Healthy VolunteersSEGAmNCT02852200
Screening for Frailty at Home
An observational study of Healthy Volunteers, run by CHU de Reims at 1 site in France.
Trial summary
"Many tools to evaluate frailty have been developed. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SEGAm
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Mar 2013
- 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
- Healthy volunteers accepted
- Older adult
Study population: Elderly community-dwelling people aged 65 years or over
Who may be able to join
- Age: 65 years or more
- Living at home
- Able to read and understand French
- With a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Frailty in Elderly Subjects Living at Home : Validation of the Modified Short Emergency Geriatric Assessment (SEGAm) Instrument
"Many tools to evaluate frailty have been developed. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home.
It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument. "
Read the detailed description
Many tools to evaluate frailty have been developed. However, most are designed for use in the hospital setting, with the resultant drawback that they are not suitable for routine use in the community setting. A few tools have been developed for use in community-dwelling subjects, such as the Cardiovascular Health Study (CHS) developed by Fried from a cohort of subjects aged 65 and older; the Study of Osteoporotic Fractures (SOF); or the SHARE frailty instrument, developed in a cohort of the same name comprising subjects aged 50 years and older living at home. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home. It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument.
- Conditions
- Healthy Volunteers
- Being tested
- SEGAm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEGAmOther
| Study group | Role | What they receive |
|---|---|---|
| SEGAm | Elderly community-dwelling people Receives: Other: SEGAm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The psychometric properties of SEGAm measured by questionnaire
The SEGAm to be validated comprises Sheet A, which evaluates frailty per se on a 13-item scale, with each item graded either 0 (most favourable state), 1, or 2 (least favourable state), thus making it possible to classify subjects into three groups: not very frail (score ≤8), frail (8<score ≤11), and very frail (score> 11). The SEGAm was administered by social workers, ergotherapists, nurses and non-medical personnel trained in administration of the instrument.
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852200
- Sponsor's protocol ID
- PO12146
- Acronym
- SEGAm
- Status last verified
- Oct 2017
- First submitted
- 17 Jun 2016
- Last updated
- 17 Oct 2017
- Results posted
- No
Publications
Oubaya N, Mahmoudi R, Jolly D, Zulfiqar AA, Quignard E, Cunin C, Nazeyrollas P, Novella JL, Drame M. Screening for frailty in elderly subjects living at home: validation of the Modified Short Emergency Geriatric Assessment (SEGAm) instrument. J Nutr Health Aging. 2014;18(8):757-64. doi: 10.1007/s12603-014-0541-1.
PubMed 25286456
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Frailty in Elderly Subjects Living at Home : Validation of the Modified Short Emergency Geriatric Assessment (SEGAm) Instrument
- ClinicalTrials.gov ID
- NCT02852200
- Acronym / sponsor ID
- SEGAm / PO12146
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 167 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Aug 2016 (estimated)
- 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.
"Many tools to evaluate frailty have been developed. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home.
It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument. "
Detailed description
Many tools to evaluate frailty have been developed. However, most are designed for use in the hospital setting, with the resultant drawback that they are not suitable for routine use in the community setting. A few tools have been developed for use in community-dwelling subjects, such as the Cardiovascular Health Study (CHS) developed by Fried from a cohort of subjects aged 65 and older; the Study of Osteoporotic Fractures (SOF); or the SHARE frailty instrument, developed in a cohort of the same name comprising subjects aged 50 years and older living at home. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home. It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEGAm | – | Other: SEGAmElderly community-dwelling people |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly community-dwelling people aged 65 years or over
Key inclusion criteria (4 listed)
- Age: 65 years or more
- Living at home
- Able to read and understand French
- With a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SEGAm | Other | SEGAm |
Primary outcome
The psychometric properties of SEGAm measured by questionnaire
Time frame: 12 months after inclusion
The SEGAm to be validated comprises Sheet A, which evaluates frailty per se on a 13-item scale, with each item graded either 0 (most favourable state), 1, or 2 (least favourable state), thus making it possible to classify subjects into three groups: not very frail (score ≤8), frail (8<score ≤11), and very frail (score> 11). The SEGAm was administered by social workers, ergotherapists, nurses and non-medical personnel trained in administration of the instrument.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Background: PubMed 25286456Oubaya N, Mahmoudi R, Jolly D, Zulfiqar AA, Quignard E, Cunin C, Nazeyrollas P, Novella JL, Drame M. Screening for frailty in elderly subjects living at home: validation of the Modified Short Emergency Geriatric Assessment (SEGAm) instrument. J Nutr Health Aging. 2014;18(8):757-64. doi: 10.1007/s12603-014-0541-1.
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Screening Protocol
Pain
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 Healthy Volunteers, run by CHU de Reims 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: stopped early, as of the sponsor's last update on 17 Oct 2017. 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 was stopped early. Results are not available in the source record.
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?
The psychometric properties of SEGAm measured by questionnaire (time frame: 12 months after inclusion). 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 NCT02852200, which also lists 1 linked publication.
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 17 Oct 2017.