AzTrials
AzTrials

Geriatric Assessment5P-ECHELLENCT05090241

Frailty Prevention in Elders From Reunion Island

An observational study of Geriatric Assessment and Frail Elderly Syndrome, run by Universite de La Reunion at 2 sites in Reunion.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty. The study evaluates tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Instrumental measurement of balance and gait
How many people
147 participants
Where
2 sitesReunion
Study dates
1 Nov 2021to 27 Dec 2023
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 65 years and older
  • All sexes
  • Older adult

Study population: Patients over 65 years of age consulting a general practice. Consecutive participant sampling.

Who may be able to join

  • Persons over 65 years of age
  • Retired persons
  • Person affiliated to or benefiting from a social security scheme.
  • Free and informed consent given

Who cannot join

  • Persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons), pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure
  • Difficulty in understanding the French language

Trial locations and contacts

2 sites in 1 country.

Reunion2 sites
  • Cabinet Dr HUCHOT et Dr GENSOUS

    Saint-Joseph, 97480

  • MSPU Care Austral

    Saint-Philippe, La Réunion, 97417

Other trials in Reunion

About this study

Official title: Frailty Prevention in Elders From Reunion Island: Detection of Frailty, Age-related Issues and Risk of Falling Among Community Dwelling Elderly

In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty.

The study evaluates tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.

Read the detailed description

The 5P research program is a 6-years program that started in 2016.

Its objective is to set up tools, supported by the latest scientific advances in "machine learning" to detect, identify and measure frailty in order to give health professionals the means to act early through preventive actions.

The diversity and transversal nature of the research disciplines in this program make it original. This allows it, through common protocols, to explore the concept of frailty and the care pathway of the elderly through different prisms of complementary observations.

This program is deployed in three stages: proof of principle, proof of concept (called 5P-PILOT) and "the Scaling up" (called 5P-ECHELLE). It combines an evaluation of the acceptability of technological detection tools, a measurement of the impact of prevention workshops on the loss of autonomy among independent frail elderly people and an evaluation of tools to help detect frailty.

The ageing of the population poses a real societal challenge. The loss of autonomy, which is the result of multiple individual or environmental factors for the ageing person, has a costly impact in terms of recourse to care and on the people around them. It is therefore urgent to act on the levers of frailty by acting as early as possible to prevent its irreversibility.

The "5P ECHELLE" project aims to develop a semi-automatic and non-medical method for detecting weak signals of frailty in older people, by combining standardized clinical indicators for assessing their state of robustness with large-scale intelligent detection devices that allow for longitudinal monitoring, while integrating the necessary participatory dimension of the subject.

Being tested
Instrumental measurement of balance and gait

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Instrumental measurement of balance and gaitDiagnostic test

    The balance measurement was performed on a force platform. The walk test was carried out using sensors to analyze and retrieve data from the participant's walk (gait speed, step length, duration of the double support phase).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of falls

    Collection of falls by diary with monthly telephone survey for 6 months. A fall is defined as an event in which an individual inadvertently falls to the ground or any other surface below the level of origin.

    Measured: Change from baseline in the number of falls to 6 months.

Secondary outcomes (18)
  1. Change in balance performance

    The balance measurement was performed on a force platform. The senior citizen was positioned barefoot on the strength platform. The measurement was performed for 30 seconds with eyes open, then with eyes closed for 30 seconds. Postural control acquisition data, and more specifically the displacement of the center of pressure was measured in both the medio-lateral and antero-posterior dimensions. Small variations are better.

    Measured: Change from baseline in balance performance to 6 months.

  2. Change in gait performance

    The gait test was carried out using sensors to analyze and retrieve data from the participant's walk (gait speed, step length, duration of the double support phase). Four X-sens® Motion Tracker Wireless sensors were positioned on the clothes with headbands as follows: one at forehead level on the median sagittal line, the second opposite the L4 vertebra and the last two on the dorsal surface of the right and left feet at mid-foot level. Then, the patient walked 10 meters in a straight line, made a half turn and walked 10 meters again. Higher gait speed is better.

