NCT02814773

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
Last Updated

September 26, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

June 16, 2016

Last Update Submit

September 22, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • The psychometric properties of QoL-AD and DQoL measured by questionnaire

    30 months

Study Arms (1)

AD group

group suffering from Alzheimer-type dementia (mild to moderate dementia)

Other: questionnaires

Interventions

AD group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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 .

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

France, Reims, 51092, France

Location

Related Publications (4)

  • Wolak A, Novella JA, Drame M, Morrone I, Boyer F, Blanchard F, Jolly D. Is the screening test of the French version of the dementia quality of life questionnaire indispensable? Dement Geriatr Cogn Dis Extra. 2011 Jan;1(1):84-92. doi: 10.1159/000326782. Epub 2011 Apr 6.

  • Wolak A, Novella JL, Drame M, Guillemin F, Di Pollina L, Ankri J, Aquino JP, Morrone I, Blanchard F, Jolly D. Transcultural adaptation and psychometric validation of a French-language version of the QoL-AD. Aging Ment Health. 2009 Jul;13(4):593-600. doi: 10.1080/13607860902774386.

  • Barbe C, Morrone I, Wolak-Thierry A, Drame M, Jolly D, Novella JL, Mahmoudi R. Impact of functional alterations on quality of life in patients with Alzheimer's disease. Aging Ment Health. 2017 May;21(5):571-576. doi: 10.1080/13607863.2015.1132674. Epub 2016 Jan 8.

  • Barbe C, Jolly D, Morrone I, Wolak-Thierry A, Drame M, Novella JL, Mahmoudi R. Factors associated with quality of life in patients with Alzheimer's disease. BMC Geriatr. 2018 Jul 9;18(1):159. doi: 10.1186/s12877-018-0855-7.

MeSH Terms

Conditions

Dementia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 28, 2016

Study Start

May 1, 2006

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

September 26, 2016

Record last verified: 2016-09

Locations