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CompletedNCT02087982ReperAgeUpdated Dec 20, 2016

Development of General Practitioners Screening Tool of Frail Older Old Community

An observational study in Aged (80 or More) and Healthy, sponsored by Gerontopôle des Pays de la Loire. Completed at 1 site in France. Open to participants aged 80 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-20.

Sponsored by Gerontopôle des Pays de la Loire · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
840
Ages
80 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Aged (80 or More)
  • Healthy
03

In context

Lead sponsor

This is the only study on the registry with Gerontopôle des Pays de la Loire as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

adults aged 80 and over

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
840 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Hospitalization between inclusion and follow up to 6 months

Secondary outcomes

  1. Number of subjects' institutionnalized

    Time frame: Institutionnalization between inclusion and follow up at 3 or 6 months

  2. Number of dead subjects

    Time frame: Death between inclusion and follow up at 3 or 6 months

Other outcomes

  1. Number of non planned consultations by subjects

    Time frame: Number of non planned consultations between inclusion and follow up at 3 or 6 months

07

Study locations

1 site
  • Nord Pas de Calais
    Leers, 59115, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02087982
Lead sponsor
Gerontopôle des Pays de la Loire
Collaborators
University Hospital, Angers
Responsible party
Sponsor
First posted
Mar 14, 2014
Start date
Jan 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 20, 2016

Study contacts

Gilles Berrut, PhD
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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