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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06438380
Other study ID # 2023/5126
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date December 2024

Study information

Verified date May 2024
Source Parc Tauli Research and Innovation Institute Foundation
Contact Marta Godoy-González, PhD student
Phone +34937236673
Email mrgodoy@tauli.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Survivors of critical illness may present with a set of physical, emotional and cognitive sequelae, known as Post Intensive Care Syndrome (PICS). These alterations can become chronic over time and significantly affect patients' quality of life. Therefore, follow-up and monitoring of critically ill patients after ICU discharge, for example through telemedicine, could be essential for the prevention, early detection and management of PICS. Our main objective is to evaluate the suitability and user experience of a telemedicine platform from the perspective of critically ill patients. This study proposes the participation of ICU survivors in the design and improvement of a telemedicine platform for PICS follow-up through a qualitative approach. Participants will test the platform in person three months after discharge from the ICU and then undergo a semi-structured interview to assess their experience. The findings derived from this study may contribute to improve both the content and the format of the platform, optimizing resources and facilitating the management of post-ICU sequelae, which will have a positive impact on the patient's recovery process.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 14
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (=18 years) - Admitted to a medical/surgical ICU - For respiratory failure, cardiogenic shock, or septic shock - With an expected ICU stay of =48 hours - Catalan and/or Spanish speakers - Who are able to give informed consent by themselves Exclusion Criteria: - History of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder - History of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, Alzheimer's disease, Parkinson's disease or multiple sclerosis - History of brain damage, such as traumatic brain injury or stroke - History of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder - Suspected or confirmed substance use disorder - Suspected or confirmed communicable disease in an isolated patient - Uncorrected hearing or visual impairment - Enrolled in another trial that does not allow co-enrollment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Parc Tauli Research and Innovation Institute Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 1:1 semi-structured interviews To evaluate the user experience of a telemedicine platform for monitoring post-intensive care syndrome from the perspective of critically ill patients after ICU discharge through semi-structured interviews 3 months after ICU discharge
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