Aged (80 or More)ReperAgeNCT02087982
Development of General Practitioners Screening Tool of Frail Older Old Community
An observational study of Aged (80 or More) and Healthy, run by Gerontopôle des Pays de la Loire at 1 site in France.
Trial summary
The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological, and functional capabilities of an elderly person, in order to develop a coordinated and integrated plan for treatment. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged (80 or More), Healthy
- How many people
- 840 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Dec 2016
- 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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: adults aged 80 and over
Who may be able to join
- Eligible patients are those who meet the following inclusion criteria:
- the patient is aged 80 or more,
- the patient comes to a normal medical consultation without any acute health problem,
- the patient lives at home,
- the patient is able to respond to questions he is asked,
- the patient has given his agreement to answer questions during the initial consultation, to answer further questions by telephone after 3 months and to return in 6 months for a further consultation,
- the life expectancy of the patient as estimated by the primary care practitioner is greater than 6 months.
- the patient has french nationality and is a member of a national Social Security scheme.
Who cannot join
- Patients are ineligible if :
- one inclusion criteria is not met,
- if a close relation of the patient does not agree the patient to be part of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of General Practitioners Screening Tool of Frail Older Old Community-dwellers: a Cohort Population-based Study
The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological, and functional capabilities of an elderly person, in order to develop a coordinated and integrated plan for treatment. It represents the first stage of the most appropriate care for elderly people who are frail or who cannot perform at least three daily tasks unaided.
It has been shown that the integration of CGA in the decision-making and care management at hospital improves inpatient's health and functional status, and reduces mortality rate and healthcare expenditures. The effects of CGA in daily practice of general practitioners remain unknown.
Read more
Implementation of a systematic CGA for every older old community-dwellers performed by a general practitioner remains yet difficult because of number of issues. First, although the number of older old community-dwellers keeps increasing, the number of health care professional with geriatric skills does not. Second, CGA is a complex and time-consuming process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone the care of all frail older old community-dwellers due to their limited number. An implication of non-geriatricians in CGA is therefore required.
Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best compromise could be the use of a two-step approach. The first step is the identification by non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening tool, and the second step is a CGA by geriatricians with a diagnosis purpose.
None of existing tools used for screening is adapted to the population of elderly people who visit general practitioners.Thus, healthcare professionals working in ED need a simple, standardized and brief geriatric assessment (BGA) to identify as soon as possible frail older old community-dwellers requiring specialized geriatric care.
The investigators hypothesized that a BGA older old community-dwellers carried out by a general practitioner could predict the adverse health events (i.e. hospitalization, institutionalisation, medical consultations and death) occurring during a 6-months follow-up period before the evaluation.
- Conditions
- Aged (80 or More), Healthy
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 |
|---|---|---|
| Seniors | The study will be based on a 6-months assessment period, with two consecutive monitoring visits on enrollment. Patient follow-up after 3 months will be conducted by telephone and monitoring after 6 months will be carried out as part of a routine consultation. Each subject will have a BGA (Brief Geriatric assesment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of non planned hospitalization by subjects
The BGA test will include the following criteria:
- age,
- sex,
- the ability to give the current month and year,
- the occurrence of falls during the last 6 months,
- the presence of more than 4 classes of prescribed drugs,
- the presence of professional or other assistance help at home.
All following adverse health events occurring during a 6-months period of follow-up :
- Hospitalization,
- Institutionalisation,
- Medical consultations,
- Death.
Measured: Hospitalization between inclusion and follow up to 6 months
Secondary outcomes (2)
Number of subjects' institutionnalized
Measured: Institutionnalization between inclusion and follow up at 3 or 6 months
Number of dead subjects
Measured: Death between inclusion and follow up at 3 or 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged (80 or More)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerontopôle des Pays de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers
- Responsible party
- Sponsor
- Investigators
- Gilles Berrut, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087982
- Sponsor's protocol ID
- Reperage - 23
- Acronym
- ReperAge
- Status last verified
- Dec 2016
- First submitted
- 28 Oct 2013
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of General Practitioners Screening Tool of Frail Older Old Community-dwellers: a Cohort Population-based Study
- ClinicalTrials.gov ID
- NCT02087982
- Acronym / sponsor ID
- ReperAge / Reperage - 23
- Conditions
- Aged (80 or More), Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Gerontopôle des Pays de la LoireUniversity, hospital or other
- Collaborators
- University Hospital, Angers
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Mar 2014 (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 comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological, and functional capabilities of an elderly person, in order to develop a coordinated and integrated plan for treatment. It represents the first stage of the most appropriate care for elderly people who are frail or who cannot perform at least three daily tasks unaided.
It has been shown that the integration of CGA in the decision-making and care management at hospital improves inpatient's health and functional status, and reduces mortality rate and healthcare expenditures. The effects of CGA in daily practice of general practitioners remain unknown.
Implementation of a systematic CGA for every older old community-dwellers performed by a general practitioner remains yet difficult because of number of issues. First, although the number of older old community-dwellers keeps increasing, the number of health care professional with geriatric skills does not. Second, CGA is a complex and time-consuming process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone the care of all frail older old community-dwellers due to their limited number. An implication of non-geriatricians in CGA is therefore required.
Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best compromise could be the use of a two-step approach. The first step is the identification by non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening tool, and the second step is a CGA by geriatricians with a diagnosis purpose.
None of existing tools used for screening is adapted to the population of elderly people who visit general practitioners.Thus, healthcare professionals working in ED need a simple, standardized and brief geriatric assessment (BGA) to identify as soon as possible frail older old community-dwellers requiring specialized geriatric care.
The investigators hypothesized that a BGA older old community-dwellers carried out by a general practitioner could predict the adverse health events (i.e. hospitalization, institutionalisation, medical consultations and death) occurring during a 6-months follow-up period before the evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seniors | – | –The study will be based on a 6-months assessment period, with two consecutive monitoring visits on enrollment. Patient follow-up after 3 months will be conducted by telephone and monitoring after 6 months will be carried out as part of a routine consultation. Each subject will have a BGA (Brief Geriatric assesment). |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- adults aged 80 and over
Key inclusion criteria (8 listed)
- the patient is aged 80 or more,
- the patient comes to a normal medical consultation without any acute health problem,
- the patient lives at home,
- the patient is able to respond to questions he is asked,
- the patient has given his agreement to answer questions during the initial consultation, to answer further questions by telephone after 3 months and to return in 6 months for a further consultation,
Key exclusion criteria (3 listed)
- one inclusion criteria is not met,
- if a close relation of the patient does not agree the patient to be part of the study.
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
Number of non planned hospitalization by subjects
Time frame: Hospitalization between inclusion and follow up to 6 months
The BGA test will include the following criteria: * age, * sex, * the ability to give the current month and year, * the occurrence of falls during the last 6 months, * the presence of more than 4 classes of prescribed drugs, * the presence of professional or other assistance help at home. All following adverse health events occurring during a 6-months period of follow-up : * Hospitalization, * Institutionalisation, * Medical consultations, * Death.
2 secondary outcomes
Number of subjects' institutionnalized
Time frame: Institutionnalization between inclusion and follow up at 3 or 6 months
Number of dead subjects
Time frame: Death between inclusion and follow up at 3 or 6 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 20 Dec 2016.
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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.
Gilles Berrut, PhD principal investigator
Nantes University Hospital
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 Aged (80 or More) and Healthy, run by Gerontopôle des Pays de la Loire 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 8 inclusion and 3 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 20 Dec 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?
Number of non planned hospitalization by subjects (time frame: Hospitalization between inclusion and follow up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2016.