Evaluation of an ICU-specific Questionnaire for Patient-reported Outcome Measures

NCT02767180 | Completed

• 1 other identifier: LUA-74200
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

An ICU-specific questionnaire for patient reported outcome measures (PROM) after critical care will be tested in a study of 650 patients recruited six months to three years after discharge from the ICU, and 150 controls who have not been critically ill, matched for age and sex. The questionnaire is sent by mail after an invitation letter followed by a phone call and returned in a pre-stamped envelope. It is then scanned and data imported digitally. Medical data from the ICU-stay can be added. Further analyses after comparison with the control population and item reduction will follow.

Conditions

Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (1)

• Patient reported outcome measured with an ICU-specific questionnaire

  An ICU-specific questionnaire will be used which has been developed from interviews of former ICU-patients

  Six months to 3 years after intensive care

Study Arms (2)

Critical care survivors

Former ICU-patients recruited six months to three years after discharge from the ICU

Matched controls

Control patients who have not been critically ill, matched for age and sex.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients recruited six months to three years after discharge from the ICU, and 150 controls who have not been critically ill, matched for age and sex.

You may qualify if:

• Patients treated in an intensive care unit at Sahlgrenska University for more than 72 hours and survived are included between 6 months and tre years after discharge from ICU.
• Control persons from the Swedish Population Registry matched for sex and gender are also included.

You may not qualify if:

• Patient with acute neurological/neurosurgical conditions and/or anoxic/hypoxic brain damage

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

Location

Related Publications (4)

• Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

  PMID: 24088092 RESULT

• Johannesson E, Malmgren J. Self-confidence as a mediator in the relationship between executive functioning and depression among ICU survivors: a latent variable analysis. Crit Care. 2024 Oct 26;28(1):345. doi: 10.1186/s13054-024-05136-2.

  PMID: 39462425 DERIVED

• Malmgren J, Lundin S, Waldenstrom AC, Rylander C, Johannesson E. Quality of life-related and non-quality of life-related issues in ICU survivors and non-ICU-treated controls: a multi-group exploratory factor analysis. Crit Care. 2024 Mar 29;28(1):102. doi: 10.1186/s13054-024-04890-7.

  PMID: 38553749 DERIVED

• Malmgren J, Waldenstrom AC, Rylander C, Johannesson E, Lundin S. Long-term health-related quality of life and burden of disease after intensive care: development of a patient-reported outcome measure. Crit Care. 2021 Feb 25;25(1):82. doi: 10.1186/s13054-021-03496-7.

  PMID: 33632271 DERIVED

Study Officials

• Stefan Lundin, MD PhD

  Dept of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 10, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

SE (1)