Critically IllQoL_ICUNCT02671916
Health and Quality of Life One Year After Discharge From the Intensive Care Unit (ICU)
An observational study of Critically Ill, run by Prof. Dr. med. Cristoph Haberthür at 1 site in Switzerland.
Trial summary
The goal is to capture the Quality of life and survival of patients one year after the stay at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the ICU stay patients will be send a Quality of Life questionnaire they need to fill out and return. All data will be evaluated together. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critically Ill
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Dec 2018
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with conditions that lead to an ICU stay
Who may be able to join
- patients who are at least 5 days or longer without interruption at the ICU
Who cannot join
- patients with less than 4 days at the ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health and Quality of Life One Year After Discharge From the ICU: in Time Not Limited Quality Control After Intensive Medical Treatment
The goal is to capture the Quality of life and survival of patients one year after the stay at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the ICU stay patients will be send a Quality of Life questionnaire they need to fill out and return. All data will be evaluated together.
Read the detailed description
no detailled description necessary
- Conditions
- Critically Ill
- Being tested
- questionnaire
- Keywords
- QoL and Survival one year after ICU stay
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
Investigation on all study patients, no Intervention, no groups
| Study group | Role | What they receive |
|---|---|---|
| all patients | questionnaire for patients with ICU stay at least 5 days or longer without interruption at the ICU Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 year after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: insufficient number of replies by patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Cristoph Haberthür
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Cristoph Haberthür, Klinik Hirslanden, Zurich
- Investigators
- Christoph Haberthür, MD, Principal investigator, Klinik Hirslanden, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671916
- Sponsor's protocol ID
- QOL_2015_HIRS
- Acronym
- QoL_ICU
- Status last verified
- Mar 2019
- First submitted
- 17 Aug 2015
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Quality of Life One Year After Discharge From the ICU: in Time Not Limited Quality Control After Intensive Medical Treatment
- ClinicalTrials.gov ID
- NCT02671916
- Acronym / sponsor ID
- QoL_ICU / QOL_2015_HIRS
- Conditions
- Critically Ill
- Keywords
- QoL and Survival one year after ICU stay
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient number of replies by patients
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Prof. Dr. med. Cristoph HaberthürUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Feb 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.
The goal is to capture the Quality of life and survival of patients one year after the stay at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the ICU stay patients will be send a Quality of Life questionnaire they need to fill out and return. All data will be evaluated together.
Detailed description
no detailled description necessary
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | – | Behavioral: questionnairequestionnaire for patients with ICU stay at least 5 days or longer without interruption at the ICU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with conditions that lead to an ICU stay
Key inclusion criteria (1 listed)
- patients who are at least 5 days or longer without interruption at the ICU
Key exclusion criteria (1 listed)
- patients with less than 4 days at the ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireInvestigation on all study patients, no Intervention, no groups | Behavioural | all patients |
Primary outcome
Survival
Time frame: 1 year after ICU discharge
Results and safety
The study was stopped early (reason given: insufficient number of replies by patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Christoph Haberthür, MD principal investigator
Klinik Hirslanden, Zurich
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 Critically Ill, run by Prof. Dr. med. Cristoph Haberthür at 1 site in Switzerland.
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 1 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: stopped early, as of the sponsor's last update on 6 Mar 2019. 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 Switzerland. 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 was stopped early (reason given: insufficient number of replies by patients). Results are not available in the source record.
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?
Survival (time frame: 1 year after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2019.