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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 20 August 2018
Main ID:  NCT02931851
Date of registration: 11/10/2016
Prospective Registration: No
Primary sponsor: Medical University of Graz
Public title: Family Information Management in the Intensive Care Unit ICU-Families
Scientific title: Family Information Management in the Intensive Care Unit: A Randomized Controlled Trial
Date of first enrolment: May 1, 2015
Target sample size: 110
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Austria Switzerland
Name:     Magdalena Hoffmann, MA, MSc, MBA
Telephone: +4331638582383
Name:     Karin Amrein, MD, MSc
Affiliation:  Medical University of Graz
Key inclusion & exclusion criteria

Inclusion Criteria:

- anticipated further ICU stay =3 days (index patient)

Exclusion Criteria:

- lack of Basic Information Technology (IT) user knowledge or German language skills

- DNR (Do not resuscitate) orders (index patient)

Age minimum: 18 Years
Age maximum: 100 Years
Gender: All
Health Condition(s) or Problem(s) studied
Extended Family
Other: ICU Families Website
Other: Placebo
Primary Outcome(s)
Subjective distress [Time Frame: 30 Days]
Secondary Outcome(s)
Length of stay [Time Frame: 90 days]
Levels of anxiety and depression [Time Frame: 30 days]
Mortality [Time Frame: 90 days]
Readmissions [Time Frame: 90 days]
Subjective usefulness of the website for relatives [Time Frame: 30 days]
User-statistics [Time Frame: 30 days]
Secondary ID(s)
ICU-Families 1.0
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Medical University of Vienna
University Hospital Inselspital, Berne
Ethics review
Results available:
Date Posted:
Date Completed:
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