Evaluation of the Quality of Life in the Elderly With Dementia : Validation of a Specific Instrument
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| ClinicalTrials.gov Identifier: NCT02814773 |
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Recruitment Status :
Completed
First Posted : June 28, 2016
Last Update Posted : September 26, 2016
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| Condition or disease | Intervention/treatment |
|---|---|
| Dementia | Other: questionnaires |
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 |
| Actual Enrollment : | 310 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of the Quality of Life in the Elderly With Dementia : Validation of a Specific Instrument |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | June 2009 |
| Group/Cohort | Intervention/treatment |
|---|---|
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AD group
group suffering from Alzheimer-type dementia (mild to moderate dementia)
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Other: questionnaires |
- The psychometric properties of QoL-AD and DQoL measured by questionnaire [ Time Frame: 30 months ]
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814773
| France | |
| Chu Reims | |
| France, Reims, France, 51092 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | CHU de Reims |
| ClinicalTrials.gov Identifier: | NCT02814773 |
| Other Study ID Numbers: |
112N04 |
| First Posted: | June 28, 2016 Key Record Dates |
| Last Update Posted: | September 26, 2016 |
| Last Verified: | September 2016 |
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Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |