Post Intensive Care Accelerometery to Study and Support Recovery Outcomes
ConditionPost Intensive Care Syndrome (PICS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Edinburgh
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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*
Disqualifiers
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
Trial population
Adults discharged from an intensive care unit and hospital who are at high risk of post-ICU syndrome and hospital readmission.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Feasibility of wearable data collection
The proportion of enrolled post-ICU patients achieving successful data collection. Successful data collection is defined as: * 16 hours of wear time within a 24-hour period and * 5 valid days per week for ≥ 3 of the 4 weeks during the two-month monitoring period.
Time frame
2 months after hospital dischargeSecondary outcomes
1
Telephone Questionnaire Completion Rate
The proportion of included post-ICU patients who successfully complete the battery of follow-up assessments, including the EQ-5D-5L, PSQI, T-MoCA, and PROMIS PF-10a questionnaires at the following time-frames: Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.
Time frame
2 months after hospital discharge2
Unplanned hospital readmission rate
The proportion of participants experiencing at least one unplanned hospital readmission following the index discharge.
Time frame
2 months after hospital discharge.3
All-cause mortality
The proportion of participants who die from any cause following index hospital discharge.
Time frame
2 months after hospital discharge.4
Health-Related Quality of Life (HRQoL)
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. This includes five domain scores (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression) ranging from 1 (no problems) to 5 (extreme problems), and the EQ Visual Analogue Scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame
Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.Sponsors and contacts
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Source ClinicalTrials.gov