Post Intensive Care Accelerometery to Study and Support Recovery Outcomes

Обзор

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

Подробное описание

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.

Первичные конечные точки

• Feasibility of wearable data collection [Срок оценки: 2 months after hospital discharge]

Вторичные конечные точки (7)

• Telephone Questionnaire Completion Rate [Срок оценки: 2 months after hospital discharge]
• Unplanned hospital readmission rate [Срок оценки: 2 months after hospital discharge.]
• All-cause mortality [Срок оценки: 2 months after hospital discharge.]
• Health-Related Quality of Life (HRQoL) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (Day 0 ± 5), 2 weeks (Day 14 ± 3), 1 month (Day 28 ± 3), and 2 months (Day 56 ± 3) post-hospital discharge.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 3 центра

• The Royal Infirmary of Edinburgh — Edinburgh
• Western General Hospital — Edinburgh
• St Johns Hospital — Livingston

Публикации

• 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. PMID 35321894
• 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
• 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.

Идентификаторы

NCT: NCT07466446 · AC25224 · 15096009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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