Mindfulness Training + Enhanced Usual Care for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Miriam Hospital, Providence, RI
Heart Failure+2 More
Mindfulness Training + Enhanced Usual Care - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions

  • Heart Failure
  • Cognitive Impairment (CI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: Baseline, 3 months, 9 months

9 months
HF hospital readmissions
Month 9
B-type natriuretic peptide (BNP)
Cardiac Vagal Control
Change in B-type natriuretic peptide (BNP) levels.
Change in average 6-min walk test (6MWT) distance.
Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
Change in average Heart Failure (HF) Self-Care total scores.
Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.
Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.
Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.
Cognitive Function
Functional capacity
Health-related Quality of Life
Heart failure self-care
Interoceptive awareness
Mood

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Mindful Training + Enhanced Usual Care
1 of 1
Experimental Treatment

176 Total Participants · 1 Treatment Group

Primary Treatment: Mindfulness Training + Enhanced Usual Care · No Placebo Group · N/A

Mindful Training + Enhanced Usual Care
Behavioral
Experimental Group · 1 Intervention: Mindfulness Training + Enhanced Usual Care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 9 months
Closest Location: The Miriam Hospital · Providence, RI
Photo of rhode island 1Photo of rhode island 2Photo of rhode island 3
1999First Recorded Clinical Trial
5 TrialsResearching Heart Failure
141 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,348 Previous Clinical Trials
3,261,721 Total Patients Enrolled
32 Trials studying Heart Failure
211,434 Patients Enrolled for Heart Failure
The Miriam HospitalLead Sponsor
225 Previous Clinical Trials
36,028 Total Patients Enrolled
3 Trials studying Heart Failure
63 Patients Enrolled for Heart Failure
Elena Salmoirago-Blotcher, MD, PhDPrincipal InvestigatorCardiovascular Institute, The Miriam Hospital, Brown University
3 Previous Clinical Trials
189 Total Patients Enrolled
1 Trials studying Heart Failure
33 Patients Enrolled for Heart Failure

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have access to a telephone.
You have a documented diagnosis of heart failure.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.