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NCT02722213 · ClinicalTrials.gov registry record · NA
Mindfulness & Stress Management Study for Cardiac Patients
A NA study of Heart Failure and Heart Diseases, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT02722213: Completed NA study of Heart Failure and Heart Diseases, sponsored by University of Minnesota.
NCT02722213 is a NA study of Heart Failure and Heart Diseases that has completed, run by University of Minnesota. The registered enrollment target is 47 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02722213, a NA study of Heart Failure and Heart Diseases, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
The guideline-recommended standard of care for patients who have experienced a heart attack, heart failure, or other coronary event or procedure is exercise-based cardiac rehabilitation (CR). Despite proven benefits, traditional CR is severely underutilized. Moreover, what is typically lacking from traditional CR programs is effective psychosocial risk management. This represents a critical gap in care given the well-documented psychosocial needs of this patient population.The objective of this feasibility study is to conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Stress Reduction (MBSR) versus usual care in CR-eligible cardiac patients. Randomization will be stratified within two strata based on participation in CR (yes/no) among CR-eligible patients. The primary goals of this pilot study are to: 1) obtain estimates of treatment effects and variability; 2) evaluate recruitment and retention strategies; and 3) examine the safety of the MBSR protocol in CR-eligible patients.
Primary Outcome
Time domain and frequency domain variables will be assessed via 24-hour Holter monitoring at baseline, 3-month follow-up and 9-month follow-up. HRV is a well-established method to assess the autonomic nervous system, and has been shown to be a predictor of hard outcomes in cardiac patients. Given the deranged autonomic milieu in these patients, HRV is an appropriate surrogate end point for improved outcomes in this cohort.
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based Stress Reduction (MBSR).
Study Locations (1)
Minnesota
- University of Minnesota Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2016-05 |
| Est. Completion | 2017-08 |
| Phase | NA |
What the finished NCT02722213 record still lists
NCT02722213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower).
The record links to 6 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Mindfulness-Based Stress Reduction (MBSR). is the first listed.
NCT02722213 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02722213 about?
NCT02722213 is a clinical study titled "Mindfulness & Stress Management Study for Cardiac Patients". The guideline-recommended standard of care for patients who have experienced a heart attack, heart failure, or other coronary event or procedure is exercise-based cardiac rehabilitation (CR). Despite proven benefits, traditional CR is severely underutilized. Moreover, what is typically lacking from ...
What is the current status of trial NCT02722213?
This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2016-05. Estimated completion is 2017-08.
What conditions does trial NCT02722213 study?
This clinical trial studies the following conditions: Heart Failure, Heart Diseases, Myocardial Infarction, Coronary Artery Bypass, Chronic Stable Angina.
What interventions are being tested in trial NCT02722213?
The interventions under investigation include: Mindfulness-Based Stress Reduction (MBSR). (BEHAVIORAL).
Who is sponsoring clinical trial NCT02722213?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02722213 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02722213's enrollment target sits among peer trials
47 295th of 397 higher than 102 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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