Elderly People With Polypathology or DisabilitiesSAFMACohortNCT02871557
Frailty and the Elderly in Martinique
An observational study of Elderly People With Polypathology or Disabilities, run by Société Martiniquaise de Gérontologie et Gériatrie.
Trial summary
This was a prospective multicenter cohort study of elderly people admitted to the acute care for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly People With Polypathology or Disabilities
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2015
- 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: A group of elderly people hospitalised in acute care for elders
Who may be able to join
- Age of 75 years or over
- Admitted to acute care for elders
- Consent to participate
Who cannot join
- Impossibility to perform the tests
- Refusals to participate
About this study
Official title: Frail Elderly Subjects Martinique: Adverse Outcome After Hospitalisation in Geriatric Department
This was a prospective multicenter cohort study of elderly people admitted to the acute care for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%).
Read the detailed description
The SAFMA cohort was an ad hoc study formed into the recruitment of the acute care for elders in the geriatric department of Martinique university Hospitals. The inclusion of subjects ran from January 1st 2012 to June 30th 2012. To be eligible, patients had to be 75 or over and hospitalised for acute condition. Each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was performed by visits and telephone interview till 36 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 6 weeks
Nursing home admission
Measured: 6 weeks
Secondary outcomes (8)
Mortality
Measured: 6 month
Mortality
Measured: 12 month
Mortality
Measured: 24 month
Mortality
Measured: 36 month
Nursing home admission
Measured: 6 month
Nursing home admission
Measured: 12 month
Nursing home admission
Measured: 24 month
Nursing home admission
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionJun 2015
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 Elderly People With Polypathology or DisabilitiesStudies 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Martiniquaise de Gérontologie et Gériatrie
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Reims
- Responsible party
- Principal investigator, Lidvine Godaert, Société Martiniquaise de Gérontologie et Gériatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871557
- Sponsor's protocol ID
- 1958830
- Acronym
- SAFMACohort
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Godard-Sebillotte C, Drame M, Basileu T, Fanon JL, Godaert L. Is self-rated health an independent prognostic factor of six-week mortality in older patients hospitalized for an acute condition? Qual Life Res. 2016 Sep;25(9):2335-40. doi: 10.1007/s11136-016-1252-3. Epub 2016 Feb 26.
PubMed 26919847
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frail Elderly Subjects Martinique: Adverse Outcome After Hospitalisation in Geriatric Department
- ClinicalTrials.gov ID
- NCT02871557
- Acronym / sponsor ID
- SAFMACohort / 1958830
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Société Martiniquaise de Gérontologie et GériatrieUniversity, hospital or other
- Collaborators
- CHU de Reims
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 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.
This was a prospective multicenter cohort study of elderly people admitted to the acute care for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%).
Detailed description
The SAFMA cohort was an ad hoc study formed into the recruitment of the acute care for elders in the geriatric department of Martinique university Hospitals. The inclusion of subjects ran from January 1st 2012 to June 30th 2012. To be eligible, patients had to be 75 or over and hospitalised for acute condition. Each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was performed by visits and telephone interview till 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A group of elderly people hospitalised in acute care for elders
Key inclusion criteria (3 listed)
- Age of 75 years or over
- Admitted to acute care for elders
- Consent to participate
Key exclusion criteria (2 listed)
- Impossibility to perform the tests
- Refusals to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 6 weeks
Nursing home admission
Time frame: 6 weeks
8 secondary outcomes
Mortality
Time frame: 6 month
Mortality
Time frame: 12 month
Mortality
Time frame: 24 month
Mortality
Time frame: 36 month
Nursing home admission
Time frame: 6 month
Nursing home admission
Time frame: 12 month
Nursing home admission
Time frame: 24 month
Nursing home admission
Time frame: 36 month
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 Aug 2016.
- Results publication: PubMed 26919847Godard-Sebillotte C, Drame M, Basileu T, Fanon JL, Godaert L. Is self-rated health an independent prognostic factor of six-week mortality in older patients hospitalized for an acute condition? Qual Life Res. 2016 Sep;25(9):2335-40. doi: 10.1007/s11136-016-1252-3. Epub 2016 Feb 26.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly People With Polypathology or Disabilities, run by Société Martiniquaise de Gérontologie et Gériatrie.
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 3 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT02871557, 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 18 Aug 2016.