Remote multicomponent rehabilitation compared to standard care for survivors of critical illness after hospital discharge: a randomised controlled assessor-blind clinical and cost-effectiveness trial with internal pilot (iRehab)

Research question What is the clinical and cost effectiveness of a remote multicomponent rehabilitation intervention compared to standard care in survivors of critical illness following discharge home? Background The consequences of critical illness can be substantial and multifactorial, encompassing physical deconditioning, mental health impairments, fatigue, and declines in health-related quality of life. Aims and objectives Primary: To investigate, in survivors of critical illness following discharge from Intensive Care Units (ICU), the effects of a six week remote multicomponent rehabilitation intervention compared to standard care on quality of life at eight weeks post randomisation Secondary a) To investigate the effects of a six week remote multicomponent rehabilitation intervention compared to standard care on physical function, illness perception, fatigue, anxiety, and adverse events at eight weeks b) To investigate longer term effects of six week remote multicomponent rehabilitation programme compared to standard care on quality of life, physical function, illness perception, fatigue, and anxiety at six months c) To determine explanatory factors influencing outcomes via process evaluation d) To evaluate the cost-effectiveness of the rehabilitation intervention Methods Design: A pragmatic, randomised controlled, open-label, assessor blind, multi-centre, clinical and cost effectiveness trial with internal pilot Setting: Remote delivery via online video or phone in patients’ homes Population: Adults (n=428) discharged home from hospital following critical illness Inclusion: 1. Adults aged =18 years; 2. ICU admission requiring invasive mechanical ventilation =48hours; 3. Less than 12 weeks post hospital discharge; 4. Willing and able to participate in the programme Exclusion: 1. Declined consent or unable to give consent; 2. Participation in existing structured rehabilitation programme due to ongoing chronic disease Health technologies being assessed Rehabilitation intervention: Remote multi-component, individualised, rehabilitation intervention comprising: 1.Weekly guidance regarding symptom management; 2.Targeted exercise; 3.Support for psychological wellbeing; 4.Information provision and peer support. Standard care: no specific formal rehabilitation programme for patients post critical illness. Outcome measures: Assessor blind assessment (baseline, 8 weeks and 6 months), with parallel process evaluation and health economic analysis. Primary: Quality of Life – EQ-5D-5L Secondary Physical Function- 30 second sit to stand test Illness Perception - The Brief Illness Perception Questionnaire Fatigue- Functional Assessment of Chronic Illness Therapy– Fatigue Anxiety and Depression - Hospital Anxiety and Depression Scale Healthcare and social care utilisation questionnaire Safety-Adverse Events/Serious Adverse Events Timelines: Total: 36 months. Set-up 6months; 18 months recruitment based on 30 sites recruiting an average of 0.8 patients/site/month, follow-up six months post randomisation, final six months for final analysis and reporting. Anticipated impact and dissemination: This trial provides an opportunity to test a rehabilitation intervention for survivors of critical illness designed for everyone in the UK who could benefit. Dissemination will include publication in high impact factor journals, conference presentations, and circulation via relevant professional, patient and family networks