The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience

Post-cardiac arrest mortality remains high and proper care after cardiopulmonary resuscitation is an important clinical challenge. This prospective observational cohort aims to (1) identify the factors that affect short-term and long-term survival in post-cardiac arrest survivors and (2) investigate the patients and their families' health-related quality of life and psychological well-being.

Study Overview

• Status: Recruiting
• Conditions: Post-Cardiac Arrest Syndrome

Detailed Description

For this cohort study, adult survivors (≧20 years) of sudden cardiac arrest for more than 5 minutes after cardiopulmonary resuscitation will be enrolled. Basic demographic information, clinical events throughout hospitalization, and laboratory examination results will be recorded. Patients will be assessed for their neurological outcome using Glasgow coma score (GCS) and cerebral performance categories (CPC) upon hospital discharge, 1, 3, 6, and 12 months after discharge.

Post-cardiac arrest care is clinically challenging and this study aims to evaluate not just the physical well-being but also the psychological well-being of these patients on the short-term and long-term survival. Patients and their families will be assessed on their health-related quality of life and psychological well-being upon hospital discharge using the following scales: Mayo-Portland Adaptability Inventory (MPAI-4), World Health Organization Quality of Life Scale (WHOQOL-BREF), Impact of Event Scale - Revised (IES-R), and Family Resilience Framework. They will also be followed for one year after discharge at 1, 3, 6, and 12 months.

Data will be analyzed using the SPSS and SAS package. Odds ratios and hazards ratios will be determined for the factors that affect survival after cardiac arrest. The findings will help clinicians provide timely support to the patients and their families to promote physical and psychological well-being, and integrate them back to society as soon as possible.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Min-Shan Tsai, MD, PhD; Phone Number: 886-2-23562831; Email: mshanmshan@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chien-Hua Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The primary participants of the study are patients with out-of-hospital cardiac arrest and achieved return of spontaneous circulation after cardiopulmonary resuscitation. The number of primary participants is 200, and the interviewees are patients and their family members (400), a total of 600 participants.

Description

Inclusion Criteria:

1. Patients with non-traumatic cardiac arrest, who have successfully sustained return of spontaneous circulation for more than five minutes after resuscitation efforts.

Exclusion Criteria:

1. Under 20 years of age
2. Pregnant
3. Terminally ill cancer patients or cancer patients who are unwilling to receive treatment
4. When the ICU is over capacity and unable to provide intensive care.
5. The patient or family members refused to participate in this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-cardiac arrest survival	Post-cardiac arrest survival after cardiopulmonary resuscitation	Up to 1 year after discharge
Neurological outcome - GCS	Using the Glasgow Coma Scale (GCS) of the patients, with scores ranging from 3 to 15, and higher scores indicating a better outcome.	Up to 1 year after discharge
Neurological outcome - CPC	Cerebral performance categories (CPC) of the patients, with categories 1 and 2 as favorable outcomes, and categories 3 to 5 as unfavorable outcomes	Up to 1 year after discharge
Functional outcome	Self-reported assessment using the Mayo-Portland Adaptability Index (MPAI-4) for the patients. This is a 29-item scale with overall scores ranging from 0 to 111, and lower scores indicating a better outcome and greater community reintegration post-injury.	Up to 1 year after discharge
Life quality	Self-reported assessment using the abbreviated World Health Organization Quality of Life questionnaire (WHOQOL-BREF) for the patients. This is a 26-item scale with overall transformed scores ranging from 0 to 100, and higher scores indicating a better quality of life.	Up to 1 year after discharge
Emotional stress	Self-reported assessment using the Impact of Events Scale - Revised (IES-R) for the patients. This is a 22-item scale with scores ranging from 0 to 88, and higher scores indicating more subjective distress.	Up to 1 year after discharge
Family resilience	Self-reported assessment using the Family Resilience Framework scale for the patients and their families. This is a 31-item scale with scores ranging from 0 to 155, and higher scores indicating a higher level of resilience.	Up to 1 year after discharge

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Min-Shan Tsai, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Holistic care; Post-cardiac arrest; Family resilience
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Heart Diseases; Brain Injuries; Reperfusion Injury; Post-Cardiac Arrest Syndrome; Heart Arrest
• Other Study ID Numbers: 202012242RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No