Evaluation of the Quality of Life in the Elderly With Dementia : Validation of a Specific Instrument

September 22, 2016 updated by: CHU de Reims
With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and related syndromes are a major public health issue. The lake of drug for treatment or preventing AD, health related quality of life (HRQoL) became an essential criterion of evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally less sensitive for a given disease. That is why other specific tools for AD have been developed. None of them was validated in French. The aim of this study was therefore, after a review of the literature, to achieve a cross-cultural adaptation and psychometric validation of the "Quality of Life in Alzheimer's Disease" (QoL-AD) and "Dementia Quality of Life" (DQoL). These two questionnaires were selected because they were the most popular in English- language literature for this disease.This study concerned a total of 155 patient-caregiver pairs recruited from six French hospitals and a Francophone Swiss center. Patients had a confirmed diagnosis of AD (mild stage to moderate: Mini Mental State Examination ≥ 10). QoL-AD and DQoL were administered by an interviewer. The caregiver sheet of QoL-AD was self-administered. Cross-cultural adaptation and psychometric validation have been carried out for these two questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and related syndromes are a major public health issue. The lake of drug for treatment or preventing AD, health related quality of life (HRQoL) became an essential criterion of evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally less sensitive for a given disease. That is why other specific tools for AD have been developed. None of them was validated in French. The aim of this study was therefore, after a review of the literature, to achieve a cross-cultural adaptation and psychometric validation of the "Quality of Life in Alzheimer's Disease" (QoL-AD) and "Dementia Quality of Life" (DQoL). These two questionnaires were selected because they were the most popular in English- language literature for this disease.This study concerned a total of 155 patient-caregiver pairs recruited from six French hospitals and a Francophone Swiss center.

Patients had a confirmed diagnosis of AD (mild stage to moderate: Mini Mental State Examination ≥ 10). QoL-AD and DQoL were administered by an interviewer. The caregiver sheet of QoL-AD was self-administered. Cross-cultural adaptation and psychometric validation have been carried out for these two questionnaires. First step: the linguistic adaptation will be performed according to the latest available methodology: that of the " Institute for Work and Health ", as recommended 6 phases. Second step: the psychometric validation will be done after a multicentric study, cross repeated at weekly intervals for the validation phase , with two longitudinal points for the assessment phase of sensitivity to change. Analysis of the results will help define the applicability criteria and psychometric acceptability to know the validity of the adapted instrument that is to say, its content validity , validity of perceived, validity of structure, validity of agreement , its discriminative ability , reliability explored by internal consistency and stability over time. Longitudinal follow-up of patients is expected to also assess the sensitivity to change .

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Reims
      • France, Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients included were recruited in centres with a memory clinic or a geriatric ward.

Description

To be included in the study, patients had to be :

  • 65 years or older;
  • native French speakers;
  • living at home or in an institution;
  • suffering from Alzheimer-type dementia defined according to DSM IV criteria, and had to obtain a score of 10 on the MMSE corresponding from mild to moderate dementia
  • to have a main caregiver able to read.

Were not included in the cohort study , patients :

  • From age 65;
  • Achieved an evocative syndrome of dementia is not in accordance with the criteria DSM IV;
  • From a mother tongue other than French;
  • Possessing no help;
  • With a MMSE score <10 , so with severe dementia;
  • Hospitalized in short , medium or long stay;
  • Having refused to participate in the study .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AD group
group suffering from Alzheimer-type dementia (mild to moderate dementia)
Other: questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The psychometric properties of QoL-AD and DQoL measured by questionnaire
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112N04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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