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

Evaluation of an Intensive Care Specific Questionnaire for Patient-reported Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02767180
Enrollment
800
Registered
2016-05-10
Start date
2016-04-30
Completion date
2020-09-01
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Syndrome

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.

Detailed description

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.

Interventions

None listed

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient reported outcome measured with an ICU-specific questionnaireSix months to 3 years after intensive careAn ICU-specific questionnaire will be used which has been developed from interviews of former ICU-patients

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026