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| ID | Type | Description | Link |
|---|---|---|---|
| 15096009 | Other Grant/Funding Number | NHS Lothian Intensive Care Charity |
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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:
Participants will:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of wearable data collection | The proportion of enrolled post-ICU patients achieving successful data collection. Successful data collection is defined as:
| 2 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months after hospital discharge |
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Inclusion Criteria:
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
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Adults discharged from an intensive care unit and hospital who are at high risk of post-ICU syndrome and hospital readmission.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoeb Jiwaji, Dr | Contact | 0044 (0)131 242 1186 | zoeb.jiwaji@ed.ac.uk | |
| Barat Ospanov, Dr | Contact | b.ospanov@sms.ed.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Infirmary of Edinburgh | Recruiting | Edinburgh | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Public Health Scotland, Scottish Intensive Care Society Audit Group, 2024. Audit of Critical Care in Scotland 2024: Reporting on 2023. Public Health Scotland, Edinburgh | ||
| 35321894 | 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. | |
| 36015910 |
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| ID | Term |
|---|---|
| C000657744 | postintensive care syndrome |
| D016638 | Critical Illness |
| D060825 | Cognitive Dysfunction |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
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| Unplanned hospital readmission rate | The proportion of participants experiencing at least one unplanned hospital readmission following the index discharge. | 2 months after hospital discharge. |
| All-cause mortality | The proportion of participants who die from any cause following index hospital discharge. | 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). | 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. | 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. | 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. | Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge. |
| Western General Hospital | Recruiting | Edinburgh | EH4 2XU | United Kingdom |
|
| St Johns Hospital | Recruiting | Livingston | EH54 6PP | United Kingdom |
|
| 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. |
| 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. |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |