Community Dwelling Individuals Aged 50 and OverSUCCEEDNCT04603144
Identification of Frailty Predictors of Adverse Health Outcomes in Community-dwelling Individuals Aged 50 and Over
An observational study of Community Dwelling Individuals Aged 50 and Over, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Introduction. Although ageing is a general phenomenon, a great inter individual variability on the quality of ageing can be observed. This substantial heterogeneity may be partly explained by extrinsic factors such as lifestyle, habits, physical activity, diet, which may play an important role in the age-associated… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Community Dwelling Individuals Aged 50 and Over
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 30 Sep 2075
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community-dwelling individuals aged 50 years or over attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France
Who may be able to join
- subjects aged 50 and over previously included in the SUCCEED survey as from 1/1/2010 and being followed up who do not refuse to allow their data to be used for research purposes
- subjects aged 50 and over coming for the first time to the successful ageing clinic who do not refuse to allow their data to be used for research purposes
Who cannot join
- Age below 50y
- Individuals who refuse to allow their data to be used for research purposes
- Legal guardianship
- Subjects not able to understand the study questionnaires, based on investigator's judgement
- Cognitive, mental or psychiatric condition that, based on investigator's judgement, would jeopardise study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
jean-philippe MD DAVID, PhD, +33149813012, Jean-philipppe.david@aphp.fr
About this study
Official title: Identification of Frailty Predictors of Adverse Health Outcomes in Community-dwelling Individuals Aged 50 and Over: the SUCCEED Prospective Cohort
Introduction. Although ageing is a general phenomenon, a great inter individual variability on the quality of ageing can be observed. This substantial heterogeneity may be partly explained by extrinsic factors such as lifestyle, habits, physical activity, diet, which may play an important role in the age-associated declines. The concept of frailty was introduced to account for variability in the aging process. This clinical and biological syndrome reflects a decrease in the physiological reserve, and leads to an insidious, precarious equilibrium that can break down during a stressful life event. In older adults, frailty is known to be associated with an increased risk of adverse outcomes, such as falls, fractures, unplanned hospitalizations, and death. Several frailty domains may only be slightly altered, so that early-stage frailty is not necessarily clinically visible. The most commonly used operational definitions of frailty are based on two different conceptual frameworks. Fried's rules-based criteria correspond to a physical phenotype, whereas the "Rockwood accumulative model" defines frailty as the accumulation of multiple deficits. These tools were built for individuals aged 65 and over. However, frailty can also be found in younger adults. Although the early detection of frailty is potentially important (since the condition might be reversible in its early stages), frailty has not been extensively investigated among middle-aged individuals. Indeed, most of the literature studies have focused on older adults or on a small number of frailty parameters the investigators hypothesized that the factors determining the main ageing-related adverse events are already present in middle age.
The main objectives of the SUCCEED cohort are therefore to 1/investigate the prevalence of frailty parameters in community-dwelling individuals aged 50 and over, 2/ assess the parameters' prognostic value for future adverse health events, 3/ investigate frailty classifications in this population and assess the evolution of profiles over time Method. The SUCCEED survey is a French retrospective and prospective cohort that includes community-dwelling individuals aged 50 years or over consecutively attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France. Baseline parameters are collected using a self-administered questionnaire followed by an interview, physical measurements, and performance tests conducted by trained nurses, and then a standardized clinical evaluation by a geriatrician. This clinical assessment includes evaluation of autonomy, cognition, mood, balance, mobility, muscle strength, nutrition, comorbidities, continence, sensory functions, bone density, sleeping disorders.
Patients who have attended the outpatient clinic from the 01/01/2010 to 14/01/2020 are retrospectively included in the cohort, the other ones are prospectively included.
- Keywords
- ageing, frailty, community dwelling, prevalence, prognosis
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
number of morbid events
occurrence of 1 morbid event defined by the following composite criteria: death or institutionalization or pathological fracture (Pouteau-Colles type wrist, vertebral fracture or compression, femoral neck) or unscheduled hospitalization or non-accidental fall.
