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Post Intensive Care Unit SyndromeWIVANCT04317144

Web-based Follow-up to Former ICU Patients

A study testing Web-based follow-up programme. and No follow-up in people with Post Intensive Care Unit Syndrome, run by Uppsala University at 1 site in Sweden.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Intensive Care Unit Syndrome
What is being tested?
Web-based follow-up programme. and No follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteSweden
Study dates
7 Jan 2019to Oct 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.)

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Uppsala University hospital

    Uppsala, 75185

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Web-based follow-up programme., No follow-up
Keywords
intensive care units, survivors, web-based

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based follow-up programme.Behavioural

    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-upBehavioural

    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.

Study groups in NCT04317144
Study groupRoleWhat they receive
Web-based follow-up programmeActive comparatorParticipant randomized to the Web-based follow-up programme receive access to web-portal called www.1177.se
Receives: Behavioral: Web-based follow-up programme.
No follow-up.Active comparatorParticipants does not receive the web-based follow-up programme. e-questionnaires are sent out.
Receives: Behavioral: No follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Questionnaire will be sent out at 2, 6 and 12 month post-ICU.

  2. Web-based follow up post-ICU impact on participants mental status regarding depression

    Patient Health Questionnaire (PHQ-9) which is screening for depression

    Measured: Questionnaire will be sent out at 2, 6 and 12 month post-ICU.

  3. 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.

    Measured: Questionnaire will be sent out at 2, 6 and 12 month post-ICU.

  4. 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.

    Measured: Questionnaires are sent out at 2, 6 and 12 month post-ICU.

  5. Participants will be asked what their opinions is on using web-based follow-up.

    Semi-structured form

    Measured: Questionnaire are sent at the end of the study-period.

Secondary outcomes (1)
  1. 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.

    Measured: This question is sent out at 2, 6 and 12 month post-ICU.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start7 Jan 2019
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Why it stopped: The researcher is no longer a PhD student

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Longitudinal observational study.
Masking
Single blind
Who is masked
Investigator
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317144
Sponsor's protocol ID
WIVA001
Acronym
WIVA
Status last verified
Apr 2026
First submitted
16 Jan 2020
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Olsson SJ, Ekblom O, Andersson E, Borjesson M, Kallings LV. Categorical answer modes provide superior validity to open answers when asking for level of physical activity: A cross-sectional study. Scand J Public Health. 2016 Feb;44(1):70-6. doi: 10.1177/1403494815602830. Epub 2015 Sep 21.

    PubMed 26392418
  • Vad är Intensivvård - SIR-Svenska Intensivvardsregistret [Internet]. [citerad 23 april 2018]. available at: http://www.icuregswe.org/sv/For-patienter/Vad-ar-Intensivvard/

  • Pfoh ER, Wozniak AW, Colantuoni E, Dinglas VD, Mendez-Tellez PA, Shanholtz C, Ciesla ND, Pronovost PJ, Needham DM. Physical declines occurring after hospital discharge in ARDS survivors: a 5-year longitudinal study. Intensive Care Med. 2016 Oct;42(10):1557-1566. doi: 10.1007/s00134-016-4530-1. Epub 2016 Sep 16.

    PubMed 27637716
  • Hofhuis JG, Spronk PE, van Stel HF, Schrijvers AJ, Rommes JH, Bakker J. Experiences of critically ill patients in the ICU. Intensive Crit Care Nurs. 2008 Oct;24(5):300-13. doi: 10.1016/j.iccn.2008.03.004. Epub 2008 May 9.

    PubMed 18472265
  • Samuelson K, Lundberg D, Fridlund B. Memory in relation to depth of sedation in adult mechanically ventilated intensive care patients. Intensive Care Med. 2006 May;32(5):660-7. doi: 10.1007/s00134-006-0105-x. Epub 2006 Mar 7.

    PubMed 16520999
  • Svenningsen H, Egerod I, Dreyer P. Strange and scary memories of the intensive care unit: a qualitative, longitudinal study inspired by Ricoeur's interpretation theory. J Clin Nurs. 2016 Oct;25(19-20):2807-15. doi: 10.1111/jocn.13318. Epub 2016 Jul 26.

    PubMed 27457029
  • Myhren H, Ekeberg O, Toien K, Karlsson S, Stokland O. Posttraumatic stress, anxiety and depression symptoms in patients during the first year post intensive care unit discharge. Crit Care. 2010;14(1):R14. doi: 10.1186/cc8870. Epub 2010 Feb 8.

    PubMed 20144193
  • Peris A, Bonizzoli M, Iozzelli D, Migliaccio ML, Zagli G, Bacchereti A, Debolini M, Vannini E, Solaro M, Balzi I, Bendoni E, Bacchi I, Trevisan M, Giovannini V, Belloni L. Early intra-intensive care unit psychological intervention promotes recovery from post traumatic stress disorders, anxiety and depression symptoms in critically ill patients. Crit Care. 2011;15(1):R41. doi: 10.1186/cc10003. Epub 2011 Jan 27.

    PubMed 21272307
  • Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

    PubMed 21946660
  • de Azevedo JR, Montenegro WS, Rodrigues DP, de C Souza SC, Araujo VF, de Paula MP, Prazeres PH, da Luz Leitao A, Mendonca AV. Long-term cognitive outcomes among unselected ventilated and non-ventilated ICU patients. J Intensive Care. 2017 Feb 17;5:18. doi: 10.1186/s40560-017-0213-4. eCollection 2017.

    PubMed 28239475
  • Choi J, Hoffman LA, Schulz R, Tate JA, Donahoe MP, Ren D, Given BA, Sherwood PR. Self-reported physical symptoms in intensive care unit (ICU) survivors: pilot exploration over four months post-ICU discharge. J Pain Symptom Manage. 2014 Feb;47(2):257-70. doi: 10.1016/j.jpainsymman.2013.03.019. Epub 2013 Jul 12.

    PubMed 23856099
  • 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

  • Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.

    PubMed 18511703
  • Sharshar T, Bastuji-Garin S, Stevens RD, Durand MC, Malissin I, Rodriguez P, Cerf C, Outin H, De Jonghe B; Groupe de Reflexion et d'Etude des Neuromyopathies En Reanimation. Presence and severity of intensive care unit-acquired paresis at time of awakening are associated with increased intensive care unit and hospital mortality. Crit Care Med. 2009 Dec;37(12):3047-53. doi: 10.1097/CCM.0b013e3181b027e9.

    PubMed 19770751
  • Wolters AE, Slooter AJ, van der Kooi AW, van Dijk D. Cognitive impairment after intensive care unit admission: a systematic review. Intensive Care Med. 2013 Mar;39(3):376-86. doi: 10.1007/s00134-012-2784-9. Epub 2013 Jan 18.

    PubMed 23328935

Questions about this trial

What is this clinical trial studying?

A study testing Web-based follow-up programme. and No follow-up in people with Post Intensive Care Unit Syndrome, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317144, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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