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临床试验/NCT03976661
NCT03976661已完成不适用

Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes

Gérond'if1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Assessment of life quality according Nottingham Health Profile (NHP) scale

研究概览

简要总结

The purpose of this study is to compare life quality of patients taking care by DIAPASON 92 with patients or residents from control group EHPAD (retirement home)

详细描述

This study has two components: a quantitative component(for users and caregivers) and a qualitative component (for users, caregivers and professionals)

About population :

For quantitative component: the investigators have two arms:

  • Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device
  • Control arm: will be constituted by people residing at the EHPAD (retirement home)

For qualitative component: Study will cover 5 different populations since it concerns both:- - Diapason 92 professionals who work directly with users

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient/Resident Inclusion Criteria
  • •Age ≥ 60 years old.
  • •(Group iso-resources) GIR ≤ 4
  • •Beneficiary of treatment by Diapason 92 or resident at EHPAD Aulagnier for more than 6 months.
  • •Not exhibiting severe disruptive behaviour disorders (on NPI-ES all FXG 12 and resonance 4 scores).
  • •Affiliate or entitled to a sickness insurance scheme
  • •Patient or legal representative expressed no objection
  • •Patient/Resident

排除标准

  • •Age < 60 years old
  • •Not affiliated or entitled to a sickness insurance scheme
  • •Patient or legal representative did not express no objection
  • •Professionals and caregivers Inclusion Criteria:
  • •Exercise within Diapason 92 device or be identified as assisting a Diapason 92 user or be a professional partner of Diapason 92 device
  • •Have expressed no objection to participating in the study.

研究组 & 干预措施

DIAPASON 92 arm

Arm will be constitued by older patients with loss of autonomy, living at home benefiting from the device DIAPASON 92 (Innovative support system for elderly people in their homes)

Control arm

Arm will be constituted by people residing at the EHPAD (retirement home)

结局指标

主要结局

Assessment of life quality according Nottingham Health Profile (NHP) scale

时间窗: 12 months

Difference in 12-month quality of life scores (Nottingham Health Profile) between the 2 groups (Diapason 92 and EHPAD).

次要结局

  • Assessment of comorbidity according Charlson scale(12 months)
  • Assessment of activities of daily living, self-care, and independence according Activities of Daily Living (ADL) Scale(12 months)
  • Assessment of the level of loss of autonomy of an elderly people according Autonomy, gerontology Iso Resources Group (AGGIR) scale(12 months)
  • Assessment of functional status according Lawton Instrumental Activities of Daily Living (IADL) Scale(12 months)
  • Assessment of cognitive function according Mini-Mental State Examination (MMSE) scale(12 months)
  • Assessment of geriatric depression according Geriatric Depression Scale (GDS) scale(12 months)
  • Assessment of disorders of disruptive behaviour according (NPI-ES) scale(12 months)
  • Measuring of burden of the close caregivers according Popular Caregiver Self-report measure Burden (ZARIT)(12 months)

研究者

发起方
Gérond'if
申办方类型
Other
责任方
Sponsor

研究点 (1)

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