DementiaNCT02814773
Evaluation of the Quality of Life in the Elderly With Dementia : Validation of a Specific Instrument
An observational study of Dementia, run by CHU de Reims at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- questionnaires
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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 .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 .
- Conditions
- Dementia
- Being tested
- questionnaires
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| AD group | group suffering from Alzheimer-type dementia (mild to moderate dementia) Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The psychometric properties of QoL-AD and DQoL measured by questionnaire
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMay 2006
- Primary completionNov 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814773
- Sponsor's protocol ID
- 112N04
- Status last verified
- Sep 2016
- First submitted
- 16 Jun 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
Publications
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.
PubMed 22279447Wolak 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.
PubMed 19629785Barbe 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.
PubMed 26745259Barbe 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.
PubMed 29986669
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life in the Elderly With Dementia : Validation of a Specific Instrument
- ClinicalTrials.gov ID
- NCT02814773
- Acronym / sponsor ID
- 112N04
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD group | – | Other: questionnairesgroup suffering from Alzheimer-type dementia (mild to moderate dementia) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients included were recruited in centres with a memory clinic or a geriatric ward.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires | Other | AD group |
Primary outcome
The psychometric properties of QoL-AD and DQoL measured by questionnaire
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Results publication: PubMed 22279447Wolak 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.
- Results publication: PubMed 19629785Wolak 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.
- Results publication: PubMed 26745259Barbe 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.
- Derived from this study: PubMed 29986669Barbe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The psychometric properties of QoL-AD and DQoL measured by questionnaire (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814773, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.