|
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: |
NCT00450034 |
|
Date of registration:
|
19/03/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)
OMAGE |
|
Scientific title:
|
Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial |
|
Date of first enrolment:
|
April 2007 |
|
Target sample size:
|
665 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00450034 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Sylvie LEGRAIN, MD,PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Assistance Publique - Hôpitaux de Paris |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients hospitalized as a matter of urgency in unity(unit) of geriatrics acute
- Patients of more than 70 years old
- Hospitalization in the Unity(Unit) of Geriatrics foreseen(planned) superior acute in
5 days
- enlightened assent writing and signed
- preliminary medical examination
Exclusion Criteria:
- Patients in scheduled(programmed) hospitalization
- Patient in palliative care
- Patient whose vital forecast is engaged(opened) in 3 months
- Patient already include during a previous hospitalization Patient already included in
a study concerning the therapeutic care
- Followed medical impossible (refusal of care, absence of alive regular, patient
doctor abroad)
- not membership to a regime of Social Security or CMU
- Patient not speaking French
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Global Medical Assessment of Elderly Frail Patients
|
|
Intervention(s)
|
|
Procedure: drug - oriented multifaceted intervention
|
|
Primary Outcome(s)
|
|
Rate of unplanned readmissions, including emergency consultations,
[Time Frame: during the study]
|
|
Secondary Outcome(s)
|
|
Data collected at 3 and 6 months
[Time Frame: at 3 and 6 months]
|
|
delay before readmission,
[Time Frame: before readmission]
|
|
number of drug events related readmissions.
[Time Frame: readmissions]
|
|
Mortality at 6 months,
[Time Frame: at 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|