Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
时间窗: 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
次要结局
- Evolution of each item of the Step 1 of ICOPE(Integrated Care for Older People)(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(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)
- 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)