N/A
Completed N=10
The Care After Life-threatening Medical Events Study
Source: ClinicalTrials.gov NCT04589559 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Percentage of Eligible Cardiac Arrest (CA) Survivors Whom we Approach Who Ultimately Agree to Participate in the Pilot Study — 83.33 percentage of participants who enrolled
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eligible Cardiac Arrest (CA) Survivors Whom we Approach Who Ultimately Agree to Participate in the Pilot Study |
83.33 | — |
| SECONDARY Percentage of Enrolled Participants Who Complete the Pilot Study |
100.0 | — |
| SECONDARY Percentage of Participants Who Complete a Majority of the At-home HRVB Sessions for the Pilot Study |
60.00 | — |
| SECONDARY Percentage of Participants Who Report Adequate Feasibility |
90.00 | — |
| SECONDARY Percentage of Participants Who Report Adequate Acceptability |
90.00 | — |
| SECONDARY Percentage of Participants Who Report Adequate Appropriateness |
80.00 | — |
| SECONDARY Percentage of Participants Who Report Adequate Usability |
80.00 | — |
| SECONDARY Visit-2-to-3 Change in Cardiac-related Interoceptive Fear |
-1.50 | 0.152 |
| SECONDARY Visit-2-to-3 Change in Trait Anxiety |
-6.20 | 0.031 sig |
| SECONDARY Visit-2-to-3 Change in Trait Negative Affect |
-1.90 | 0.323 |
| SECONDARY Heart Rate Variability (HRV) |
0.58 | 0.112 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04589559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.