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

S

Sahlgrenska University Hospital

Status

Completed

Conditions

Intensive Care Unit Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT02767180
LUA-74200

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

800 participants in 2 patient groups

Critical care survivors
Description:
Former ICU-patients recruited six months to three years after discharge from the ICU
Matched controls
Description:
Control patients who have not been critically ill, matched for age and sex.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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