|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01365377 |
|
Date of registration:
|
31/05/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Impact of Information Strategy Based on Booklet on Anxiety in Family in ICU
FAMILLE |
|
Scientific title:
|
Impact of the Deliverance and Use of a Written Detailed Information Brochure on Anxiety Felt by the Family Members of Patients Admitted in Intensive Care Unit |
|
Date of first enrolment:
|
April 2011 |
|
Target sample size:
|
180 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01365377 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Jean-Jacques ROUBY, MD, PhD |
|
Address:
|
|
|
Telephone:
|
033-142177305 |
|
Email:
|
chunghi.do@psl.aphp.fr |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- All patients admitted in ICU whose previsible length of stay is over 3 days.
Exclusion Criteria:
- Admitted patient without organ failure
- Family member or patient who can't speak and/or read French
- Family who didn't show off within the first week of hospitalization
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Anxiety
|
|
Depression
|
|
Post-traumatic Stress Disorders
|
|
Intervention(s)
|
|
Other: booklet deliverance and use in the process of daily information
|
|
Primary Outcome(s)
|
|
Decreased of the Anxiety Score of 20% in the "brochure arm" from admission to discharge of ICU.
[Time Frame: One year per arm]
|
|
Secondary Outcome(s)
|
|
Assessment of quality of life in patients and relatives
[Time Frame: Two years]
|
|
Diagnostic and following of Post-traumatic stress disorder
[Time Frame: Two years]
|
|
Decreased of Depression Scoring on the HADS
[Time Frame: two years]
|
|
Secondary ID(s)
|
|
FAMILLE-JJR-2
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|