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Mindfulness Training
Mindfulness Training for Heart Failure (MYH-II Trial)
N/A
Recruiting
Led By Elena Salmoirago-Blotcher, MD, PhD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years old
A documented diagnosis of HF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 9 months
Awards & highlights
MYH-II Trial Summary
This trial will study if mindfulness training can help improve self-care among heart failure patients with cognitive impairment.
Who is the study for?
This trial is for adults over 18 with heart failure and mild cognitive issues who can speak English or Spanish. They must have a phone and not be planning to move during the study. People with severe mental health issues, enrolled in another study, or with very poor hearing or severe heart failure aren't eligible.Check my eligibility
What is being tested?
The trial examines if mindfulness training plus enhanced usual care helps patients manage their heart conditions better than just enhanced usual care alone. Participants will either receive this new combination of treatments or continue with their regular care.See study design
What are the potential side effects?
Mindfulness training is generally safe but may include temporary feelings of discomfort when dealing with emotions, fatigue from practice sessions, and potential frustration if no immediate improvement in self-care is noticed.
MYH-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have been diagnosed with heart failure.
MYH-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
Secondary outcome measures
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.
Change in average 6-min walk test (6MWT) distance.
Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).
+4 moreOther outcome measures
HF hospital readmissions
MYH-II Trial Design
2Treatment groups
Experimental Treatment
Group I: Mindful Training + Enhanced Usual CareExperimental Treatment1 Intervention
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
Group II: Enhanced Usual Care aloneExperimental Treatment1 Intervention
Usual care.
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Who is running the clinical trial?
The Miriam HospitalLead Sponsor
238 Previous Clinical Trials
37,299 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,887 Total Patients Enrolled
Elena Salmoirago-Blotcher, MD, PhDPrincipal InvestigatorCardiovascular Institute, The Miriam Hospital, Brown University
3 Previous Clinical Trials
189 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently practicing mind and body exercises at least once a month.I have not had thoughts of harming myself.You have a current mental or brain condition.You have mild problems with memory and thinking, as shown by a test score of 26 or lower.I am older than 18 years.I have been diagnosed with heart failure.I can understand and speak English or Spanish.You have significant problems with thinking and memory, as shown by a specific test score.You have very bad hearing and cannot hear phone calls.My heart condition is very severe or unstable.My heart failure is not caused by conditions like takotsubo or myocarditis.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care alone
- Group 2: Mindful Training + Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives is the research endeavor attempting to realize?
"The primary aim of this clinical trial, which is due to be assessed at Baseline, 3 months and 9 month intervals, is a Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery. Secondary goals will include an analysis of Health-related Quality of Life through the Kansas City Cardiomyopathy Questionnaire (KCCQ), Functional Capacity with a 6-min walk test (6MWT) distance measure, and Heart failure self-care evaluated by means of Self-care of HF Index (SCHFI)."
Answered by AI
Is this experiment still recruiting participants?
"As documented on clinicaltrials.gov, this particular trial is no longer admitting patients. This research initiative was initially published on October 1st 2022 and last edited on August 23rd 2022. Despite the conclusion of this experiment's enrolment period, there are 1310 other trials currently recruiting volunteers."
Answered by AI
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