Gamberini Lorenzo, Rucci Paola, Dolcini Camilla, Masi Martina, Simoncini Laura, Tartaglione Marco, Del Giudice Donatella, Domina Rosa, Fagiolini Andrea, Salucci Pamela
Department of Intensive Care and Prehospital Emergency, Emergency Department, Maggiore Hospital, Bologna, Italy.
Department of Biomedical and Neuromotor Sciences - University of Bologna, Italy.
Resusc Plus. 2024 Sep 18;20:100772. doi: 10.1016/j.resplu.2024.100772. eCollection 2024 Dec.
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.
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.
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).
院外心脏骤停（OHCA）是欧洲主要的健康问题，会导致严重的发病率和死亡率。幸存者常患有认知缺陷、焦虑和抑郁，严重影响他们的生活质量。目前出院后的护理并不一致，常常忽视细微但致残的症状。ENFORCER试验旨在通过提供全面、便捷且用户友好的基于互联网的生活方式干预措施，显著提高OHCA幸存者的健康水平和生活质量。
ENFORCER是一项多中心、平行组随机对照试验，纳入年龄在18至80岁之间、通过有效工具测量存在认知障碍或焦虑/抑郁的OHCA幸存者。参与者将按1:1随机分为干预组或对照组。干预组将通过安全的网络应用程序接受为期一年的项目，提供认知、情感和身体康复支持。对照组将接受标准护理。主要结局是一年后两组中无认知或情感症状患者比例的差异。次要结局包括两组患者认知和情感症状水平的变化、生活质量、睡眠质量、性兴趣和满意度，以及照顾者的负担、生活质量、睡眠质量和情感症状。
该试验满足了出院后持续护理以及及时发现和治疗认知与情感问题的需求。基于互联网的方法有可能惠及许多患者，确保成本效益和高依从率。研究结果可为OHCA后的护理建立标准，改善幸存者的长期康复和生活质量。试验注册。该试验已在clinicaltrials.gov（NCT06395558）注册。
