ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial

Abstract

Background: Out-of-hospital cardiac arrest (OHCA) is a major health concern in Europe, leading to significant morbidity and mortality. Survivors often suffer from cognitive deficits, anxiety, and depression, that affect significantly their quality of life. Current post-discharge care is inconsistent and frequently overlooks subtle but disabling symptoms. The ENFORCER trial aims to significantly enhance the health and quality of life of OHCA survivors by providing a comprehensive, accessible, and user-friendly internet-based lifestyle intervention.

Methods: ENFORCER is a multicentre, parallel group randomized controlled trial involving OHCA survivors aged 18-80 years with cognitive impairment or anxiety/depression measured through validated instruments.Participants will be randomized 1:1 to the intervention or the control group. The intervention group will receive a one-year program via a secure web application, offering cognitive, emotional, and physical rehabilitation support. The control group will receive standard care.The primary outcome is the difference in the proportion of patients without cognitive or emotional symptoms between the two groups after one year.Secondary outcomes include changes in the level of patients' cognitive and emotional symptoms, quality of life, sleep quality, sexual interest and satisfaction, and caregivers' burden, quality of life, sleep quality and emotional symptoms in the two groups.

Discussion: The trial addresses the need for consistent post-discharge care, and the timely detection and treatment of cognitive and emotional problems. The internet-based approach allows to potentially reach many patients, ensuring cost-effectiveness and high adherence rates.The study results could establish a standard for post-OHCA care, improving long-term recovery and quality of life for survivors.Trial registration.The trial is registered at clinicaltrials.gov (NCT06395558).

Keywords: Anxiety; Cognitive dysfunction; Depression; Follow-up studies; Internet-based intervention; Out-of-Hospital Cardiac Arrest; Randomized controlled trial; Survivors.

Fig. 1

Patients’ flow through the study. Abbreviations: HADS – Hospital Anxiety and Depression Scale, TICS – Telephone Interview for Cognitive Status. Notes: patients not fulfilling the inclusion criteria for HADS or TICS will have their data kept for secondary analyses of the factors associated with anxiety and depression in OHCA survivors with good neurological recovery.