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.
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
- Conditions the study is for
- Geriatric Assessment, Frail Elderly Syndrome, Prevention
- 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
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.
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)
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted22 Oct 2021
- Study start1 Nov 2021
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Geriatric AssessmentStudies 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite de La Reunion
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, Centre Hospitalier Universitaire de la Réunion, General Social Security Fund
- Responsible party
- Principal investigator, Florian Legrand, Universite de La Reunion
- Investigators
- Jean-Marc EYCHENE, MD, Study director, Centre Hospitalier Universitaire de La ReunionPierre-Paul VIDAL, MD, Study director, Laboratoire BorelliFrederic SANDRON, Study director, Institut de Recherche pour le Développement (IRD)Jean-Marc FRANCO, MD, Study director, Universite de La Reunion
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 34159279Legrand 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Prevention in Elders From Reunion Island: Detection of Frailty, Age-related Issues and Risk of Falling Among Community Dwelling Elderly
- ClinicalTrials.gov ID
- NCT05090241
- Acronym / sponsor ID
- 5P-ECHELLE / 202005974
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Universite de La ReunionUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, Centre Hospitalier Universitaire de la Réunion, General Social Security Fund
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients over 65 years of age consulting a general practice. Consecutive participant sampling.
Key inclusion criteria (4 listed)
- Persons over 65 years of age
- Retired persons
- Person affiliated to or benefiting from a social security scheme.
- Free and informed consent given
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Instrumental measurement of balance and gaitThe 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). | Diagnostic test | – |
Primary outcome
Change in the number of falls
Time frame: Change from baseline in the number of falls to 6 months.
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.
18 secondary outcomes
Change in balance performance
Time frame: Change from baseline in balance performance to 6 months.
Change in gait performance
Time frame: Change from baseline in balance and gait performance to 6 months.
Frailty according to "Fried et al" criteria
Time frame: Assessed at baseline
The Short Physical Performance Battery (SPPB)
Time frame: Assessed at baseline
Falls Risk for Older People in the Community (FROP-COM)
Time frame: Assessed at baseline
Who's Integrated care for older people (ICOPE) screening tool
Time frame: Assessed at baseline
The "Codex" score
Time frame: Assessed at baseline
Height in meters
Time frame: Assessed at baseline
Weight in kilograms
Time frame: Assessed at baseline
The Evaluation of precariousness and health inequalities in the examination centers" (EPICES) score
Time frame: Assessed at baseline
Standardised Assessment of Personality - Abbreviated Scale (SAPAS) Moran
Time frame: Assessed at baseline
The frailty of groups with equal resources (FRAGIRE) grid.
Time frame: Assessed at baseline
Medical Outcomes Study 36-item Short-Form (SF-36)
Time frame: Assessed at baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Assessed at baseline
Hearing Handicap Inventory for the Elderly Screening (HHIE-S)
Time frame: Assessed at baseline
Mini Mental State Examination (MMSE)
Time frame: Assessed at baseline
World Health Organization (WHO) visual acuity measurement
Time frame: Assessed at baseline
The Mini Nutritional Assessment (MNA)
Time frame: Assessed at baseline
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 13 May 2024.
- Background: PubMed 34159279Legrand 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.
- Background: PubMed 33949630Legrand 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.
- Individual participant dataSharing planned: No
Related trials for Geriatric Assessment
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
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.
Jean-Marc EYCHENE, MD study director
Centre Hospitalier Universitaire de La Reunion
Pierre-Paul VIDAL, MD study director
Laboratoire Borelli
Frederic SANDRON study director
Institut de Recherche pour le Développement (IRD)
2 sites in 1 country: see every site and its status.
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.