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临床试验/NCT02654574
NCT02654574已完成不适用

Comparison of Two Modes of Administration of the IADL Questionnaire

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2014年6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
299
试验地点
1
主要终点
Degree of agreement (concordance) of the overall level of functional autonomy measured with two ways (face-to-face interview and by phone)

研究概览

简要总结

In France, about 1 million people 65 and older are diagnosed with dementia syndrome characterized by cognitive decline and impairment of functional capacity. The assessment of the level of functional autonomy is therefore an essential step in monitoring patients in Memory Clinic and can be estimated by the Lawton IADL questionnaire, assessing the patients' ability to perform daily tasks.

In the Memory Clinic, the first estimate of the level of patient autonomy is achieved during a face-to-face interview between their primary caregiver and a nurse, using the IADL questionnaire. This assessment should be renewed every year. The IADL questionnaire is part of the information that the memories consultations shall transmit to the Alzheimer's National Bank (BNA).

However, current practice has shown that the systematic collection is problematic in the organization of Memory Clinic. It is thus expected to collect this questionnaire by phone in order to measure changes in the level of autonomy during the disease, and improve the completeness of this collection. A study is conducted with the main objective to measure the reliability of the assessment of IADL questionnaires conducted during a telephone interview with the caregiver of the patient, in comparison to the reference mode: the face-to-face interview with the caregiver.

Materials and methods The experimental design of the study will be a randomized crossover trial (crossover), including 394 patients divided into two branches. In the first part, the collection of the IADL questionnaire will be performed according to the reference method in the consultation (face-to-face interview with the nurse), the measurement will be repeated at 1 month intervals by phone. In the second part the sequence of execution modes will be reversed. The reliability of the measurement of the level of autonomy will be studied by comparing repeated measurements based on handover modes. The correspondence between the repeated measures will also be considered in terms of patient characteristics. The feasibility of administration of the questionnaire by phone mode will be evaluated.

Expected results The mode of administration by phone should allow to obtain a reliable measurement of the level of patient autonomy when the administration is carried out in a standardized way. The study should also identify patients and situations for which this method of administration by phone may be appropriate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Patients received for the first time at the Memory Clinic,
  • Patients living at home
  • Patients accompanied by a caregiver,
  • Patients and caregivers agreeing to participate in the study.

排除标准

  • Patients whose caregivers did not wish to participate in the study,
  • Patients living in institutions or nursing homes,
  • Patients whose caregivers did not have or did not provide a telephone contact,
  • Patients for who the health status would require institutionalization during the period of the study.

研究组 & 干预措施

Face-to-face collection followed by collection by phone

Experimental

Reference procedure i.e IADL collected during a face-to-face interview at the Memory Clinic, followed by the collection of IADL by phone, one month later.

干预措施: IADL administration by phone (Other)

Collection by phone followed by face-to-face collection

Experimental

Collection of IADL by phone, followed by the collection of the IADL questionnaire using the reference procedure i.e IADL collected during a face-to-face interview at the Memory Clinic, one month later.

干预措施: IADL administration by phone (Other)

结局指标

主要结局

Degree of agreement (concordance) of the overall level of functional autonomy measured with two ways (face-to-face interview and by phone)

时间窗: 1 month

The degree of agreement (concordance) of the overall level of autonomy will be measured between the two modes administration of the IADL questionnaire. The level of independence (or dependence) will be evaluated from the scale of instrumental activities of daily living (IADL Lawton). From 8 issues, it allows to study the ability of the person to perform common activities: Ability to use the phone to go shopping, preparing food, do its housekeeping, to its activities bleaching, to use the means of transport, to ensure accountability in respect of salary and handle money.

次要结局

  • Consistency of the answers to each question of the IADL questionnaires between the two methods of administration(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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