
Emma BlackCenter for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.
Janice TripoloneCenter for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.
Christopher BreaultCenter for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.
Barbara RiegelUniversity of Pennsylvania, School of Nursing, Philadelphia, PA, USA; Australian Catholic University, Mary MacKillop Institute for Health Research, Melbourne, Australia; Center for Home Care Policy & Research at VNS Health, New York, NY, USA.
Ronald CohenCognitive Aging and Memory Program, McKnight Institute on Aging, University of Florida, Gainesville, FL, USA.
Elena Salmoirago-BlotcherDepartment of Psychiatry and Human Behavior, Warren Alpert School of Medicine, Brown University, Providence, RI, USA; Lifespan Cardiovascular Institute, The Miriam Hospital, Providence, RI, USA; Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.
Miriam Hospital · USBrown University · USOklahoma State University · USUniversity of Florida · USUniversity of Rome Tor Vergata · ITVNS Health · US

Funding

Targeting cognitive function and interoceptive awareness to improve self-management in patients with co-morbid heart failure and cognitive impairment.R01AG076438 · NIA · MIRIAM HOSPITAL · PI Elena Salmoirago-Blotcher · 2022 to 2026
$3.4M
Stress and resilience in women with Takotsubo syndrome: Admin SupplementR01HL149672 · NHLBI · MIRIAM HOSPITAL · PI SALMOIRAGO-BLOTCHER, ELENA · 2020 to 2024
$2.9M
Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in ACS SurvivorsR01AT012072 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SALMOIRAGO-BLOTCHER, ELENA, YEH, GLORIA Y · 2022 to 2025
$1.7M
Development of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults with Heart Failure Completing Cardiac RehabilitationK23AG061214 · NIA · MIRIAM HOSPITAL · PI GATHRIGHT, EMILY CLAIRE · 2019 to 2023
$1.0M
NCCIH NIH HHS R01 AT012072NHLBI NIH HHS R01 HL149672NIA NIH HHS K23 AG061214NIA NIH HHS R01 AG076438
6 · The paper itself

Abstract

backgroundHeart failure (HF) self-care is a robust predictor of prognosis in HF patients. Cognitive impairment is a common comorbidity in HF patients and constitutes a major challenge to HF self-care. Mindfulness training (MT) has been shown to improve cognitive function and interoception, two components essential to promoting effective HF self-care.

objectivesThe aims of the Mind Your Heart-II (MYH-II) study are to investigate the effects of MT on HF self-care via changes in cognitive function and interoception in patients with comorbid HF and cognitive impairment, and to study the process by which MT can improve cognitive function via vagal control. We hypothesize that MT will improve cognitive function, interoception, and vagal control, resulting in enhanced HF self-care, compared to control participants.

methodsMYH-II is a mechanistic parallel phase II behavioral randomized controlled trial. We will enroll 176 English or Spanish-speaking patients with comorbid chronic HF and mild cognitive impairment. Participants will be randomized to either: (1) 8-week phone-delivered MT + Enhanced Usual Care (EUC), or (2) EUC alone. Participants will complete baseline, end-of-treatment (3 months), and follow-up (9 months) assessments. The primary outcome is cognitive function (NIH Toolbox Fluid Cognition Composite Score). Additional key outcomes include: interoception (heartbeat tracking task, Multidimensional Assessment of Interoceptive Awareness), HF self-care (Self-Care of Heart Failure Index v7.2), and vagal control (high-frequency heart rate variability). IMPLICATIONS: If study hypotheses are confirmed, phone-based MT may be a key tool for improving HF self-care, and possibly clinical outcomes, in HF patients with comorbid cognitive impairment.

Indexed as

Cognitive DysfunctionHeart FailureMindfulnessClinical Trials, Phase II as TopicComorbidityHumansRandomized Controlled Trials as TopicSelf CareTreatment OutcomeCognitive impairmentHeart failureInteroceptionMindfulness trainingSelf-care

Identifiers

PMID36682491
PMCPMC10026453
OpenAlexW4317624875

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.