The Care After Life-threatening Medical Events Study

NCT04589559 | Completed Results

• 2 other identifiers: AAAS9001P30AG064198
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest; Fear

Keywords

Cardiac arrest; Fear; Psychological distress; Heart Rate Variability Biofeedback

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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)

Study Arms (1)

Intervention: Heart Rate Variability Biofeedback

EXPERIMENTAL

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.

Behavioral: Heart Rate Variability Biofeedback Training

Interventions

Heart Rate Variability Biofeedback Training BEHAVIORAL

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.

Also known as: HRV Biofeedback

Intervention: Heart Rate Variability Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Fluent in English
• A diagnosis of cardiac arrest (CA)
• Time elapsed since their CA is less than 72 months
• Elevated post-traumatic stress disorder (PTSD) symptom total scores on the 17-item Post-Traumatic Stress Disorder Checklist (PCL) of 30 or higher (i.e., greater than the median in a prior sample of cardiac arrest survivors) or elevated PCL-5 scores of 30 or higher or Acute Stress Disorder Scale (ASDS) scores of 34 or higher
• Owns either an iPhone or Android smartphone in order to run the app involved in the intervention

You may not qualify if:

• Breathing difficulty that does not allow participant to complete the intervention
• Inability to comply with the protocol (either self-selected or indicated during screening that s/he could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia and patients with current alcohol or substance abuse, and patients with severe mental illness (e.g., schizophrenia).

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Jeffrey Birk
• Organization: Columbia University Irving Medical Center

jlb2287@cumc.columbia.edu

212-342-5503

Study Officials

• Jeffrey L Birk, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medical Sciences

Model Details: The intervention involves heart rate variability biofeedback (HRVB) administered via a smartphone app (Elite HRV) that receives real-time cardiac information from a chest-worn heart rate monitor (Polar H10).

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 19, 2020
• Study Start: November 23, 2020
• Primary Completion: July 23, 2021
• Study Completion: July 23, 2021
• Last Updated: August 19, 2022
• Results First Posted: August 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)