NCT02814773|Completed
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Sponsor study identifier
observational
310
1 country
1
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
June 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 2008
Actual (reported)June 2009
Actual (reported)June 16, 2016
Actual (reported)June 28, 2016
Actual (reported)The psychometric properties of QoL-AD and DQoL measured by questionnaire
30 months
group suffering from Alzheimer-type dementia (mild to moderate dementia)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients included were recruited in centres with a memory clinic or a geriatric ward.
Chu Reims
France, Reims, 51092, France
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.
310 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2016
First Posted
June 28, 2016
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Implementation Study of Dementia Guidelines in Primary Care
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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.
Primary Completion
November 2008
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
September 26, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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