Combined Activity and Cognitive Intervention for ICU Survivors (NCT06117761) | Clinical Trial Compass
UnknownNot Applicable
Combined Activity and Cognitive Intervention for ICU Survivors
Hong Kong60 participantsStarted 2023-12-01
Plain-language summary
This mixed-methods study comprising a 3-arm pilot RCT and a qualitative study aims to investigate the preliminary effects and feasibility of a home-based combined activity and cognitive intervention for ICU survivors (COMBAT-ICU). Adopting a 3-arm design with COMBAT-ICU, exercise and attention placebo study arms will enable us to evaluate the added effects, if any, of the novel combined intervention compared with the standard exercise-only rehabilitation strategy and attention placebo. Data triangulation from quantitative and qualitative aspects can facilitate result interpretation. The study's objectives are:
1. To evaluate the preliminary effects of the COMBAT-ICU intervention for ICU survivors on PICS, physical, mental and cognitive outcomes, HRQoL, unplanned re-hospitalisation rate, and mortality.
2. To explore the feasibility and acceptability of the COMBAT-ICU intervention and ICU survivors' intervention engagement experience.
The hypothesis of the first objective is that upon completion of the COMBAT-ICU intervention, ICU survivors will have reduced PICS, improved physical function, mental health, cognition and HRQoL, and reduced unplanned readmissions and mortality compared with the exercise and attention placebo groups at post-intervention and 3 months thereafter. While the hypothesis of the second objective is that the COMBAT-ICU intervention is feasible and acceptable for ICU survivors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Chinese adults aged ≥18
. has been admitted to ICU for at least 4 days
. discharged home
. able to perform basic activities of daily living before ICU admission
. living with family
. has an electronic device that can access the internet (patient/family)
. able to walk for at least 10 metres (assisted or unassisted)
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is targeting something called Post Intensive Care Syndrome — if I've been in the ICU and experienced delirium, muscle weakness, or cognitive problems after, would my doctor think I fit the kind of patient this study is designed for?
2The trial combines both a physical activity program and a cognitive intervention for ICU survivors — can my doctor explain what that kind of combined approach would actually involve day-to-day, and whether my current physical and mental state could handle both components?
3Since the recruitment status for this trial is listed as 'unknown,' can my doctor help find out whether the study is still actively enrolling patients or whether it has paused or closed?
4This study measures outcomes based on what patients themselves report about their Post Intensive Care Syndrome — how does my doctor feel about whether my own sense of how I'm recovering is a reliable way to track progress, and what does that mean for how my care would be evaluated?
5Before considering this trial, should I ask my doctor whether there are standard rehabilitation or cognitive therapy programs already available that treat these same ICU-related problems, and how those might compare to joining a research study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-reported PICS
Timeframe: At baseline (T0), immediate post-intervention: 8 weeks (T1) and 3 months post-intervention (T2)
. has musculoskeletal injury precluding exercise training
. is receiving structured out-patient pulmonary or cardiac rehabilitation after discharge
. has clinically evident dementia or significant impairment from an acute brain problem (e.g. traumatic brain injury, stroke, subarachnoid haemorrhage or hypoxic brain injury) that precludes following the study protocol
. has prolonged length of stay (≥28 days) in the step-down wards