Trial document




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  DRKS00004204

Trial Description

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Title

Time of an ICU diary

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Intensive Care diaries are diaries that are written by family members and nurses of ICU patients to enable them to understand the period of unconsciousness.
It is unclear how much time is needed for writing a diary by nurses.
The study covers the time in minutes and seconds to determine the average time.

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Brief Summary in Scientific Language

Background
diaries are written for intensive care patients patients during the period of mechanical ventilation and sedation by nurses and members. ICU diaries reduce the incidence of post-traumatic stress disorder, depression and anxiety and quality of life of patients and their families.

Problem
The problem in the implementation of the ICU diary is the argument that writing a diary would take too much time. So far there is no study that has captured the actual amount of time for writing a diary. Questions are therefore: how much time nurses need to write an entry in a diary? Can this time be reduced by training and experience?

Methodology
It is a quantitative, exploratory, prospective, multicenter, non-experimental observational study. Nurses collect the time in minutes and seconds they need to write a diary.
participants are ICU nurses who have already implemented the diary. Participants will be recruited on the basis of voluntary, informed consent by an international network that was initiated the study leader in 2012 (Australia, Denmark, Germany, England, Ireland, Norway, Austria, Sweden, Switzerland, USA).
Endpoint is the time required for the acquisition of 30 Intensive diaries and / or over a period of 6 months.
The study will not collect any patient information or other personal information. The study is accepted by the Ethics Committee of the Christian Albrecht University of Kiel (D436/12)

Evaluation
Descriptive statistical analysis and variance analysis using SPSS.

Aim & purpose
The study determines the average time that is needed to write an ICU diary and cost-benefit analyzes will be possible. In addition, the results support the further implementation of the intensive diary in intensive care.

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Organizational Data

  •   DRKS00004204
  •   2012/06/29
  •   [---]*
  •   yes
  •   Approved
  •   436/12, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Conditions, that require a treatment on an intensive care unit
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Interventions/Observational Groups

  •   Nurses, who write diaries for patients on Intensive Care Unit
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The time that a nurse needs for a single entry in a diary, recorded in minutes and seconds

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Secondary Outcome

Number of disturbances while writing a diary, nurse to patient ratio, experience in writing diaries

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
  •   United Kingdom
  •   Sweden
  •   Indonesia
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2012/07/01
  •   7
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Intensive Care Unit that write diaries for patients

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Exclusion Criteria

Hospice or palliative wards

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Addresses

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    • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Neurologie, neurol. Intensivstation & Stroke Unit N1
    • Mr.  Peter  Nydahl 
    • Schittenhelmstr. 10
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Neurologie, neurol. Intensivstation & Stroke Unit N1
    • Mr.  Peter  Nydahl 
    • Schittenhelmstr. 10
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Neurologie, neurol. Intensivstation & Stroke Unit N1
    • Mr.  Peter  Nydahl 
    • Schittenhelmstr. 10
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Neurologie, neurol. Intensivstation & Stroke Unit N1
    • Mr.  Peter  Nydahl 
    • Schittenhelmstr. 10
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/31
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Trial Publications, Results and other Documents

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