Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary

NCT05659706 | Unknown

• 1 other identifier: 21-S01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Residents's Frailty in Temporary Accommodation; Residents's Quality of Life in Temporary Accommodation

Keywords

Frailty; Quality of life; Health event

Outcome Measures

Primary Outcomes (1)

• 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).

  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). The Short Physical Performance Battery (SPPB) composite test and Short Form 36 (SF-36) self questionnaire will be assessed within 96 hours of admission to the residence, prior to program implementation, and then 3 weeks after the initial assessment SPPB: minimum value = 0 ; maximum value = 12 SPPB 0-6= Low performance SPPB 7-9 =Intermediate intermédiaires SPPB 10-12 =High performance SF36: minimum value = 0 ; maximum value = 100

  8 months

Secondary Outcomes (6)

• Evolution of each item of the scores Short Form 36 self questionnaire

  15 months

• Evolution of each item of the scores Short Physical Performance Battery (SPPB) composite test

  15 months

• Evolution of each item of the Step 1 of ICOPE(Integrated Care for Older People)

  15 months

• Evolution of intercurrent health events of the composite score FRAQOL at one, three and six months after the end of the program

  15 months

• Estimation of the incremental cost associated with the occurrence of intercurrent events up to six months after program completion

  15 months

Study Arms (2)

Arm 1: "intervention" group, named "Group 3+"

attend at least three workshops per week

Other: cognitive evaluations and non cognitive evaluations

Arm 2: "control" group, named "Group 0-1"

not participate in the activities program or will attend a maximum of one workshop per week.

Other: cognitive evaluations and non cognitive evaluations

Interventions

cognitive evaluations and non cognitive evaluations OTHER

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 1: "intervention" group, named "Group 3+"; Arm 2: "control" group, named "Group 0-1"

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeanne et Leon Developpement: lead
• Gerontopôle des Pays de la Loire: collaborator

Study Sites (1)

Résidence les Tamaris- Jeanne et Léon Développement

Bois-de-Céné, 85710, France

RECRUITING

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MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilles BERRUT, Pr

  Gérontopôle des Pays de la Loire

  STUDY DIRECTOR

Central Study Contacts

Manon PONDJIKLI

CONTACT

+33975121125; manon.pondjikli@gerontopole-paysdelaloire.fr

Valentine DUTHEILLET DE LAMOTHE

CONTACT

+33631114945; valentine.dutheillet-de-lamothe@gerontopole-paysdelaloire.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 21, 2022
• Study Start: October 20, 2022
• Primary Completion: January 20, 2024
• Study Completion: April 20, 2024
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)