Post Intensive Care Syndrome (PICS)PICASSONCT07466446
Post Intensive Care Accelerometery to Study and Support Recovery Outcomes
An observational study of Post Intensive Care Syndrome (PICS), run by University of Edinburgh at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome (PICS)
- How many people
- 40 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 30 Mar 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults discharged from an intensive care unit and hospital who are at high risk of post-ICU syndrome and hospital readmission.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Barat Ospanov, Dr contact
United Kingdom3 sites, 3 recruiting
- Recruiting
The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Zoeb Jiwaji, Dr, zoeb.jiwaji@ed.ac.uk
Barat Ospanov, Dr, b.ospanov@sms.ed.ac.uk
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
Zoeb Jiwaji, Dr, zoeb.jiwaji@ed.ac.uk
- Recruiting
St Johns Hospital
Livingston, EH54 6PP
Zoeb Jiwaji, Dr, zoeb.jiwaji@ed.ac.uk
About this study
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:
Read more
- 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
Read the 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.
- 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
- Medical subject headings
- postintensive care syndrome, Critical Illness, Cognitive Dysfunction, Pain, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months after hospital discharge
Secondary outcomes (7)
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.
Measured: 2 months after hospital discharge
Unplanned hospital readmission rate
The proportion of participants experiencing at least one unplanned hospital readmission following the index discharge.
Measured: 2 months after hospital discharge.
All-cause mortality
The proportion of participants who die from any cause following index hospital discharge.
Measured: 2 months after hospital discharge.
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).
Measured: 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
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.
Measured: 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
Assessed using the Telephone Montreal Cognitive Assessment (T-MoCA). Total scores range from 0 to 22, with higher scores indicating better cognitive performance.
Measured: 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
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.
Measured: Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start30 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care Syndrome (PICS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466446
- Sponsor's protocol ID
- AC25224
- Other IDs
- 15096009
- Acronym
- PICASSO
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Public Health Scotland, Scottish Intensive Care Society Audit Group, 2024. Audit of Critical Care in Scotland 2024: Reporting on 2023. Public Health Scotland, Edinburgh
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.
PubMed 35321894Tsanas 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.
PubMed 36015910National 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Intensive Care Accelerometery to Study and Support Recovery Outcomes
- ClinicalTrials.gov ID
- NCT07466446
- Acronym / sponsor ID
- PICASSO / AC25224
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults discharged from an intensive care unit and hospital who are at high risk of post-ICU syndrome and hospital readmission.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Telephone Questionnaire Completion Rate
Time frame: 2 months after hospital discharge
Unplanned hospital readmission rate
Time frame: 2 months after hospital discharge.
All-cause mortality
Time frame: 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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- BackgroundPublic Health Scotland, Scottish Intensive Care Society Audit Group, 2024. Audit of Critical Care in Scotland 2024: Reporting on 2023. Public Health Scotland, Edinburgh
- Background: PubMed 35321894Walsh 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.
- Background: PubMed 36015910Tsanas 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.
- BackgroundNational 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barat Ospanov, Dr contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Syndrome (PICS), run by University of Edinburgh at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoeb Jiwaji, Dr (0044 (0)131 242 1186, zoeb.jiwaji@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of wearable data collection (time frame: 2 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466446, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.