Web-based Follow-up to Former ICU Patients

Not Applicable

Active, not recruiting

• Conditions: Post Intensive Care Unit Syndrome
• Interventions: Behavioral: Web-based follow-up programme.; Behavioral: No follow-up

• Registration Number: NCT04317144
• Lead Sponsor: Uppsala University

Brief Summary

This study evaluates if a web-based 1-year programme is a useful method for follow-up intensive care survivors with short ICU-stay. Half of the participants are randomized into receiving the web-based follow-up while the other half will receive no follow-up.

Detailed Description

It is not uncommon for Intensive care survivors to have persisting, psychiatric, cognitive and physical impairments long time after the critical illness occurred. Today, nurse-led follow-up is used but the main focus is on patients with a ICU-stay for at least three days. This study evaluates ICU-survivors with a maximum ICU-stay for 72 hours.

Participants are randomized to the web-based one year follow-up programme and no follow-up. Both group receive questionnaire 2, 6 and 12 month after the end of their intensive care stay.

The web-based follow-up programme includes, short lectures that describes the intensive care e.g. hallucinations, memory loss and delirium. The programme also include short films that shows the medical equipment and how and why it´s used. Regular contact with ICU-nurse to discuss any upcoming problems.

Study Timeline

• Study Start: 2019-01-07
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• ≥18 years of age.
• Treated at the ICU under the time of the study.
• Have a Bank-id (which is needed to log in to the website.)

Exclusion Criteria

• Institutionalized due to severe cognitive deficit.
• Does not communicate in the Swedish language.
• Patient is moved from other ICU to ICU where study is being held.
• Patient is sent to another ICU from ICU where study is being held.
• No home address.
• Patient decline to participate in study.
• Patient is receiving psychiatric specialist care post-icu e.g. high suicide risk.
• Patient is receiving ICU-treatment due to violence and is under on-going police-investigation.
• Palliative care.
• Patient receiving in-hospital care for more than 4 weeks in a row (except patient who is cared for in physical rehab-clinic at the hospital).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based follow-up programme	Web-based follow-up programme.	Participant randomized to the Web-based follow-up programme receive access to web-portal called www.1177.se
No follow-up.	No follow-up	Participants does not receive the web-based follow-up programme. e-questionnaires are sent out.

Primary Outcome Measures

Name	Time	Method
Web-based follow up post-ICU impact on participants mental status concerning PTSD compared with no follow-up.	Questionnaire will be sent out at 2, 6 and 12 month post-ICU.	Participant fill in questionnaire; Impact of event scale-revised (IES-R) which is screening for PTSD
Web-based follow up post-ICU impact on participants mental status regarding depression	Questionnaire will be sent out at 2, 6 and 12 month post-ICU.	Patient Health Questionnaire (PHQ-9) which is screening for depression
Web-based follow up post-ICU impact on participants ability to deal with health related problems	Questionnaire will be sent out at 2, 6 and 12 month post-ICU.	World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a questionnaire which measure difficulties dealing with health-related problems.
Web-based follow-up post-ICU impact on participants physical activity level compared with no follow-up?	Questionnaires are sent out at 2, 6 and 12 month post-ICU.	Participant answer one questionnaire; level of physical activity pre- and post ICU.
Participants will be asked what their opinions is on using web-based follow-up.	Questionnaire are sent at the end of the study-period.	Semi-structured form

Secondary Outcome Measures

Name	Time	Method
Participants will be asked if they have unexpected hospital visit with health issues related to their ICU-stay.	This question is sent out at 2, 6 and 12 month post-ICU.	Question sent out: Have you had unexpected hospital visits with health issues related to their ICU-stay.

Trial Locations

Locations (1)

Uppsala University hospital; 🇸🇪 Uppsala, Sweden