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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02357680 |
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Date of registration:
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03/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Diaries for Critically Ill Patients Written by Relatives
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Scientific title:
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Dagbøger Til Kritisk Syge Patienter Skrevet af pårørende: Betydning for Patient og pårørende Samt Effekt i Forhold Til Udvikling af Symptomer på Posttraumatisk Stress |
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Date of first enrolment:
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March 15, 2015 |
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Target sample size:
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189 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02357680 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Anne H Nielsen, RN, MCN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospitalsenheden Vest |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients:
- Expected to stay in ICU > 48 hours
- Expected to be on ventilator > 24 hours
- Has a close relative > 18 years old
- Speaking and understanding Danish.
- Expected to be able to deliver an informed consent later
Relative:
*Speaking and understanding Danish
Relative and patient are included in the study as a pair.
Exclusion Criteria:
- Patient staying less than 48 hours in ICU
- Patient less than 24 hours on ventilator
- Patient not able to give an informed consent to participate in study or patient dies
in ICU (both relative and patient are excluded).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anxiety
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Stress Disorders, Post-Traumatic
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Depression
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Intervention(s)
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Other: Diary
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Primary Outcome(s)
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PTSS-14 (Post Traumatic Stress Symptoms)
[Time Frame: 3 months post discharge from ICU]
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Secondary Outcome(s)
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HADS (Hospital Anxiety and Depression Scale)
[Time Frame: 3 months post discharge from ICU]
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SF-36
[Time Frame: 3 months post discharge from ICU]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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