Measured: from baseline,during 40 years of follow up maximum
Secondary outcomes (1)
Overall Survival
occurence of Death
Measured: from baseline , during 40 years of follow up maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 Sep 2035 (estimated)
- Study completion30 Sep 2075 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Dwelling Individuals Aged 50 and OverStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603144
- Sponsor's protocol ID
- APHP190906
- Acronym
- SUCCEED
- Status last verified
- Sep 2020
- First submitted
- 9 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Frailty Predictors of Adverse Health Outcomes in Community-dwelling Individuals Aged 50 and Over: the SUCCEED Prospective Cohort
- ClinicalTrials.gov ID
- NCT04603144
- Acronym / sponsor ID
- SUCCEED / APHP190906
- Keywords
- ageing, frailty, community dwelling, prevalence, prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Sep 2035 (estimated)
- Study completion
- 30 Sep 2075 (estimated)
- First posted
- 26 Oct 2020 (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.
Introduction. Although ageing is a general phenomenon, a great inter individual variability on the quality of ageing can be observed. This substantial heterogeneity may be partly explained by extrinsic factors such as lifestyle, habits, physical activity, diet, which may play an important role in the age-associated declines. The concept of frailty was introduced to account for variability in the aging process. This clinical and biological syndrome reflects a decrease in the physiological reserve, and leads to an insidious, precarious equilibrium that can break down during a stressful life event. In older adults, frailty is known to be associated with an increased risk of adverse outcomes, such as falls, fractures, unplanned hospitalizations, and death. Several frailty domains may only be slightly altered, so that early-stage frailty is not necessarily clinically visible. The most commonly used operational definitions of frailty are based on two different conceptual frameworks. Fried's rules-based criteria correspond to a physical phenotype, whereas the "Rockwood accumulative model" defines frailty as the accumulation of multiple deficits. These tools were built for individuals aged 65 and over. However, frailty can also be found in younger adults. Although the early detection of frailty is potentially important (since the condition might be reversible in its early stages), frailty has not been extensively investigated among middle-aged individuals. Indeed, most of the literature studies have focused on older adults or on a small number of frailty parameters the investigators hypothesized that the factors determining the main ageing-related adverse events are already present in middle age.
The main objectives of the SUCCEED cohort are therefore to 1/investigate the prevalence of frailty parameters in community-dwelling individuals aged 50 and over, 2/ assess the parameters' prognostic value for future adverse health events, 3/ investigate frailty classifications in this population and assess the evolution of profiles over time Method. The SUCCEED survey is a French retrospective and prospective cohort that includes community-dwelling individuals aged 50 years or over consecutively attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France. Baseline parameters are collected using a self-administered questionnaire followed by an interview, physical measurements, and performance tests conducted by trained nurses, and then a standardized clinical evaluation by a geriatrician. This clinical assessment includes evaluation of autonomy, cognition, mood, balance, mobility, muscle strength, nutrition, comorbidities, continence, sensory functions, bone density, sleeping disorders.
Patients who have attended the outpatient clinic from the 01/01/2010 to 14/01/2020 are retrospectively included in the cohort, the other ones are prospectively included.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community-dwelling individuals aged 50 years or over attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France
Key inclusion criteria (2 listed)
- subjects aged 50 and over previously included in the SUCCEED survey as from 1/1/2010 and being followed up who do not refuse to allow their data to be used for research purposes
- subjects aged 50 and over coming for the first time to the successful ageing clinic who do not refuse to allow their data to be used for research purposes
Key exclusion criteria (5 listed)
- Age below 50y
- Individuals who refuse to allow their data to be used for research purposes
- Legal guardianship
- Subjects not able to understand the study questionnaires, based on investigator's judgement
- Cognitive, mental or psychiatric condition that, based on investigator's judgement, would jeopardise study participation
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
number of morbid events
Time frame: from baseline,during 40 years of follow up maximum
occurrence of 1 morbid event defined by the following composite criteria: death or institutionalization or pathological fracture (Pouteau-Colles type wrist, vertebral fracture or compression, femoral neck) or unscheduled hospitalization or non-accidental fall.
1 secondary outcome
Overall Survival
Time frame: from baseline , during 40 years of follow up maximum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
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.
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France
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 Community Dwelling Individuals Aged 50 and Over, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Oct 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of morbid events (time frame: from baseline,during 40 years of follow up maximum). 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 26 Oct 2020.