Cognitive ImpairmentNCT01816087
Performances of a Brief Assessment Tool for the Early Diagnosis of Geriatric Syndromes by Primary Care Physicians
A study testing brief geriatric assessment in people with Cognitive Impairment and Mood Disorders, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The AGE (Active Geriatric Evaluation) aims to develop a brief assessment tool adapted to the primary care setting. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Mood Disorders, Urinary Incontinence
- What is being tested?
- brief geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Nov 2014
- Phase
- Interventional
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age > 70 years
- follow-up by general practitioner
- good understanding of french or presence of a translater
- No previous or on-going geriatric consultation
- Patient able to provide consent or a relative is present that can provide a consent instead
Who cannot join
- Age < 70 years
- No follow-up by general practitioner
- Unable to understand French or absence of a translater
- On-going geriatric follow-up
- Patient unable to provide consent or a relative is absent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Departement of Ambulatory Care and Community Medicine
Lausanne, Canton of Vaud, 1011
About this study
Official title: Study AGE - Part 2 (Active Geriatric Evaluation for General Practitioner), Performances of a Brief Assessment Tool for the Early Diagnosis of Geriatric Syndromes by Primary Care Physicians
The AGE (Active Geriatric Evaluation) aims to develop a brief assessment tool adapted to the primary care setting.
Read the detailed description
The AGE (Active Geriatric Evaluation) program is a collaborative project between a primary care institution and a specialised geriatric unit that aims to develop a brief assessment tool (BAT) adapted to the primary care setting. The objective of this study is to assess the performances of the BAT to identify major geriatric syndromes: cognitive impairment; mood disorder; functional impairment; urinary incontinence; malnutrition; gait and balance impairment; osteoporosis; hearing impairment; visual impairment.
In order to achieve our objective, we plan to recruit 155 patients > 70 years old in primary care settings for which primary care physicians will perform the BAT (composed of specific questions and clinical exams). At the end of the consultation, the primary care physician will fill a questionnaire where the absence/presence of syndromes will be recorded (according to the findings of the BAT). Each patient will be then seen a second time by expert geriatricians that will perform a full geriatric evaluation (90 minutes). This will allow to calculate the performances of the intervention (BAT) in terms of sensibility /specificity,...
- Conditions
- Cognitive Impairment, Mood Disorders, Urinary Incontinence, Malnutrition, Osteoporosis, Hearing Impairment
- Being tested
- brief geriatric assessment
- Medical subject headings
- Cognitive Dysfunction, Mood Disorders, Urinary Incontinence, Malnutrition, Osteoporosis, Hearing Loss, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief geriatric assessmentOther
All participants will be screened for geriatric syndromes using the brief assessment tool. Mix a simple questions and simple tests
| Study group | Role | What they receive |
|---|---|---|
| brief assessment tool (BAT) | Experimental | all participants will have a brief assessment tool (BAT) for the identification of geriatric syndromes performed by their general practitioner. Afterwards, all participants will have a full geriatric assessment performed by geriatricians Receives: Other: brief geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility and specificity
performances of the brief assessment tool (BAT) will be measured by calculating sensibility and specificity for each of the geriatric syndromes: cognitive impairment; mood disorder; functional impairment; urinary incontinence; malnutrition; gait and balance impairment; osteoporosis; hearing impairment; visual impairment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2014
- Study completionNov 2014
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 Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Senn, University of Lausanne
- Investigators
- Nicolas Senn, MD PhD, Principal investigator, Department of ambulatory care and community medicine, University of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816087
- Sponsor's protocol ID
- 287/2012
- Status last verified
- Jan 2018
- First submitted
- 20 Feb 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mueller YK, Monod S, Locatelli I, Bula C, Cornuz J, Senn N. Performance of a brief geriatric evaluation compared to a comprehensive geriatric assessment for detection of geriatric syndromes in family medicine: a prospective diagnostic study. BMC Geriatr. 2018 Mar 13;18(1):72. doi: 10.1186/s12877-018-0761-z.
PubMed 29534680
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study AGE - Part 2 (Active Geriatric Evaluation for General Practitioner), Performances of a Brief Assessment Tool for the Early Diagnosis of Geriatric Syndromes by Primary Care Physicians
- ClinicalTrials.gov ID
- NCT01816087
- Acronym / sponsor ID
- 287/2012
- Conditions
- Cognitive Impairment, Mood Disorders, Urinary Incontinence, Malnutrition, Osteoporosis, Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Mar 2013 (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.
The AGE (Active Geriatric Evaluation) aims to develop a brief assessment tool adapted to the primary care setting.
Detailed description
The AGE (Active Geriatric Evaluation) program is a collaborative project between a primary care institution and a specialised geriatric unit that aims to develop a brief assessment tool (BAT) adapted to the primary care setting. The objective of this study is to assess the performances of the BAT to identify major geriatric syndromes: cognitive impairment; mood disorder; functional impairment; urinary incontinence; malnutrition; gait and balance impairment; osteoporosis; hearing impairment; visual impairment.
In order to achieve our objective, we plan to recruit 155 patients > 70 years old in primary care settings for which primary care physicians will perform the BAT (composed of specific questions and clinical exams). At the end of the consultation, the primary care physician will fill a questionnaire where the absence/presence of syndromes will be recorded (according to the findings of the BAT). Each patient will be then seen a second time by expert geriatricians that will perform a full geriatric evaluation (90 minutes). This will allow to calculate the performances of the intervention (BAT) in terms of sensibility /specificity,...
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brief assessment tool (BAT) | Experimental | Other: brief geriatric assessmentall participants will have a brief assessment tool (BAT) for the identification of geriatric syndromes performed by their general practitioner. Afterwards, all participants will have a full geriatric assessment performed by geriatricians |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age > 70 years
- follow-up by general practitioner
- good understanding of french or presence of a translater
- No previous or on-going geriatric consultation
- Patient able to provide consent or a relative is present that can provide a consent instead
Key exclusion criteria (5 listed)
- Age < 70 years
- No follow-up by general practitioner
- Unable to understand French or absence of a translater
- On-going geriatric follow-up
- Patient unable to provide consent or a relative is absent
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 |
|---|---|---|
| brief geriatric assessmentAll participants will be screened for geriatric syndromes using the brief assessment tool. Mix a simple questions and simple tests | Other | brief assessment tool (BAT) |
Primary outcome
Sensibility and specificity
Time frame: one year
performances of the brief assessment tool (BAT) will be measured by calculating sensibility and specificity for each of the geriatric syndromes: cognitive impairment; mood disorder; functional impairment; urinary incontinence; malnutrition; gait and balance impairment; osteoporosis; hearing impairment; visual impairment
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 Jan 2018.
- Derived from this study: PubMed 29534680Mueller YK, Monod S, Locatelli I, Bula C, Cornuz J, Senn N. Performance of a brief geriatric evaluation compared to a comprehensive geriatric assessment for detection of geriatric syndromes in family medicine: a prospective diagnostic study. BMC Geriatr. 2018 Mar 13;18(1):72. doi: 10.1186/s12877-018-0761-z.
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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.
Nicolas Senn, MD PhD principal investigator
Department of ambulatory care and community medicine, University of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief geriatric assessment in people with Cognitive Impairment and Mood Disorders, run by University of Lausanne at 1 site in Switzerland.
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 5 inclusion and 5 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 Jan 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 Switzerland. 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?
Sensibility and specificity (time frame: one year). 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 NCT01816087, 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 Jan 2018.