Web-based Follow-up to Former ICU Patients

Post Intensive Care Unit Syndrome Clinical Trial

— WIVA  

Official title:

Web-based Follow-up to Former ICU Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04317144
• Other study ID #: WIVA001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: October 7, 2025

Study information

• Verified date: May 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: October 7, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Post Intensive Care Unit Syndrome

Intervention

Behavioral:
• Web-based follow-up programme.
Participants who are randomized to the intervention-group will have access to web-based follow-up for one year. The programme includes short films of equipment used in intensive care e.g. ventilator, suction-device. Continous renal replacement therapy , central vein catheter among other things. About 15 short films with icu-staff talking and show how the equipment works and alarm sounds. The intervention also includes lectures about how the ICU works and what problems a critically ill patient can suffer from post-icu. There is a built-in conversation tool in the programme that can be used both by the participant and the staff who works with the follow-up programme. Questionnaires is sent out 2,6 and 12 month post-icu. The questions include PTSD, Depression, QoL and physical activity. At the end of the study, participants are sent a questionnaire asking for their experience using the web-based follow up programme.
• No follow-up
Participants randomized to "no follow-up" receive e-questionnaires 2, 6 and 12 months post-ICU care. The questions are the same as in web-based follow-up intervention group and include PTSD, Depression, QoL and physical activity.

Locations

Country	Name	City	State
Sweden	Uppsala University hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Web-based follow up post-ICU impact on participants mental status concerning PTSD compared with no follow-up.	Participant fill in questionnaire; Impact of event scale-revised (IES-R) which is screening for PTSD	Questionnaire will be sent out at 2, 6 and 12 month post-ICU.
Primary	Web-based follow up post-ICU impact on participants mental status regarding depression	Patient Health Questionnaire (PHQ-9) which is screening for depression	Questionnaire will be sent out at 2, 6 and 12 month post-ICU.
Primary	Web-based follow up post-ICU impact on participants ability to deal with health related problems	World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a questionnaire which measure difficulties dealing with health-related problems.	Questionnaire will be sent out at 2, 6 and 12 month post-ICU.
Primary	Web-based follow-up post-ICU impact on participants physical activity level compared with no follow-up?	Participant answer one questionnaire; level of physical activity pre- and post ICU.	Questionnaires are sent out at 2, 6 and 12 month post-ICU.
Primary	Participants will be asked what their opinions is on using web-based follow-up.	Semi-structured form	Questionnaire are sent at the end of the study-period.
Secondary	Participants will be asked if they have unexpected hospital visit with health issues related to their ICU-stay.	Question sent out: Have you had unexpected hospital visits with health issues related to their ICU-stay.	This question is sent out at 2, 6 and 12 month post-ICU.