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临床试验/NCT01796314
NCT01796314已完成不适用

Impact of a Therapeutic Educational Programme for Alzheimer's Disease Patients and Their Caregiver in Community Dwelling, on the AD Patient's Quality of Life

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
Alzheimer's Disease patient's quality of life

研究概览

简要总结

Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.

详细描述

This study is designed to determine whether a therapeutic educational programme for both AD patients, in community dwelling, and their primary caregivers improves patient's quality of life, after two months.

Design : This study is a monocentric randomised controlled intervention trial

Population : One hundred and seventy dyads 'patient-caregiver' in which the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), lives in community dwelling and has a primary caregiver will be included during eighteen months. The primary caregiver is define as a person living with the patient or providing care at least 3 times a week or 8 hours per week; he/she isn't a professional. Eighty five dyad will be include in the intervention group (group A) and eighty five in the control group (group B).

Outcome : Our primary endpoint is the AD patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (Qol-AD) reported by the caregiver at two months.

Our secondary endpoints are caregiver's burden assessed by the Zarit Burden Inventory, frequency and severity of behavioural and psychological symptoms assessed by the Neuro Psychiatric Inventory, independence in personal and instrumental daily life activities assessed by Katz's Activities of Daily Living and Lawton's Instrumental Activities of Daily Living scales, and caregiver's quality of life assessed by the Nottingham Health Profile at 6 months. The patient quality of life will also be recorded at 12 months on the logsdon's Quality of Life in Alzheimer's Disease scale reported, and at every visit (MO, M2, M6, et M12) on the same scale dut (QoL-AD) reported by the patient himself.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26)
  • •in community dwelling
  • •with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week)
  • •is informed and has given his/her consent
  • •whom caregiver is informed and has given his/her consent

排除标准

  • •patient with other type of dementia
  • •living in nursing home or long term care
  • •with no caregiver
  • •not informed or has not given his/her consent
  • •whom caregiver is not informed or has not given his/her consent

研究组 & 干预措施

Group A : intervention

Experimental

85 dyads "patient/caregiver" in witch the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), and lives at home with a caregiver

干预措施: Therapeutic Educational Program (Behavioral)

Group B : Control

No Intervention

There si no associated intervention

结局指标

主要结局

Alzheimer's Disease patient's quality of life

时间窗: 2 months

Alzheimer's Disease patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (QoL-AD) reported by the caregiver

次要结局

  • Caregiver quality of life(2, 6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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