NCT06438380

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 27, 2024

Last Update Submit

May 27, 2024

Conditions

Keywords

Qualitative researchPost-Intensive Care Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients admitted to the ICU of the Parc Tauli Hospital (Sabadell, Spain).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical Illnesspostintensive care syndrome

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Marta Godoy-González, PhD student

CONTACT

Sol Fernández-Gonzalo, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

May 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05