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

December 19, 2022 updated by: Jeanne et Leon Developpement

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1: "intervention" group, named "Group 3+"
attend at least three workshops per week
Other: 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.
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 8 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of each item of the scores Short Form 36 self questionnaire
Time Frame: 15 months
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
Time Frame: 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)
Time Frame: 15 months

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

no scores: answers yes/no to different items
15 months
Evolution of intercurrent health events of the composite score FRAQOL at one, three and six months after the end of the program
Time Frame: 15 months
Evolution of intercurrent health events of the composite score FRAQOL at one, three and six months after the end of the program The objective is to estimate the frequency of occurrence of intercurrent health events of the composite score FRAQOL
15 months
Estimation of the incremental cost associated with the occurrence of intercurrent events up to six months after program completion
Time Frame: 15 months
Estimation of the incremental cost associated with the occurrence of intercurrent events up to six months after program completion
15 months
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.
Time Frame: 15 months
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.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeanne et Leon Developpement

Collaborators

Gerontopôle des Pays de la Loire

Investigators

  • Study Director: Gilles BERRUT, Pr, Gerontopôle des Pays de la Loire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Anticipated)

January 20, 2024

Study Completion (Anticipated)

April 20, 2024

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-S01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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