Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
NCT ID: NCT05659706
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-10-20
2024-04-20
Brief Summary
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The phenomenon of activation initiated during the residential activity program can lead to an improvement in the components of frailty which is maintained over time. This will be assessed in terms of the occurrence of events after the activity program has been followed.
Detailed Description
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Initial follow-up: Fragility and Quality of Life assessment is carried out by the trained nursing staff (doctor, nurse) of the Résidence Les Tamaris. The clinical assessment will include screening for thymic disorders. All experimenters will be specifically trained in the protocol and GCP beforehand.
V0 (inclusion visit carried out within 72 hours after admission to the residence): inclusion after information and non-opposition, then randomization into the control group or the intervention group V1 (initial assessment visit performed within 96 hours after admission to the residence): initial assessment of the resident V2 (V1+ 21 days +/- 1 day: end of main study visit): final evaluation of the main study.
In case of discharge from the Residence: validation of the contact information and the follow-up telephone schedule of the participant.
Post-program follow-up: identification of intercurrent events by the Residence staff
VS1 (V2 + 1 Month), SV2 (V2 + 3 Months): interview of participants by on-site follow-up or telephone call VS3 (V2 + 6 Months): on-site follow-up or final phone call.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Arm 1: "intervention" group, named "Group 3+"
attend at least three workshops per week
cognitive evaluations and non cognitive evaluations
Mini Mental State Examination Charlson Comorbidity Index Katz Index ICOPE step 1 The 15-item geriatric depression scale (GDS-15) Medical Outcomes Study Short Form 36 (SF-36) Short Physical Performance Battery ( SPPB)
Arm 2: "control" group, named "Group 0-1"
not participate in the activities program or will attend a maximum of one workshop per week.
cognitive evaluations and non cognitive evaluations
Mini Mental State Examination Charlson Comorbidity Index Katz Index ICOPE step 1 The 15-item geriatric depression scale (GDS-15) Medical Outcomes Study Short Form 36 (SF-36) Short Physical Performance Battery ( SPPB)
Interventions
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cognitive evaluations and non cognitive evaluations
Mini Mental State Examination Charlson Comorbidity Index Katz Index ICOPE step 1 The 15-item geriatric depression scale (GDS-15) Medical Outcomes Study Short Form 36 (SF-36) Short Physical Performance Battery ( SPPB)
Eligibility Criteria
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Inclusion Criteria
* Participant who has been living in temporary accommodation at the Résidence Les Tamaris for a maximum of 72 hours
* Visual, auditory and oral or written abilities in French sufficient to complete the assessments and participate in the Jeanne \& Léon® Program activities
* Agrees to participate in the study and follow-ups for up to six months after the end of the activity program/temporary residence
* Non-opposition accompanied by the information note co-signed by the investigator and the resident participating in the study, or the family member or the designated trusted person (if applicable)
* Must be affiliated to a social security plan
Exclusion Criteria
* Communication difficulties, sensory and/or motor deficits
* Medical contraindication
* Participant already included in another research protocol
* Person under legal protection
60 Years
ALL
Yes
Sponsors
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Gerontopôle des Pays de la Loire
OTHER
Jeanne et Leon Developpement
OTHER
Responsible Party
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Principal Investigators
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Gilles BERRUT, Pr
Role: STUDY_DIRECTOR
Gérontopôle des Pays de la Loire
Locations
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Résidence les Tamaris- Jeanne et Léon Développement
Bois-de-Céné, , France
Countries
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Central Contacts
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Facility Contacts
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Christophe BEAUVAIS
Role: primary
Nathalie BEAUVAIS
Role: backup
References
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Other Identifiers
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21-S01
Identifier Type: -
Identifier Source: org_study_id