NCT04589559|CompletedResults
The Care After Life-threatening Medical Events Study
CALME
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CALME
Sponsor study identifier
Secondary identifiers
NIH
interventional
10
1 country
1
Study Start
November 23, 2020
Actual (reported)Primary Completion
July 23, 2021
Actual (reported)Study Completion
July 23, 2021
Actual (reported)This study tests the feasibility of a home-based heart rate variability biofeedback (HRVB) intervention in survivors of cardiac arrest (CA). Specifically, the primary purpose of this pilot study is to assess feasibility, acceptability, appropriateness, usability, and compliance for an at-home, 3-week HRVB intervention in 10 participants. The study also tests whether cardiac-related interoceptive fear, trait anxiety, and negative affect decrease among CA survivors completing the HRVB intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 23, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2020
Actual (reported)October 19, 2020
Actual (reported)November 23, 2020
Actual (reported)July 23, 2021
Actual (reported)July 23, 2021
Actual (reported)August 19, 2022
Actual (reported)Percentage of Eligible Cardiac Arrest (CA) Survivors Whom we Approach Who Ultimately Agree to Participate in the Pilot Study
This is to assess the feasibility of enrollment in the trial. The denominator for this metric is the number of potential participants who were approached and contacted by the study team who were determined to be eligible for the study. The numerator is the number of participants who enrolled in the study (i.e., 10 participants).
Baseline/Visit 1
Percentage of Enrolled Participants Who Complete the Pilot Study
Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Percentage of Participants Who Complete a Majority of the At-home HRVB Sessions for the Pilot Study
Pre-training/Visit 2, Post-training/Visit 3 (approximately 3 weeks apart)
Percentage of Participants Who Report Adequate Feasibility
Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Acceptability
Post-training/Visit 3 (approximately 3 weeks)
Percentage of Participants Who Report Adequate Appropriateness
Post-training/Visit 3 (approximately 3 weeks)
Participants in this intervention group complete at-home heart rate variability biofeedback (HRVB) training using a chest-worn heart rate monitor and a smartphone app. They complete at least 10 minutes per day of HRVB training on at least 5 days per week for 3 weeks.
First, participants are taught how to do relaxed, abdominal breathing. Second, they are taught how to breathe at a slow rate of 0.1 Hz (i.e., one completed breath cycle every 10 seconds). Third, they are taught how to monitor their heart rate variability (HRV) in real time using the smartphone app, which receives data wirelessly via Bluetooth from the heart rate monitor. Participants are instructed that their goal is to increase their HRV during the three weeks of at-home practice.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Columbia University Irving Medical Center
New York, New York, 10032, United States
Jeffrey L Birk, PhD
Columbia University
10 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2020
First Posted
October 19, 2020
Study Start
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Contact the study team to confirm eligibility.
November 23, 2020
Primary Completion
July 23, 2021
Actual (reported)Study Completion
July 23, 2021
Actual (reported)Last Updated
August 19, 2022
Results First Posted
August 19, 2022
Record last verified: 2022-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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