- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04522401
Performance Evaluation Platform for Seniors. (PEPS)
Prevention of the Loss of Autonomy in the Old People: Factors Favoring or Limiting the Respect of Recommendations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.
The main objective is to investigate the factors limiting or encouraging adherence to recommendations in a population aged over 65, fragile or pre-fragile, autonomous and living at home or in a shelter.
Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.
Patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day at the day hospital, then at 6 and 9 months. The study will take place over a period of approximately 24 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Saint-Étienne, France, 42270
- Centre Hospitalier Universitaire de Saint-Étienne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Person affiliated or entitled to a social security scheme
- People aged 65 and over who participated in a consultation to age well at the day hospital of the St-Etienne university hospital during the study period.
- Elderly people who received an information about the study and who co-signed, with the investigator, a consent to participate in the study
Exclusion Criteria:
- Seniors who refused to participate
- Elderly people under legal protection measures
- Severe cognitive impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
People aged 65 and over
People aged 65 and over who have had a gerontological evaluation "Bien vieillir" at the St-Etienne University Hospital Day Hospital.
|
Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist.
They will then be exposed to a personalized plan of care in the form of a recommendation.Then, patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day, then at 6 and 9 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of implementation of recommendations concerning mobility (adapted physical activity).
Time Frame: Months: 9
|
This rate is the ratio between the number of mobility recommendations made at 9 months and the number initially recommended. Analysis by tracking sheet patient results. |
Months: 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall rate of implementation of the recommendations at 9 months
Time Frame: Months: 9
|
Analysis by tracking sheet patient results.
|
Months: 9
|
Satisfaction rate of the platform's users
Time Frame: Months: 9
|
Analysis by qualitative interviews results.
|
Months: 9
|
Collaborators and Investigators
Investigators
- Principal Investigator: Romain JUGAND, MD, Chu Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-A01075-50 (RIPH3)
- 2018-A01075-50 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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