Post Intensive Care Accelerometery to Study and Support Recovery Outcomes

NCT07466446 | Recruiting

• 2 other identifiers: AC2522415096009
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Post Intensive Care Syndrome (PICS)

Keywords

Critical Illness; Post-Intensive Care Syndrome; Rehabilitation; Activities of Daily Living; Cognitive Dysfunction; Patient Reported Outcome Measures; Wearable Electronic Devices; Accelerometry; Physical Function; Quality of Life; Mobility; Self-Care; Pain; Anxiety

Outcome Measures

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.

  2 months after hospital discharge

Secondary Outcomes (7)

• Telephone Questionnaire Completion Rate

  2 months after hospital discharge

• Unplanned hospital readmission rate

  2 months after hospital discharge.

• All-cause mortality

  2 months after hospital discharge.

• Health-Related Quality of Life (HRQoL)

  Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.

• Sleep Quality

  Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults discharged from an intensive care unit and hospital who are at high risk of post-ICU syndrome and hospital readmission.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (3)

The Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

St Johns Hospital

Livingston, EH54 6PP, United Kingdom

RECRUITING

Related Publications (4)

• Public Health Scotland, Scottish Intensive Care Society Audit Group, 2024. Audit of Critical Care in Scotland 2024: Reporting on 2023. Public Health Scotland, Edinburgh

  BACKGROUND

• Walsh TS, Pauley E, Donaghy E, Thompson J, Barclay L, Parker RA, Weir C, Marple J. Does a screening checklist for complex health and social care needs have potential clinical usefulness for predicting unplanned hospital readmissions in intensive care survivors: development and prospective cohort study. BMJ Open. 2022 Mar 23;12(3):e056524. doi: 10.1136/bmjopen-2021-056524.

  PMID: 35321894 BACKGROUND

• Tsanas A. Investigating Wrist-Based Acceleration Summary Measures across Different Sample Rates towards 24-Hour Physical Activity and Sleep Profile Assessment. Sensors (Basel). 2022 Aug 17;22(16):6152. doi: 10.3390/s22166152.

  PMID: 36015910 BACKGROUND

• National Confidential Enquiry into Patient Outcome and Death (NCEPOD), 2025. Recovery Beyond Survival: A review of the quality of rehabilitation care provided to patients following an admission to an intensive care unit. National Confidential Enquiry into Patient Outcome and Death, London.

  BACKGROUND

MeSH Terms

Conditions

postintensive care syndrome; Critical Illness; Cognitive Dysfunction; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Zoeb Jiwaji, Dr

CONTACT

0044 (0)131 242 1186; zoeb.jiwaji@ed.ac.uk

Barat Ospanov, Dr

CONTACT

b.ospanov@sms.ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 12, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): July 3, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

GB (3)