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
|Condition or disease||Intervention/treatment||Phase|
|Post Intensive Care Unit Syndrome||Behavioral: Web-based follow-up programme. Behavioral: No follow-up||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Longitudinal observational study.|
|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|
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.
- 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
- 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
- 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.
- 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.
- 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
- 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.
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
|Contact: Sten Rubertsson, Phdfirstname.lastname@example.org|
|Uppsala University hospital||Recruiting|
|Uppsala, Sweden, 75185|
|Contact: Sten Rubertsson, Phd +46708693996 email@example.com|
|Study Chair:||Per Hellman, Phd||UPPSALA UNIVERSITET|