FrailtyNCT04085432
Validation of a Frailty Self Assessment Tool
An observational study of Frailty, run by International Longevity Centre France at 2 sites in France.
Trial summary
The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Self administered questionnaire and Clinical evaluation
- How many people
- 5,134 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Oct 2019to 19 Aug 2020
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Retirees aged 70 and over, living at home
Who may be able to join
- Retirees from the National Old-Age Insurance Fund
- Aged 70 or older,
- Living at home
- Representatives of the general population
Who cannot join
- Institutionalized retirees
- Retirees receiving the Personalised Allowance for Autonomy
- Retirees who enrolled in previous studies
Trial locations and contacts
2 sites in 1 country.
France2 sites
Broca Hospital Geriatric Department
Paris, 75013
GERONTOPOLE of the Toulouse University Hospital
Toulouse, 31300
About this study
Official title: Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over
The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Frailty can be reversed through appropriate interventions particularly when they are implemented early. Therefore, early detection of frailty is a major objective. The goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. The results of the self assessment will be compared to the Fried criteria collected by a clinical examination conducted by a healthcare Professional blinded to the self assessment results.
Read the detailed description
Five thousands (5000) retirees aged 70 and over will be randomly selected from National Retirement Pension Institute (CNAV) retirees (2500 living in Paris and 2500 living in Toulouse). They will receive a letter from the CNAV explaining the study approach and a separate self-assessment frailty questionnaire to be filled in by the retirees at home and sent back in a pre-paid envelope to International Longevity Centre France (ILC-France).
Retirees who have accepted the home assessment are examined by a healthcare professional, blinded to the results of self-administered questionnaire, using the Fried's frailty criteria in order to confirm or infirm the diagnosis of frailty.
The General practitioner will be informed of the investigation results in order to set up a personalized prevention plan.
ILC-France will anonymize both the self-administered questionnaires and the Fried assessments and send them to the Mixed Research Unit (UMR) 1027 in Toulouse.
Comparison of the Fried assessment results with those of the self-questionnaire will confirm the metrological characteristics (false negative, false positive, sensitivity, specificity, predictive value) of the questionnaire.
Secondary analyses will be conducted to compare the prevalence of frailty by age and gender.
The statistical analysis is carried out by the UMR 1027 of Toulouse.
- Conditions
- Frailty
- Being tested
- Self administered questionnaire and Clinical evaluation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self administered questionnaire and Clinical evaluationOther
Self administered questionnaire and clinical evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty and pre-frailty diagnosis rate
Frailty and pre-frailty diagnosis rate are detected by self administered questionnaire and confirmed by the Fried's frailty phenotype assessment
Measured: October 2019 to August 2020
Secondary outcomes (1)
Prevalence of frailty by age and gender
Prevalence of frailty by age and gender
Measured: October 2019 to August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start3 Oct 2019
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 5,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Longevity Centre France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise FORETTE, MD, Principal investigator, ILC France and Universite Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085432
- Sponsor's protocol ID
- CNAV- ILC France 2
- Other IDs
- 2018-A03324-51
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study for a Frailty Self Assessment Tool in Retirees Aged 70 and Over
- ClinicalTrials.gov ID
- NCT04085432
- Acronym / sponsor ID
- CNAV- ILC France 2
- Conditions
- Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,134 participants (actual)
- Lead sponsor
- International Longevity Centre FranceUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 11 Sep 2019 (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.
The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Frailty can be reversed through appropriate interventions particularly when they are implemented early. Therefore, early detection of frailty is a major objective. The goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. The results of the self assessment will be compared to the Fried criteria collected by a clinical examination conducted by a healthcare Professional blinded to the self assessment results.
Detailed description
Five thousands (5000) retirees aged 70 and over will be randomly selected from National Retirement Pension Institute (CNAV) retirees (2500 living in Paris and 2500 living in Toulouse). They will receive a letter from the CNAV explaining the study approach and a separate self-assessment frailty questionnaire to be filled in by the retirees at home and sent back in a pre-paid envelope to International Longevity Centre France (ILC-France).
Retirees who have accepted the home assessment are examined by a healthcare professional, blinded to the results of self-administered questionnaire, using the Fried's frailty criteria in order to confirm or infirm the diagnosis of frailty.
The General practitioner will be informed of the investigation results in order to set up a personalized prevention plan.
ILC-France will anonymize both the self-administered questionnaires and the Fried assessments and send them to the Mixed Research Unit (UMR) 1027 in Toulouse.
Comparison of the Fried assessment results with those of the self-questionnaire will confirm the metrological characteristics (false negative, false positive, sensitivity, specificity, predictive value) of the questionnaire.
Secondary analyses will be conducted to compare the prevalence of frailty by age and gender.
The statistical analysis is carried out by the UMR 1027 of Toulouse.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Retirees aged 70 and over, living at home
Key inclusion criteria (4 listed)
- Retirees from the National Old-Age Insurance Fund
- Aged 70 or older,
- Living at home
- Representatives of the general population
Key exclusion criteria (3 listed)
- Institutionalized retirees
- Retirees receiving the Personalised Allowance for Autonomy
- Retirees who enrolled in previous studies
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 |
|---|---|---|
| Self administered questionnaire and Clinical evaluationSelf administered questionnaire and clinical evaluation | Other | – |
Primary outcome
Frailty and pre-frailty diagnosis rate
Time frame: October 2019 to August 2020
Frailty and pre-frailty diagnosis rate are detected by self administered questionnaire and confirmed by the Fried's frailty phenotype assessment
1 secondary outcome
Prevalence of frailty by age and gender
Time frame: October 2019 to August 2020
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 18 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Françoise FORETTE, MD principal investigator
ILC France and Universite Paris Descartes
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 Frailty, run by International Longevity Centre France at 2 sites 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 4 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 18 Sep 2020. 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 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?
Frailty and pre-frailty diagnosis rate (time frame: October 2019 to August 2020). 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 18 Sep 2020.