ENFORCER，针对心脏骤停幸存者的互联网干预：随机、平行分组、多中心临床试验的研究方案

IF 2.1 Q3 CRITICAL CARE MEDICINE Resuscitation plus Pub Date : 2024-09-18 DOI:10.1016/j.resplu.2024.100772

Lorenzo Gamberini , Paola Rucci , Camilla Dolcini , Martina Masi , Laura Simoncini , Marco Tartaglione , Donatella Del Giudice , Rosa Domina , Andrea Fagiolini , Pamela Salucci , Collaborators

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引用次数: 0

摘要

背景院外心脏骤停（OHCA）是欧洲的一个主要健康问题，会导致严重的发病率和死亡率。幸存者通常会出现认知障碍、焦虑和抑郁，严重影响他们的生活质量。目前的出院后护理并不一致，经常会忽略一些细微但却令人丧失能力的症状。ENFORCER试验旨在通过提供一种全面、方便、易用的基于互联网的生活方式干预措施，显著提高心脏骤停患者的健康水平和生活质量。方法ENFORCER是一项多中心、平行组随机对照试验，参与试验的心脏骤停患者年龄在18-80岁之间，认知障碍或焦虑/抑郁程度通过有效工具进行测量。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。次要结果包括两组患者的认知和情绪症状水平、生活质量、睡眠质量、性兴趣和满意度的变化，以及护理人员的负担、生活质量、睡眠质量和情绪症状的变化。讨论该试验满足了出院后持续护理以及及时发现和治疗认知和情绪问题的需求。基于互联网的方法有可能使许多患者受益，确保了成本效益和高依从率。研究结果可为 OHCA 出院后护理建立一个标准，改善幸存者的长期康复和生活质量。

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

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).

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