Post Intensive Care SyndromeICURANCT06504979
The Post Intensive Care Syndrome Follow-up and Management Study: The ICU Recovery Answers Project
A study testing Telehealth follow-up of post-intensive care syndrome in people with Post Intensive Care Syndrome and ICU Survivors, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Post Intensive Care Syndrome, ICU Survivors, ICU Families
- What is being tested?
- Telehealth follow-up of post-intensive care syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old) critically ill patients admitted to the ICU with or without need of invasive mechanical ventilation (IMV).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut d'Investigació i Innovació Parc Taulí
Sabadell, Barcelona, 08208
About this study
Official title: Implementation of a Digital Tool for the Telematic Follow-up and Management of Emotional and Cognitive Sequelae Related to Post-intensive Care Syndrome: Impact on Quality of Life and Functionality
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.
Read more
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.
- Conditions
- Post Intensive Care Syndrome, ICU Survivors, ICU Families
- Being tested
- Telehealth follow-up of post-intensive care syndrome
- Keywords
- Post-intensive Care Syndrome, ICU survivors, ICU families, Cognition, Emotional state
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth follow-up of post-intensive care syndromeOther
Using a telehealth platform for the detection of the emotional, neuropsychological and physical PICS-related sequelae along 12 months in ICU survivors
| Study group | Role | What they receive |
|---|---|---|
| ICURA follow-up | Experimental | Not described Receives: Other: Telehealth follow-up of post-intensive care syndrome |
| Standard Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
12-Item Short Form Survey (SF-12) Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 1, 6, 12 months after ICU discharge
Functionality
WHO Short Disability Assessement Schedule (WHODAS 2.0) Scores range from 0 to 60, with higher scores indicating higher level of disability.
Measured: 1, 6, 12 months after ICU discharge
Secondary outcomes (4)
Anxiety symptoms
Generalized Anxiety Disorder-7 (GAD-7) Scores range from 0 to 21, with higher scores indicating higher level of symptoms.
Measured: 1,6,12 months after ICU discharge
Depressive symptoms
Patient Health Questionnaire-9 (PHQ-9) Scores range from 0 to 27, with higher scores indicating higher level of symptoms.
Measured: 1, 6, 12 months after ICU discharge
Post-Traumatic Stress symptoms
Treatment-Outcome Post-Traumatic Stress Disorder Scale (TOP-8) Scores range from 0 to 32, with higher scores indicating higher level of symptoms.
Measured: 1, 6, 12 months after ICU discharge
Cognitive status
Montreal Cognitive Assessment (MoCA) Scores range from 0 to 30, with lower scores indicating higher level of cognitive impairment.
Measured: 1, 6, 12 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start2 Oct 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de les Illes Balears, Hospital Son Espases, Fundació La Marató de TV3
- Responsible party
- Principal investigator, Sol Fernandez-Gonzalo, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504979
- Sponsor's protocol ID
- 2022/3031
- Acronym
- ICURA
- Status last verified
- May 2026
- First submitted
- 18 Jun 2024
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Llabres-Alvarez E, Riera-Sagrera M, Llompart-Casasnovas A, Salva P, Castro A, Godoy-Gonzalez M, Dona-Lopez E, Lopez-Aguilar J, Jodar M, Navarra-Ventura G, Gili M, Roca M, Fernandez-Gonzalo S. Implementation of a digital tool for monitoring and managing the emotional and cognitive sequelae of post-intensive care syndrome: ICURA study protocol for a randomised clinical trial. BMJ Open. 2026 Apr 17;16(4):e112976. doi: 10.1136/bmjopen-2025-112976.
PubMed 41997709
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Digital Tool for the Telematic Follow-up and Management of Emotional and Cognitive Sequelae Related to Post-intensive Care Syndrome: Impact on Quality of Life and Functionality
- ClinicalTrials.gov ID
- NCT06504979
- Acronym / sponsor ID
- ICURA / 2022/3031
- Conditions
- Post Intensive Care Syndrome, ICU Survivors, ICU Families
- Keywords
- Post-intensive Care Syndrome, ICU survivors, ICU families, Cognition, Emotional state
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Universitat de les Illes Balears, Hospital Son Espases, Fundació La Marató de TV3
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICURA follow-up | Experimental | Other: Telehealth follow-up of post-intensive care syndrome |
| Standard Group | No intervention | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (≥18 years old) critically ill patients admitted to the ICU with or without need of invasive mechanical ventilation (IMV).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth follow-up of post-intensive care syndromeUsing a telehealth platform for the detection of the emotional, neuropsychological and physical PICS-related sequelae along 12 months in ICU survivors | Other | ICURA follow-up |
Primary outcome
Health-related quality of life
Time frame: 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
Time frame: 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.
4 secondary outcomes
Anxiety symptoms
Time frame: 1,6,12 months after ICU discharge
Depressive symptoms
Time frame: 1, 6, 12 months after ICU discharge
Post-Traumatic Stress symptoms
Time frame: 1, 6, 12 months after ICU discharge
Cognitive status
Time frame: 1, 6, 12 months after ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 41997709Llabres-Alvarez E, Riera-Sagrera M, Llompart-Casasnovas A, Salva P, Castro A, Godoy-Gonzalez M, Dona-Lopez E, Lopez-Aguilar J, Jodar M, Navarra-Ventura G, Gili M, Roca M, Fernandez-Gonzalo S. Implementation of a digital tool for monitoring and managing the emotional and cognitive sequelae of post-intensive care syndrome: ICURA study protocol for a randomised clinical trial. BMJ Open. 2026 Apr 17;16(4):e112976. doi: 10.1136/bmjopen-2025-112976.
- ICURA project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth follow-up of post-intensive care syndrome in people with Post Intensive Care Syndrome and ICU Survivors, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 1, 6, 12 months after ICU discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06504979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.