ClinicalTrials.Veeva

Menu

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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Alzheimer's Disease
Dementia Disorders

Treatments

Other: IADL administration by phone

Study type

Interventional

Funder types

Other

Identifiers

NCT02654574
2014-867
2014-A00446-41 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

299 patients

Sex

All

Ages

50+ years old

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

299 participants in 2 patient groups

Face-to-face collection followed by collection by phone
Experimental group
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.
Treatment:
Other: IADL administration by phone
Collection by phone followed by face-to-face collection
Experimental group
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.
Treatment:
Other: IADL administration by phone

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems