Clinical trial NCT05659706: Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
Official title: Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Residents's Frailty in Temporary Accommodation
Residents's Quality of Life in Temporary Accommodation
Keywords: Frailty
Quality of life
Health event
Lead sponsor: Jeanne et Leon Developpement
Sponsor class: OTHER
Collaborators: name: Gerontopôle des Pays de la Loire
First posted: 2022-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will focus on elderly people (men and women) living in temporary accommodation in the Résidence Les Tamaris.

It will take place in the residents' living quarters.

Brief summary: The management of frailty is a difficulty in the Temporary Accommodation Residences. Frailty represents a risk of reducing the activities of the elderly person. Jeanne \& Léon Développement® offers an activity program that integrates several dimensions (physical and/or nutritional and/or social and/or psychological). To obtain the expected benefit, effect of the Jeanne \& Léon® activities program on the residents's frailty and quality of life in temporary accommodation, the activity of at least one of these approaches is used as a global stimulant and thus activates the remaining skills to help fight against the frailty syndrome. In order to do this, the framework of the temporary accommodation, the group dynamics and the presence of a professional facilitator ensure the conditions for adherence to the program and promote the realization of stimulating activities.

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: The clinical assessment will be performed by the investigating physician.

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.

Eligibility criteria: Inclusion Criteria:

* Aged 60 years and over
* 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:

* Refusal to participate by the resident, family member or designated support person
* Communication difficulties, sensory and/or motor deficits
* Medical contraindication
* Participant already included in another research protocol
* Person under legal protection

Primary outcomes:
measure: The endpoint will be a composite score, the FRAQOL, based on a combination of functional performance assessment (Short Physical Performance Battery (SPPB) composite test) and Quality of Life (Short Form 36 (SF-36) self questionnaire).
timeFrame: 8 months
Secondary outcomes:
measure: Evolution of each item of the scores Short Form 36 self questionnaire
timeFrame: 15 months
measure: Evolution of each item of the scores Short Physical Performance Battery (SPPB) composite test
timeFrame: 15 months
measure: Evolution of each item of the Step 1 of ICOPE(Integrated Care for Older People)
timeFrame: 15 months
measure: Evolution of intercurrent health events of the composite score FRAQOL at one, three and six months after the end of the program
timeFrame: 15 months
measure: Estimation of the incremental cost associated with the occurrence of intercurrent events up to six months after program completion
timeFrame: 15 months
measure: Use of the ICOPE screening questionnaire responses as a descriptive element of the study population and analysis of a potential predictive relationship on the 6-month outcome.
timeFrame: 15 months
Other outcomes:
Locations:
city: Bois-de-Cené
country: France
facility: Résidence les Tamaris- Jeanne et Léon Développement
Study officials:
affiliation: Gérontopôle des Pays de la Loire
name: Gilles BERRUT, Pr
role: STUDY_DIRECTOR
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