Clinical trial NCT04317144: Web-based Follow-up to Former ICU Patients
Official title: Web-based Follow-up to Former ICU Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post Intensive Care Unit Syndrome
Keywords: intensive care units
survivors
web-based
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal observational study.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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).

Primary outcomes:
measure: Web-based follow up post-ICU impact on participants mental status concerning PTSD compared with no follow-up.
timeFrame: Questionnaire will be sent out at 2, 6 and 12 month post-ICU.
measure: Web-based follow up post-ICU impact on participants mental status regarding depression
timeFrame: Questionnaire will be sent out at 2, 6 and 12 month post-ICU.
measure: Web-based follow up post-ICU impact on participants ability to deal with health related problems
timeFrame: Questionnaire will be sent out at 2, 6 and 12 month post-ICU.
measure: Web-based follow-up post-ICU impact on participants physical activity level compared with no follow-up?
timeFrame: Questionnaires are sent out at 2, 6 and 12 month post-ICU.
measure: Participants will be asked what their opinions is on using web-based follow-up.
timeFrame: Questionnaire are sent at the end of the study-period.
Secondary outcomes:
measure: Participants will be asked if they have unexpected hospital visit with health issues related to their ICU-stay.
timeFrame: This question is sent out at 2, 6 and 12 month post-ICU.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University hospital
Study officials:
affiliation: Uppsala University
name: Per Hellman, Phd
role: STUDY_CHAIR
References:
citation: 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.
citation: Vad är Intensivvård - SIR-Svenska Intensivvardsregistret [Internet]. [citerad 23 april 2018]. available at: http://www.icuregswe.org/sv/For-patienter/Vad-ar-Intensivvard/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: Schandl A, Bottai M, Holdar U, Hellgren E, Sackey P. Early prediction of new-onset physical disability after intensive care unit stay: a preliminary instrument. Crit Care. 2014 Jul 31;18(4):455. doi: 10.1186/s13054-014-0455-7.
citation: Åkerman E, Fridh I, Orwelius L, Ringdal M, Shandl A. Nationella rekommendationer för uppföljning av patienter efter intensivvård. Riksföreningen Anestesi och intensivvård; 130617.
citation: Jensen JF, Thomsen T, Overgaard D, Bestle MH, Christensen D, Egerod I. Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Intensive Care Med. 2015 May;41(5):763-75. doi: 10.1007/s00134-015-3689-1. Epub 2015 Mar 3.
citation: Glimelius Petersson C, Bergbom I, Brodersen K, Ringdal M. Patients' participation in and evaluation of a follow-up program following intensive care. Acta Anaesthesiol Scand. 2011 Aug;55(7):827-34. doi: 10.1111/j.1399-6576.2011.02474.x. Epub 2011 Jun 9.
citation: Agard AS, Egerod I, Tonnesen E, Lomborg K. Struggling for independence: a grounded theory study on convalescence of ICU survivors 12 months post ICU discharge. Intensive Crit Care Nurs. 2012 Apr;28(2):105-13. doi: 10.1016/j.iccn.2012.01.008. Epub 2012 Feb 25.
citation: Castillo MI, Cooke ML, Macfarlane B, Aitken LM. In ICU state anxiety is not associated with posttraumatic stress symptoms over six months after ICU discharge: A prospective study. Aust Crit Care. 2016 Aug;29(3):158-64. doi: 10.1016/j.aucc.2015.09.003. Epub 2015 Nov 6.
citation: Hogberg KM, Sandman L, Nystrom M, Stockelberg D, Brostrom A. Caring Through Web-Based Communication: A Qualitative Evaluation of a Nursing Intervention to Create Holistic Well-Being Among Patients With Hematological Disease. J Holist Nurs. 2018 Sep;36(3):218-227. doi: 10.1177/0898010116667343. Epub 2016 Sep 22.
citation: Wu RC, Delgado D, Costigan J, Maciver J, Ross H. Pilot study of an Internet patient-physician communication tool for heart failure disease management. J Med Internet Res. 2005 Mar 26;7(1):e8. doi: 10.2196/jmir.7.1.e8.
citation: Stjernsward S, Hansson L. User value and usability of a web-based mindfulness intervention for families living with mental health problems. Health Soc Care Community. 2017 Mar;25(2):700-709. doi: 10.1111/hsc.12360. Epub 2016 May 17.
citation: Sveen J, Low A, Dyster-Aas J, Ekselius L, Willebrand M, Gerdin B. Validation of a Swedish version of the Impact of Event Scale-Revised (IES-R) in patients with burns. J Anxiety Disord. 2010 Aug;24(6):618-22. doi: 10.1016/j.janxdis.2010.03.021. Epub 2010 Apr 12.
citation: Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59. doi: 10.1016/j.genhosppsych.2010.03.006. Epub 2010 May 7.
citation: Carlozzi NE, Kratz AL, Downing NR, Goodnight S, Miner JA, Migliore N, Paulsen JS. Validity of the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) in individuals with Huntington disease (HD). Qual Life Res. 2015 Aug;24(8):1963-71. doi: 10.1007/s11136-015-0930-x. Epub 2015 Jan 31.
citation: Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.