Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT05659706
Status:
UNKNOWN
Last Update Posted:
2022-12-21
First Post:
2022-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
Sponsor:
Jeanne et Leon Developpement
Organization:
Study Overview
Official Title:
Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRAQOL
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: