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

NCT ID: NCT02767180

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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ICU-patients were interviewed in a semi-structured way, providing detailed information on symptoms and difficulties in all areas of everyday life. The interviews were recorded, transcribed, and the issues were categorized into 13 hypothesised domains.All issues were then rephrased into questions, with care taken to maintain only one issue per question, and adequate scales for frequency, intensity and duration was used. The time frame is usually the last month. This intensive care 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

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Intensive Care Unit Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Critical care survivors

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

No interventions assigned to this group

Matched controls

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patient with acute neurological/neurosurgical conditions and/or anoxic/hypoxic brain damage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stefan Lundin

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Lundin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 24088092 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39462425 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38553749 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33632271 (View on PubMed)

Other Identifiers

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LUA-74200

Identifier Type: -

Identifier Source: org_study_id

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