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

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ClinicalTrials.gov Identifier: NCT04317144
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Post Intensive Care Unit Syndrome Behavioral: Web-based follow-up programme. Behavioral: No follow-up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Longitudinal observational study.
Masking: Single (Investigator)
Masking Description: Randomization is a in-hospital after consent done by the researcher/ICU-nurse. The participant receives group-specific information after randomization.
Primary Purpose: Supportive Care
Official Title: Web-based Follow-up to Former ICU Patients
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : January 7, 2023

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.




Primary Outcome Measures :
  1. Web-based follow up post-ICU impact on participants mental status concering 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

  2. 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

  3. 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.

  4. 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.

  5. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317144


Contacts
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Contact: Sten Rubertsson, Phd +46186110000 sten.rubertsson@surgsci.uu.se

Locations
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Sweden
Uppsala University hospital Recruiting
Uppsala, Sweden, 75185
Contact: Sten Rubertsson, Phd    +46708693996    sten.rubertsson@akademiska.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Study Chair: Per Hellman, Phd UPPSALA UNIVERSITET

Publications:
Vad är Intensivvård - SIR-Svenska Intensivvardsregistret [Internet]. [citerad 23 april 2018]. available at: http://www.icuregswe.org/sv/For-patienter/Vad-ar-Intensivvard/
Ramnarain, D., Rutten, A., Van der Nat, G. et al. The impact of post intensive care syndrome in patients surviving the ICU: the downside of ICU treatment. ICMx 3, A530 (2015) doi:10.1186/2197-425X-3-S1-A530
Åkerman E, Fridh I, Orwelius L, Ringdal M, Shandl A. Nationella rekommendationer för uppföljning av patienter efter intensivvård. Riksföreningen Anestesi och intensivvård; 130617.

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT04317144    
Other Study ID Numbers: WIVA001
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
intensive care units
survivors
web-based