    Measured: Change from baseline in balance and gait performance to 6 months.

  3. Frailty according to "Fried et al" criteria

    The Fried criteria are a list of 5 criteria to define the elderly frailty. Weight loss: "In the last year, have you lost more than 3 kilograms unintentionally?" If yes, then frail for weight loss criterion.

    Exhaustion: the following two statements are read. (a) I felt that everything I did was an effort; (b) I could not get going. The question is asked "How often in the last week did you feel this way?" 0 = rarely or none of the time (< 1 day), 1 = some or a little of the time (1-2 days), 2 = a moderate amount of the time (3-4 days), or 3 = most of the time. Subjects answering "2" or "3" to either of these questions are categorized as frail by the exhaustion criterion.

    Walk Time: Cutoff for time to walk 4 meters criterion for frailty, >= 7 seconds Grip Strength: cutoff for grip strength (Kilogram) criterion for frailty < 30 for men, <17 for women. A person is frail if 3 out of 5 criteria are found, pre-frail if 1 or 2 are found, or robust if no criterion are found.

    Measured: Assessed at baseline

  4. The Short Physical Performance Battery (SPPB)

    The Short Physical Performance Battery is the sum of the scores on three criteria: the balance test, the walking speed test and the chair lift test. This test is used to evaluate the physical performance of an individual. Total points 0 - 12. Higher scores mean a better outcome.

    Measured: Assessed at baseline

  5. Falls Risk for Older People in the Community (FROP-COM)

    The FROP-COM consists of 13 risk factors being rated, most on a graded 0-3 scale. Higher scores mean a worse outcome.

    Measured: Assessed at baseline

  6. Who's Integrated care for older people (ICOPE) screening tool

    Who's "ICOPE" screening tool consists of 5 tests: Cognitive decline: Remember three words: flower, door, rice (for example) and recalls, Limited mobility: Chair rise test: Rise from chair five times without using arms. Did the person complete five chair rises within 14 seconds? Weight loss: Have you unintentionally lost more than 3 kg over the last three months? Visual impairment: Do you have any problems with your eyes: difficulties in seeing far, reading, eye diseases or currently under medical treatment (e.g. diabetes, high blood pressure)? Hearing lost: Hears whispers (whisper test). Depressive symptoms: Over the past two weeks, have you been bothered by

    • feeling down, depressed or hopeless?
    • little interest or pleasure in doing things? Score from 0 to 5, Higher scores mean a worse outcome.

    Measured: Assessed at baseline

  7. The "Codex" score

    The "Codex" test assesses the cognitive functions of elderly subjects in less than 3 minutes. It test involves memory, executive functions, attention, and visual-spatial praxis.

    It includes:

    • a memory task: memorize 3 words, then recall them,
    • the drawing of a watch face: this is the simplified clock test,
    • and according to the results of these first 2 tasks: 5 questions of orientation in space.

    If the 2 tasks (Clock and 3 words recall) are normal, the test is over: CODEX normal. If the 2 tasks are abnormal, the test is finished : CODEX abnormal!

    Measured: Assessed at baseline

  8. Height in meters

    Height in meters using a height gauge. Weight and height will be combined to report Body Mass Index (BMI) in kg/m^2

    Measured: Assessed at baseline

  9. Weight in kilograms

    The weight in kilos using a scale. Weight and height will be combined to report Body Mass Index (BMI) in kg/m^2.

    Measured: Assessed at baseline

  10. The Evaluation of precariousness and health inequalities in the examination centers" (EPICES) score

    EPICES score (Evaluation of precariousness and health inequalities in the examination centers) is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness. multidimensional nature of precariousness. The main interest of the EPICES score is to apprehend populations which, while not covered by traditional administrative indicators of precariousness, present the same health risks. The answer to each question is The sum of the 11 answers gives the EPICES score. The score is The score is continuous and varies from 0 (no precariousness) to 100 (maximum precariousness). The threshold of 30 is considered the precariousness threshold according to "EPICES".

