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Health and Quality of Life One Year After Discharge From the Intensive Care Unit (ICU) (QoL_ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671916
Recruitment Status : Terminated (insufficient number of replies by patients)
First Posted : February 2, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Cristoph Haberthür, Klinik Hirslanden, Zurich

Tracking Information
First Submitted Date August 17, 2015
First Posted Date February 2, 2016
Last Update Posted Date March 6, 2019
Study Start Date January 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2016)
Survival [ Time Frame: 1 year after ICU discharge ]
Original Primary Outcome Measures
 (submitted: January 29, 2016)
  • Quality of Life (SF-12) [ Time Frame: 1 year after ICU discharge ]
    evaluated by questionnaire SF-12
  • Survival [ Time Frame: 1 year after ICU discharge ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health and Quality of Life One Year After Discharge From the Intensive Care Unit (ICU)
Official Title Health and Quality of Life One Year After Discharge From the ICU: in Time Not Limited Quality Control After Intensive Medical Treatment
Brief 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.
Detailed Description no detailled description necessary
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population all patients with conditions that lead to an ICU stay
Condition Critically Ill
Intervention Behavioral: questionnaire
Investigation on all study patients, no Intervention, no groups
Study Groups/Cohorts all patients
questionnaire for patients with ICU stay at least 5 days or longer without interruption at the ICU
Intervention: Behavioral: questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 4, 2019)
55
Original Estimated Enrollment
 (submitted: January 29, 2016)
1500
Actual Study Completion Date December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients who are at least 5 days or longer without interruption at the ICU

Exclusion Criteria:

  • patients with less than 4 days at the ICU
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02671916
Other Study ID Numbers QOL_2015_HIRS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Prof. Dr. med. Cristoph Haberthür, Klinik Hirslanden, Zurich
Study Sponsor Prof. Dr. med. Cristoph Haberthür
Collaborators Not Provided
Investigators
Principal Investigator: Christoph Haberthür, MD Klinik Hirslanden, Zurich
PRS Account Klinik Hirslanden, Zurich
Verification Date March 2019