DementiaRiskofADRNCT03623542
Adverse Drug Reactions in Older Subjects
An observational study of Dementia, run by CHU de Reims at 1 site in France.
Trial summary
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation. Design: Longitudinal prospective study from May 2010 to November 2011. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- How many people
- 293 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2010to 1 Nov 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting with dementia syndrome and whose admission was unplanned between May 2010 and November 2011 were consecutively included in the study.
Who may be able to join
- diagnosis of dementia syndrome
- unplanned hospitalisation between may 2010 and november 2011
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation.
Design: Longitudinal prospective study from May 2010 to November 2011. Setting: Dedicated acute geriatric care unit specializing in the management of patients with dementia at the University Hospital of Reims, France.
Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.
Read the detailed description
Introduction: Adverse drug reactions (ADRs) are frequent among older subjects, and are actually avoidable in up to 60% of cases. There are few studies identifying the risk factors for ADRs based on comprehensive geriatric assessment in older subjects with dementia, although better identification of patients at risk could help to target patients at risk for increased morbidity and mortality due to ADRs with a view to taking appropriate preventive measures.
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation.
Design: Longitudinal prospective study from May 2010 to November 2011. Setting: Dedicated acute geriatric care unit specializing in the management of patients with dementia syndrome (Alzheimer disease or related syndromes) at the University Hospital of Reims, France.
Participants: Older patients with dementia syndrome (Alzheimer disease or related syndromes).
Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.
- Conditions
- Dementia
- Keywords
- Dementia, alzheimer dementia
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dementia or alzheimer dementia | All patients presenting with dementia syndrome and whose admission was unplanned between May 2010 and November 2011 were consecutively included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for the occurrence of adverse drug reactions
Factors (as comprehensive geriatric assessment : instrumental activities of daily living scale, Katz's activities of daily living scale, mini nutritional assessment short-form, mini mental state examination) associated with adverse drug reaction
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 May 2010
- Primary completion1 Nov 2011
- Study completion1 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 293 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
- NCT03623542
- Sponsor's protocol ID
- 2017Ao002
- Acronym
- RiskofADR
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kanagaratnam L, Drame M, Novella JL, Trenque T, Joachim C, Nazeyrollas P, Jolly D, Mahmoudi R. Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit. Am J Geriatr Psychiatry. 2017 Mar;25(3):290-296. doi: 10.1016/j.jagp.2016.07.002. Epub 2016 Sep 1.
PubMed 27742527
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit
- ClinicalTrials.gov ID
- NCT03623542
- Acronym / sponsor ID
- RiskofADR / 2017Ao002
- Conditions
- Dementia
- Keywords
- Dementia, alzheimer dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 1 Nov 2011 (actual)
- First posted
- 9 Aug 2018 (actual)
- 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.
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation.
Design: Longitudinal prospective study from May 2010 to November 2011. Setting: Dedicated acute geriatric care unit specializing in the management of patients with dementia at the University Hospital of Reims, France.
Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.
Detailed description
Introduction: Adverse drug reactions (ADRs) are frequent among older subjects, and are actually avoidable in up to 60% of cases. There are few studies identifying the risk factors for ADRs based on comprehensive geriatric assessment in older subjects with dementia, although better identification of patients at risk could help to target patients at risk for increased morbidity and mortality due to ADRs with a view to taking appropriate preventive measures.
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation.
Design: Longitudinal prospective study from May 2010 to November 2011. Setting: Dedicated acute geriatric care unit specializing in the management of patients with dementia syndrome (Alzheimer disease or related syndromes) at the University Hospital of Reims, France.
Participants: Older patients with dementia syndrome (Alzheimer disease or related syndromes).
Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia or alzheimer dementia | – | –All patients presenting with dementia syndrome and whose admission was unplanned between May 2010 and November 2011 were consecutively included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with dementia syndrome and whose admission was unplanned between May 2010 and November 2011 were consecutively included in the study.
Key inclusion criteria (2 listed)
- diagnosis of dementia syndrome
- unplanned hospitalisation between may 2010 and november 2011
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors for the occurrence of adverse drug reactions
Time frame: Month 18
Factors (as comprehensive geriatric assessment : instrumental activities of daily living scale, Katz's activities of daily living scale, mini nutritional assessment short-form, mini mental state examination) associated with adverse drug reaction
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 9 Aug 2018.
- Background: PubMed 27742527Kanagaratnam L, Drame M, Novella JL, Trenque T, Joachim C, Nazeyrollas P, Jolly D, Mahmoudi R. Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit. Am J Geriatr Psychiatry. 2017 Mar;25(3):290-296. doi: 10.1016/j.jagp.2016.07.002. Epub 2016 Sep 1.
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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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 9 Aug 2018. 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?
Risk factors for the occurrence of adverse drug reactions (time frame: Month 18). 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 NCT03623542, which also lists 1 linked publication.
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 9 Aug 2018.