Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)
NCT07599306
Atrophy, Cardiopathy
Milan, Milano, Italy
View Trial DetailsNCT Number: NCT07466446
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 months after hospital discharge
The proportion of enrolled post-ICU patients achieving successful data collection.
Successful data collection is defined as:
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.
Time frame: 2 months after hospital discharge.
The proportion of participants experiencing at least one unplanned hospital readmission following the index discharge.
Time frame: 2 months after hospital discharge.
The proportion of participants who die from any cause following index hospital discharge.
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Barat Ospanov, Dr
CONTACT
Zoeb Jiwaji, Dr
CONTACT
University of Edinburgh
Other
Acronym: PICASSO
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