- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087982
Development of General Practitioners Screening Tool of Frail Older Old Community (ReperAge)
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Leers, France, 59115
- Nord Pas de Calais
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of non planned hospitalization by subjects
Time Frame: Hospitalization between inclusion and follow up to 6 months
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The BGA test will include the following criteria:
All following adverse health events occurring during a 6-months period of follow-up :
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Hospitalization between inclusion and follow up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects' institutionnalized
Time Frame: Institutionnalization between inclusion and follow up at 3 or 6 months
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Institutionnalization between inclusion and follow up at 3 or 6 months
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Number of dead subjects
Time Frame: Death between inclusion and follow up at 3 or 6 months
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Death between inclusion and follow up at 3 or 6 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of non planned consultations by subjects
Time Frame: Number of non planned consultations between inclusion and follow up at 3 or 6 months
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Number of non planned consultations between inclusion and follow up at 3 or 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gilles Berrut, PhD, CHU Nantes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Reperage - 23
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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