FrailtyFRAIL-DOMNCT05163457
Prevalence of Frailty Among People Aged 75 and Over Living at Home
An observational study of Frailty, run by Université de Reims Champagne-Ardenne at 1 site in France.
Trial summary
The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Data collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2022to 22 Feb 2022
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients aged of 75 and more living at home
Who may be able to join
- male or female
- aged of 75 and more
- living at home
- agreeing to participate in the study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Maison de Santé Pluridisciplinaire de Bar sur Seine
Bar-sur-Seine, Grand Est, 10110
About this study
The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. In fact, many scales to measure frailty have emerged without gold standard.
The SEGAm showed its usefulness in aged patients living at home.
Read the detailed description
The aim of the study is to describe prevalence of frailty in patients aged of 75 and more living at home.
- Conditions
- Frailty
- Being tested
- Data collection
- Keywords
- Frailty - SEGAm - living at home
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
frailty evaluation
| Study group | Role | What they receive |
|---|---|---|
| aged of 75 and more living at home | aged of 75 and more living at home" group: patients aged of 75 and more living at home Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Frailty evaluated using SEGA modified scale (SEGAm). SEGAm includes 13 items (coded from 0 to 2) to obtain a global score out of 26 points. Patients with a score less than or equal to 8 are considered not fragile. Patients with a score between 8 and 11 are considered fragile. Patients with a score greater than or equal to 11 are considered very fragile.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start6 Jan 2022
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163457
- Sponsor's protocol ID
- 2021-012-FRAIL-DOM
- Acronym
- FRAIL-DOM
- Status last verified
- Mar 2022
- First submitted
- 6 Dec 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Frailty Among People Aged 75 and Over Living at Home
- ClinicalTrials.gov ID
- NCT05163457
- Acronym / sponsor ID
- FRAIL-DOM / 2021-012-FRAIL-DOM
- Conditions
- Frailty
- Keywords
- Frailty - SEGAm - living at home
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 20 Dec 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.
The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. In fact, many scales to measure frailty have emerged without gold standard.
The SEGAm showed its usefulness in aged patients living at home.
Detailed description
The aim of the study is to describe prevalence of frailty in patients aged of 75 and more living at home.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aged of 75 and more living at home | – | Other: Data collectionaged of 75 and more living at home" group: patients aged of 75 and more living at home |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients aged of 75 and more living at home
Key inclusion criteria (4 listed)
- male or female
- aged of 75 and more
- living at home
- agreeing to participate in the study
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Data collectionfrailty evaluation | Other | aged of 75 and more living at home |
Primary outcome
Frailty
Time frame: Day 0
Frailty evaluated using SEGA modified scale (SEGAm). SEGAm includes 13 items (coded from 0 to 2) to obtain a global score out of 26 points. Patients with a score less than or equal to 8 are considered not fragile. Patients with a score between 8 and 11 are considered fragile. Patients with a score greater than or equal to 11 are considered very fragile.
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 10 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Université de Reims Champagne-Ardenne at 1 site 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 1 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (time frame: Day 0). 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 10 Mar 2022.