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Performance Evaluation Platform for Seniors. (PEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522401
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief Summary:
Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.

Condition or disease Intervention/treatment
Aging Diagnostic Test: consultation: "Bien vieillir"

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 Design
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Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of the Loss of Autonomy in the Old People: Factors Favoring or Limiting the Respect of Recommendations
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Diagnostic Test: consultation: "Bien vieillir"
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Overall rate of implementation of the recommendations at 9 months [ Time Frame: Months: 9 ]
    Analysis by tracking sheet patient results.

  2. Satisfaction rate of the platform's users [ Time Frame: Months: 9 ]
    Analysis by qualitative interviews results.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
seniors who have had a gerontological assessment
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522401


Locations
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France
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Étienne, France, 42270
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Romain JUGAND, MD CHU SAINT-ETIENNE
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04522401    
Other Study ID Numbers: 2018-A01075-50 (RIPH3)
2018-A01075-50 ( Other Identifier: ANSM )
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
old people
gerontological assessment
loss of autonomy