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Comparison of Two Modes of Administration of the IADL Questionnaire, Assessing the Level of Functional Autonomy of Patients to Carry Out the Tasks of Daily Living: Randomized Controlled Trial Among Patients of a Memory Clinic (IADL)

Primary Purpose

Alzheimer's Disease, Dementia Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IADL administration by phone
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease focused on measuring Alzheimer's disease or related disorders, Functional autonomy level, Lawton Instrumental Activities of Daily Living, The Functional autonomy level

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospices Civils de Lyon - Hôpital Charpennes - Memory Research Centre Lyon, Clinical Research Centre (CVF)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Face-to-face collection followed by collection by phone

Collection by phone followed by face-to-face collection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Consistency of the answers to each question of the IADL questionnaires between the two methods of administration
To assess the reliability of the collection of the questionnaire by phone (agreement answers to each question on the IADL), the secondary endpoint will be considered: - The consistency of the answers to each question of the IADL questionnaires between the two methods of administration: during the face-to-face interview, and by phone.

Full Information

First Posted
January 11, 2016
Last Updated
May 19, 2016
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02654574
Brief Title
Comparison of Two Modes of Administration of the IADL Questionnaire, Assessing the Level of Functional Autonomy of Patients to Carry Out the Tasks of Daily Living: Randomized Controlled Trial Among Patients of a Memory Clinic
Acronym
IADL
Official Title
Comparison of Two Modes of Administration of the IADL Questionnaire
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia Disorders
Keywords
Alzheimer's disease or related disorders, Functional autonomy level, Lawton Instrumental Activities of Daily Living, The Functional autonomy level

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Face-to-face collection followed by collection by phone
Arm Type
Experimental
Arm Description
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.
Arm Title
Collection by phone followed by face-to-face collection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
IADL administration by phone
Intervention Description
The administration of IADL questionnaire by phone consists of a collection of answers given by the caregiver during the interview with the research nurse, trained for this procedure. This method of procurement will be standardized with a listing support for the phone interview to obtain the same conditions for collection of data from a caregiver to another. Questions will be asked in the same order than the questionnaire collected with the reference procedure i.e. face-to-face interview at the Memory Clinic. The IADL questionnaires in paper format used during the ace-to-face interview and by phone will be identical.
Primary Outcome Measure Information:
Title
Degree of agreement (concordance) of the overall level of functional autonomy measured with two ways (face-to-face interview and by phone)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Consistency of the answers to each question of the IADL questionnaires between the two methods of administration
Description
To assess the reliability of the collection of the questionnaire by phone (agreement answers to each question on the IADL), the secondary endpoint will be considered: - The consistency of the answers to each question of the IADL questionnaires between the two methods of administration: during the face-to-face interview, and by phone.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Charpennes - Memory Research Centre Lyon, Clinical Research Centre (CVF)
City
Villeurbanne
ZIP/Postal Code
69100
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32169093
Citation
Dauphinot V, Boublay N, Moutet C, Achi S, Bathsavanis A, Krolak-Salmon P. Comparison of Instrumental Activities of Daily Living assessment by face-to-face or telephone interviews: a randomized, crossover study. Alzheimers Res Ther. 2020 Mar 13;12(1):24. doi: 10.1186/s13195-020-00590-w.
Results Reference
derived

Learn more about this trial

Comparison of Two Modes of Administration of the IADL Questionnaire, Assessing the Level of Functional Autonomy of Patients to Carry Out the Tasks of Daily Living: Randomized Controlled Trial Among Patients of a Memory Clinic

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