Web-based Follow-up to Former ICU Patients (WIVA)

November 8, 2022 updated by: Uppsala University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Web-based follow-up programme
Participant randomized to the Web-based follow-up programme receive access to web-portal called www.1177.se
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.
Active Comparator: No follow-up.
Participants does not receive the web-based follow-up programme. e-questionnaires are sent out.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Web-based follow up post-ICU impact on participants mental status concerning PTSD compared with no follow-up.
Time Frame: 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
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
Time Frame: Questionnaire will be sent out at 2, 6 and 12 month post-ICU.
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
Time Frame: 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.
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?
Time Frame: Questionnaires are sent out at 2, 6 and 12 month post-ICU.
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.
Time Frame: Questionnaire are sent at the end of the study-period.
Semi-structured form
Questionnaire are sent at the end of the study-period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants will be asked if they have unexpected hospital visit with health issues related to their ICU-stay.
Time Frame: 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.
This question is sent out at 2, 6 and 12 month post-ICU.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Study Chair: Per Hellman, Phd, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 7, 2023

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WIVA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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