Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Individually tailored rehabilitation intervention, Usual care.
- Кому может быть актуально
- Состояния в реестре: Cardiac Arrest, Heart Arrest, Cardiopulmonary Resuscitation, Return to Work. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The ROCK Trial. A Multidisciplinary Rehabilitation Intervention Targeted Return-to-work in Sudden Out-of-hospital Cardiac Arrest Survivors A Pragmatic Randomised Controlled Trial
Обзор
This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA. Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation intervention focusing on supporting RTW plus usual care compared to usual care alone.
Подробное описание
The ROCK trial is a two-arm multicentre investigator-initiated clinical randomised controlled superiority trial evaluating the effectiveness of a comprehensive individually tailored rehabilitation intervention focusing on supporting labour marked participation of survivors of out-of-hospital cardiac arrest compared to usual care, with primary endpoint measured after 12 months follow-up.
The overall aim of the ROCK trial is to evaluate the effectiveness of a comprehensive individually tailored multidisciplinary rehabilitation intervention for survivors of OHCA on RTW compared to usual care. The investigators hypothesize that the intervention will result in a higher-level labour marked attachment one year after hospital discharge in addition to increased health-related quality of life.
A full statistical analysis plan describing all details have been developed. In short, data from the national register on social transfer payments (DREAM database) will form the basis for the primary outcome. The primary outcome is labour market participation, defined as the proportion of employment vs. on social transfer payment, and the primary end point will be collected 12 months after hospital discharge.
Вмешательства
- Другое Individually tailored rehabilitation intervention
Individually tailored rehabilitation intervention - Другое Usual care
Usual care
Первичные конечные точки
- Labour market participation using data from the DREAM database [Срок оценки: 12-months after hospital discharge]
Вторичные конечные точки (10)
- Return-to-work - Multi-state models of patients change in states from baseline to 12-months after hospital discharge [Срок оценки: 12-months after hospital discharge]
- PRO: Readiness for return-to-work (RRTW) [Срок оценки: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge]
- PRO: Degree of return-to-work [Срок оценки: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge]
- PROM: EQ-5D-5L [Срок оценки: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge]
- PROM: Multidimensional fatigue inventory (MFI-20) [Срок оценки: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge]
- PROM: The Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge]
- PROM: The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline (Hospital discharge), 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge]
- The Health Literacy Questionnaire (HLQ) [Срок оценки: 2 weeks, 26 weeks and 52 weeks after hospital discharge]
- PROM: Disease specific health-related quality of life (HeartQoL) [Срок оценки: 2 weeks, 12 weeks, 26 weeks and 52 weeks after hospital discharge]
- The Impact of Event Scale - Revised (IES-R) [Срок оценки: 12 weeks, 26 weeks and 52 weeks after hospital discharge]
Критерии участия
Критерии включения
- All adult survivors with first time out-of-hospital cardiac arrest
- Discharged from the Hospitals will be assessed eligible for inclusion
Критерии исключения
- Survivors who prior to the cardiac arrest were not part of the labour force with at least two years until they are qualified to receive retirement state pensions
- Patients that cannot understand and fulfil the study surveys (in Danish)
- Patients with short witnessed cardiac arrests with return of spontaneous circulation estimated less than 4 minutes and immediate awakening without ICU treatment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Rigshospitalet — Copenhagen
Публикации
- Christensen J, Winkel BG, Kirkeskov L, Folke F, Winther-Jensen M, Eckhardt-Bentsen C, Kjaergaard J, Hassager C, Wagner MK. The ROCK trial-a multidisciplinary Rehabilitation intervention for sudden Out-of-hospital Cardiac arrest survivors focusing on return-to-worK: a pragmatic randomized controlled trial protocol. Trials. 2024 Feb 1;25(1):99. doi: 10.1186/s13063-024-07911-6. PMID 38303019
Идентификаторы
NCT: NCT05173740 · H-20049654