- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393299
Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric. (REVOR)
August 4, 2020 updated by: Lille Catholic University
Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric: Study of Superiority, Randomized, Controlled, Prospective, Single Blind
Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Versailles, France, 78004
- Hopital La Porte Verte
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient with more than 75 years old
- Hospitalized in geriatrics short-stay
- Patient with a written informed consent
- Patient with a social security scheme
Exclusion Criteria:
- Severe dementia
- Not able to respond to SF-12
- Disease at final stage
- Patient under legal protection (maintenance of justice, tutelage, legal guardianship)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STOPP/START
Use of STOPP/START criteria during medication reconciliation
|
software which helps to do the drug reconciliation
|
|
No Intervention: CONTROL
Medication reconciliation done as usual, without the consideration of the STOPP/START criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-12 Quality of life scale
Time Frame: at inclusion and at 2 months
|
The evolution of the hospitalised elderly people's quality of life at 2 months will be measured by the SF-12 scale.
|
at inclusion and at 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of falls
Time Frame: at 2 months
|
The number of falls during the two months following the inclusion will be collected for each patient.
|
at 2 months
|
|
Proportion of patients rehospitalized
Time Frame: at 2 months
|
The proportion of patients that have been rehospitalized (unscheduled hospitalization) during the two months following inclusion will be measured.
|
at 2 months
|
|
Mortality
Time Frame: at 2 months
|
The mortality during the two months following inclusion will be measured.
|
at 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2018
Primary Completion (Actual)
July 17, 2018
Study Completion (Actual)
October 30, 2018
Study Registration Dates
First Submitted
January 2, 2018
First Submitted That Met QC Criteria
January 2, 2018
First Posted (Actual)
January 8, 2018
Study Record Updates
Last Update Posted (Actual)
August 5, 2020
Last Update Submitted That Met QC Criteria
August 4, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- RC-P0059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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