Post Intensive Care Syndrome (PICS)
Conditions
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
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
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.
Interventions
None listed
Sponsors
University of Edinburgh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of wearable data collection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Telephone Questionnaire Completion Rate | 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. |
| Unplanned hospital readmission rate | 2 months after hospital discharge. | The proportion of participants experiencing at least one unplanned hospital readmission following the index discharge. |
| All-cause mortality | 2 months after hospital discharge. | The proportion of participants who die from any cause following index 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. | 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). |
| 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. | 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. |
| Cognitive Function | 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. |
| 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. | 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. |
Countries
United Kingdom
Contacts
CONTACTZoeb Jiwaji, Dr
CONTACTBarat Ospanov, Dr
Outcome results
None listed