Intensive Care Unit SyndromeNCT02767180
Evaluation of an ICU-specific Questionnaire for Patient-reported Outcome Measures
An observational study of Intensive Care Unit Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit Syndrome
- How many people
- 800 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2016to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient with acute neurological/neurosurgical conditions and/or anoxic/hypoxic brain damage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Intensive Care Specific Questionnaire for Patient-reported Outcome
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.
Read the 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.
- Conditions
- Intensive Care Unit Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months to 3 years after intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startApr 2016
- Primary completion1 Apr 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Lundin, Sahlgrenska University Hospital
- Investigators
- Stefan Lundin, MD PhD, Principal investigator, Dept of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767180
- Sponsor's protocol ID
- LUA-74200
- Status last verified
- Oct 2020
- First submitted
- 28 Apr 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24088092Johannesson 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.
PubMed 39462425Malmgren 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.
PubMed 38553749Malmgren 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.
PubMed 33632271
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intensive Care Specific Questionnaire for Patient-reported Outcome
- ClinicalTrials.gov ID
- NCT02767180
- Acronym / sponsor ID
- LUA-74200
- Conditions
- Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient with acute neurological/neurosurgical conditions and/or anoxic/hypoxic brain damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient reported outcome measured with an ICU-specific questionnaire
Time frame: Six months to 3 years after intensive care
An ICU-specific questionnaire will be used which has been developed from interviews of former ICU-patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Results publication: PubMed 24088092Pandharipande 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.
- Derived from this study: PubMed 39462425Johannesson 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.
- Derived from this study: PubMed 38553749Malmgren 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.
- Derived from this study: PubMed 33632271Malmgren 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Lundin, MD PhD principal investigator
Dept of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported outcome measured with an ICU-specific questionnaire (time frame: Six months to 3 years after intensive care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02767180, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.