Post Intensive Care Accelerometery to Study and Support Recovery Outcomes (NCT07466446) | Clinical Trial Compass
RecruitingNot Applicable
Post Intensive Care Accelerometery to Study and Support Recovery Outcomes
United Kingdom40 participantsStarted 2026-03-30
Plain-language summary
The primary purpose of this study is to find out whether a wrist-worn activity monitor can help healthcare professionals understand how people recover after they leave the intensive care unit (ICU), where they were cared for when they were most unwell. By tracking recovery at home, the device may help identify problems early so that the right support can be provided. The study involves adults who are discharged from the ICU in three hospitals in Edinburgh.
The main questions it aims to answer are:
* Can movement data from a wearable device give useful information about how people feel and function after they return home following ICU and then hospital discharge?
* Do changes in activity levels relate to changes in symptoms like pain, anxiety or behavioural measures like daily functioning, sleep and cognition? There is no comparison group in this study.
Participants will:
* Wear a wrist-worn activity monitor
* Answer a short set of health-related questionnaires
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:
* Adults aged 18 years or older
* Mechanical ventilation for more than 3 days
* Total ICU length of stay greater than 7 days
* Classified as "High Risk" using a validated High-Risk Tool\*
* Expected to be discharged from hospital within the next several days
Exclusion Criteria:
* Primary neurological diagnosis as the reason for ICU admission
* Identified by the clinical team as being on the palliative care pathway
* Physical activity primarily limited by the acute injury (e.g., major trauma or limb amputation)
* Unable to mobilise independently prior to the index hospitalisation requiring ICU admission due to a long-term condition and/or disability
* Lack of capacity or inability to provide informed consent
* The High-Risk Tool (Walsh et al., 2022) assesses eight domains: recent hospital admissions; multimorbidity (≥4 chronic conditions); polypharmacy (≥4 regular medications); prior mental health disorder; substance misuse history; current antidepressant or antipsychotic therapy; need for assistance with activities of daily living (ADLs); and living alone or fragile social circumstances. Patients meeting ≥3 domains are classified as high risk for post-ICU deterioration and readmission.
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.
1Since this study is focused on whether it's even feasible to collect wearable activity data after an ICU stay — rather than testing a treatment — what would actually be expected of me as a participant, like wearing a device and for how long?
2Post Intensive Care Syndrome can affect people differently after an ICU stay — would my doctor think my specific recovery situation is a good fit for what this study is trying to measure?
3Since this is a feasibility study and not a phase that's testing a new therapy, would participating in this trial replace or run alongside whatever recovery care or rehabilitation my doctor would already recommend for PICS?
4How might wearing an accelerometer and having my activity tracked actually benefit my care, or is the data mainly being collected to help researchers design future studies?
5Given that I'm still recovering from an intensive care stay, are there any physical or logistical demands of participating — like follow-up visits or data reporting requirements — that my doctor thinks I should weigh against my current energy and health status?
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.