ICU Families, ICU Survivors, Post Intensive Care Syndrome
Conditions
Keywords
Post-intensive Care Syndrome, ICU survivors, ICU families, Cognition, Emotional state
Brief summary
Critically ill survivors develop mental health, cognition, and mobility sequelae known as Post-Intensive Care Syndrome (PICS). Clinically significant symptoms of post-traumatic stress, depression, anxiety, and cognitive impairment are frequently observed at short- and long-term after ICU, impacting quality of life of the survivors and their relatives. The main objective of the project is to optimize, implement and evaluate the impact in quality of life of a digital platform (ICURA) specifically designed for following-up and managing the mental health sequelae related to PICS in ICU survivors and their relatives during the one-year recovery phase. Methods: Observational, prospective and multicenter study including two cohorts: 1) ICU patients' cohort (ICUcohort), and 2) ICU patients' family cohort (ICU-F-cohort). After ICU discharge, patients will be randomized to participate in a follow-up with ICURA vs. the standard follow-up. Expected results: Critically ill survivors in the APPICS program after ICU will show better levels of functionality and quality of life than those participants in the usual follow-up. APPICS will contribute to enhancing the prognosis of emotional alterations during the 12 months after ICU both, in ICU survivors, and relatives. Analyzing risk factors, based on demographic and clinical data, will help to the early detection of long-term mental health difficulties in ICU survivors.
Interventions
OTHERTelehealth follow-up of post-intensive care syndrome
Using a telehealth platform for the detection of the emotional, neuropsychological and physical PICS-related sequelae along 12 months in ICU survivors
Sponsors
Corporacion Parc Tauli
Universitat de les Illes Balears
Hospital Son Espases
Fundació La Marató de TV3
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Adult (≥18 years old) critically ill patients admitted to the ICU with or without need of invasive mechanical ventilation (IMV).
Exclusion criteria
* Non-authorization of the relatives and/or patient to inclusion in the study; neurocritical ICU patients. * Severe neurological pathology (including dementia or focal brain damage with functional and cognitive impairment) prior to admission to the ICU. * Severe psychiatric pathology (schizophrenia, bipolar disorder, major depressive disorder) * Intellectual disability (IQ \<80). * Patients who develop secondary complications (infections, stroke, TBI or any non-transient acquired brain damage) after ICU discharge, that may compromise the results of the emotional and neuropsychological evaluation during the recovery phase * Moderate-severe cognitive impairment (Short-IQCODE \>85) that impair ICU patients an independent participation in the telematic follow up and accompaniment program * Readmission to ICU within 12 months after discharge from ICU * Idiomatic barrier (non spanish and/or catalan speaker) * Patients with life expectancy \<1 year or not subsidiaries of active treatment measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 1, 6, 12 months after ICU discharge | 12-Item Short Form Survey (SF-12) Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. |
| Functionality | 1, 6, 12 months after ICU discharge | WHO Short Disability Assessement Schedule (WHODAS 2.0) Scores range from 0 to 60, with higher scores indicating higher level of disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety symptoms | 1,6,12 months after ICU discharge | Generalized Anxiety Disorder-7 (GAD-7) Scores range from 0 to 21, with higher scores indicating higher level of symptoms. |
| Depressive symptoms | 1, 6, 12 months after ICU discharge | Patient Health Questionnaire-9 (PHQ-9) Scores range from 0 to 27, with higher scores indicating higher level of symptoms. |
| Post-Traumatic Stress symptoms | 1, 6, 12 months after ICU discharge | Treatment-Outcome Post-Traumatic Stress Disorder Scale (TOP-8) Scores range from 0 to 32, with higher scores indicating higher level of symptoms. |
| Cognitive status | 1, 6, 12 months after ICU discharge | Montreal Cognitive Assessment (MoCA) Scores range from 0 to 30, with lower scores indicating higher level of cognitive impairment. |
Countries
Spain
Outcome results
None listed