    Measured: Assessed at baseline

  11. Standardised Assessment of Personality - Abbreviated Scale (SAPAS) Moran

    A simple 8-question personality disorder screening test. A total score of 3/8 or more indicates personality disorder is likely.

    Measured: Assessed at baseline

  12. The frailty of groups with equal resources (FRAGIRE) grid.

    The FRAGIRE grid is an assessment tool that aims to detect, among non-dependent retirees. It consists of 17 multiple-choice questions on physiological feelings, state of health, depression, pleasure, suicidal thoughts, social and cultural environment, taste, appetite, oral health, motor skills and 1 question for the evaluator on the person's state of health. Higher scores mean a worse outcome.

    Measured: Assessed at baseline

  13. Medical Outcomes Study 36-item Short-Form (SF-36)

    Quality of life assessed by Short-Form 36 questionnaire. Higher scores mean a better outcome.

    Measured: Assessed at baseline

  14. Hospital Anxiety and Depression Scale (HADS)

    The Hospital Anxiety and Depression Scale scale is an instrument for screening for anxiety and depressive disorders. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21). Higher scores mean a worse outcome.

    Measured: Assessed at baseline

  15. Hearing Handicap Inventory for the Elderly Screening (HHIE-S)

    The Hearing Handicap Inventory for the Elderly Screening is a self-assessment tool containing 10 questions aimed to assess the impact of hearing loss in the emotional and social-situational adjustments of elderly patients who are not institutionalized. Higher scores mean a worse outcome.

    Measured: Assessed at baseline

  16. Mini Mental State Examination (MMSE)

    The Mini-Mental State Examination is a cognitive assessment instrument developed for rapid screening of cognitive deficits in 30 questions. Higher scores mean a better outcome.

    Measured: Assessed at baseline

  17. World Health Organization (WHO) visual acuity measurement

    Measurement of visual acuity using the Raskin E scale. Distance visual acuity measured at 3 meters and near visual acuity at 40 centimeters. Score expressed in 1/(arc min). Higher scores mean a better outcome.

    Measured: Assessed at baseline

  18. The Mini Nutritional Assessment (MNA)

    The MNA consists of two parts with 18 items and a score out of 30. The sum of the MNA score distinguishes between elderly patients with: 1) adequate nutritional status, MNA ≥ 24; 2) protein-calorie malnutrition, MNA < 17; 3) at risk of malnutrition, MNA between 17 and 23.5. Higher scores mean a better outcome.

    Measured: Assessed at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start1 Nov 2021
  3. Primary completion27 Dec 2023
  4. Study completion27 Dec 2023

Resources

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
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090241
Sponsor's protocol ID
202005974
Acronym
5P-ECHELLE
Status last verified
May 2024
First submitted
20 Sep 2021
Last updated
13 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Legrand F, Eychene JM, Audiffren J, Klein A, Labourdette C, Nicolai A, Sandron F, Vidal PP. The 5P program, personalized and participatory primary prevention pathway: Rational and design of a clinical trial in general practice. Contemp Clin Trials Commun. 2021 Jun 3;22:100786. doi: 10.1016/j.conctc.2021.100786. eCollection 2021 Jun.

    PubMed 34159279
  • Legrand F, Eychene JM, Audiffren J, Klein A, Labourdette C, Nicolai A, Sandron F, Vidal PP. Description of Participants in the "Atout Age Mobility" Prevention Workshops at the University Hospital Center of La Reunion: A Prospective Study. J Nutr Health Aging. 2021;25(5):628-636. doi: 10.1007/s12603-021-1604-8.

    PubMed 33949630

Questions about this trial

What is this clinical trial studying?

An observational study of Geriatric Assessment and Frail Elderly Syndrome, run by Universite de La Reunion at 2 sites in Reunion.

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 4 inclusion and 2 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Reunion. 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?

Change in the number of falls (time frame: Change from baseline in the number of falls to 6 months.). 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 NCT05090241, which also lists 2 linked publications.

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 13 May 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in