Post Intensive Care Accelerometery to Study and Support Recovery Outcomes (PICASSO)

April 28, 2026 updated by: University of Edinburgh

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

Many people who survive a critical illness continue to face physical, emotional, and social challenges for a prolonged period afterwards. The Critical Care Recovery Service (CCRS) supports recovery across three acute hospitals in NHS Lothian, providing coordinated physical and psychological rehabilitation for ICU survivors. Within this diverse group, rehabilitation needs are graded as low or high risk using a validated screening checklist to identify patients with complex health and social care needs.

This study is designed to collect patient reported outcome data and movement data from the dominant wrist using an accelerometer among CCRS patients. Adult patients identified as being at high risk of complex rehabilitation needs are subjected for voluntary enrolment at hospital discharge. In addition to the routine CCRS follow ups, participants in our study complete a structured telephone assessment to evaluate their health related quality of life, physical capabilities, and cognitive function over the two months following discharge, complemented by continuous wrist worn accelerometry for the entire study period.

This study will provide early evidence on the feasibility and value of integrating continuous wearable monitoring with repeated patient-reported assessments during the early post-ICU period. By linking real-world activity patterns with key domains of recovery, the findings will help identify meaningful digital indicators of deterioration or unmet rehabilitation needs.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of wearable data collection
Time Frame: 2 months after hospital discharge

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telephone Questionnaire Completion Rate
Time Frame: 2 months after hospital discharge
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.
2 months after hospital discharge
Unplanned hospital readmission rate
Time Frame: 2 months after hospital discharge.
The proportion of participants experiencing at least one unplanned hospital readmission following the index discharge.
2 months after hospital discharge.
All-cause mortality
Time Frame: 2 months after hospital discharge.
The proportion of participants who die from any cause following index hospital discharge.
2 months after hospital discharge.
Health-Related Quality of Life (HRQoL)
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.
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).
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
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.
Assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI yields a global score ranging from 0 to 21, where lower scores denote superior sleep quality and a score > 5 indicates significant sleep disturbance.
Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.
Cognitive Function
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.
Assessed using the Telephone Montreal Cognitive Assessment (T-MoCA). Total scores range from 0 to 22, with higher scores indicating better cognitive performance.
Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.
Physical Function
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.
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form (PF-10a). The PF-10a is scored by summing raw scores from 10 items (rated 1-5), which are converted into a standardized T-score using conversion tables, where higher scores indicate better physical function.
Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2026

Primary Completion (Estimated)

July 3, 2026

Study Completion (Estimated)

August 28, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC25224
  • 15096009 (Other Grant/Funding Number: NHS Lothian Intensive Care Charity)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Intensive Care Syndrome (PICS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe