Web-based Follow-up to Former ICU Patients

NCT04317144 | Suspended

• 1 other identifier: WIVA001
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Intensive Care Unit Syndrome

Keywords

intensive care units; survivors; web-based

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• 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.

Study Arms (2)

Web-based follow-up programme

ACTIVE COMPARATOR

Participant randomized to the Web-based follow-up programme receive access to web-portal called www.1177.se

Behavioral: Web-based follow-up programme.

No follow-up.

ACTIVE COMPARATOR

Participants does not receive the web-based follow-up programme. e-questionnaires are sent out.

Behavioral: No follow-up

Interventions

Web-based follow-up programme. BEHAVIORAL

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.

Web-based follow-up programme

No follow-up BEHAVIORAL

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.

No follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University hospital

Uppsala, 75185, Sweden

Location

Related Publications (28)

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Study Officials

• Per Hellman, Phd

  Uppsala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization is a in-hospital after consent done by the researcher/ICU-nurse. The participant receives group-specific information after randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal observational study.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: March 23, 2020
• Study Start: January 7, 2019
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)