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Family Information Management in the Intensive Care Unit (ICU-Families)

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: NCT02931851
Recruitment Status : Suspended
First Posted : October 13, 2016
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
Medical University of Vienna
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:

Relatives in intensive care units (ICU) are important partners in decision-making in the treatment of critically ill patients and provide a significant resource in the care and recovery of patients. Therefore, a professional, educational intervention targeting these caregivers may have fundamental benefits with little risk. As in other fields, information is searched in the internet, but this unselected information is often overwhelming and of little use in this context.

Symptoms of anxiety, stress and depression are common in affected relatives. The majority of family members report some level of anxiety, depression and stress, sometimes even resulting in post-traumatic stress disorder (PTSD). Importantly, an association between lack of information and post-traumatic stress disorder PTSD has been reported. The large number of potentially affected families poses a particular challenge to healthcare and may cause substantial secondary costs to national economy.


Condition or disease Intervention/treatment Phase
Extended Family Other: ICU Families Website Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family Information Management in the Intensive Care Unit: A Randomized Controlled Trial
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Placebo Comparator: Placebo
Standard Information
Other: Placebo
Standard Information provided online

Active Comparator: Intervention
Professionally developed website for relatives of ICU patients
Other: ICU Families Website
Professionally developed website for relatives of ICU patients




Primary Outcome Measures :
  1. Subjective distress [ Time Frame: 30 Days ]
    Impact of Event Score (IES: symptoms of post traumatic stress disorder)


Secondary Outcome Measures :
  1. Levels of anxiety and depression [ Time Frame: 30 days ]
    Measured by Hospital Anxiety and Depression Score (HADS)

  2. Subjective usefulness of the website for relatives [ Time Frame: 30 days ]
    Subjective Evaluation

  3. Length of stay [ Time Frame: 90 days ]
    ICU and Hospital length of stay of the index patients

  4. Readmissions [ Time Frame: 90 days ]
    number of readmissions of the index patients

  5. Mortality [ Time Frame: 90 days ]
    mortality of the index patients

  6. User-statistics [ Time Frame: 30 days ]
    user statistics for the website



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931851


Locations
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Austria
Medical University of Graz
Graz, Austria, 8036
Medical University of Vienna
Vienna, Austria
Switzerland
University of Berne - Inselspital
Bern, Switzerland
Sponsors and Collaborators
Medical University of Graz
Medical University of Vienna
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Karin Amrein, MD, MSc Medical University of Graz
Publications:
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02931851    
Other Study ID Numbers: ICU-Families 1.0
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No