Disability or Chronic Disease Leading to DisablementAVIRON-2NCT03357302
Risk Factors Associated With the Global Burden of Disease in Reunion Island and Comparison With Mainland France and Indian Ocean Countries
An observational study of Disability or Chronic Disease Leading to Disablement, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
The question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. Our hypothesis is that these risk factors are of different relative importance in Reunion Island compared to metropolitan France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disability or Chronic Disease Leading to Disablement
- How many people
- 100,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 30 Apr 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population living in Reunion Island
Who may be able to join
- The whole population living in Reunion Island
Who cannot join
- People not living in Reunion Island
Trial locations and contacts
1 site in 1 country.
About this study
The question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. Our hypothesis is that these risk factors are of different relative importance in Reunion Island compared to metropolitan France.
Read the detailed description
The definition of health priorities in a given territory is a major field of Public Health research. The World Health Organization has been conducting the Global Burden of Disease study since the 1990s. This study, which has been the subject of numerous publications, aims at estimating the burden for a given population of different causes of mortality and morbidity. It defines a standardized measure allowing comparisons between different countries. The measure developed internationally is the "Disability-adjusted life year" (DALY). This also allows the monitoring of the relative importance of each pathology. This standardized classification of the relative importance of the pathologies and risk factors involved is a major public health tool.
This measure was developed at the international level initially and then recently applied locally (London neighborhoods, US states). For the Indian Ocean zone, DALY values are available for Madagascar, Seychelles and Mauritius. The estimate of this measure for Reunion Island is based on data from metropolitan France. It therefore uses for Reunion mortality, morbidity, income per capita and social indicators of metropolitan France. It does not take into account the specificities of Reunion. In order to better understand Reunion's public health priorities, it seems important to decline this measure at the regional level. The implementation of this measure at the regional level corresponds to the research project AVIRON which aimed at collecting all the data for the calculation of the DALY in Reunion Island. The AVIRON-2 study, which extends AVIRON's focus on morbidity and mortality, will aim at determining the attributable part of the various disease risk factors and to classify these risk factors according to their importance in a given population for all diseases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of DALY lost for each risk factor
Risk factors associated to the most prevalent diseases
Measured: 2 months after legal and ethical agreements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Dec 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability or Chronic Disease Leading to DisablementStudies 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
- Cross-sectional
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laetitia Huiart, MD, Study director, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357302
- Sponsor's protocol ID
- 2016/CHU/15
- Acronym
- AVIRON-2
- Status last verified
- Sep 2018
- First submitted
- 24 Nov 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated With the Global Burden of Disease in Reunion Island and Comparison With Mainland France and Indian Ocean Countries
- ClinicalTrials.gov ID
- NCT03357302
- Acronym / sponsor ID
- AVIRON-2 / 2016/CHU/15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 29 Nov 2017 (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 question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. Our hypothesis is that these risk factors are of different relative importance in Reunion Island compared to metropolitan France.
Detailed description
The definition of health priorities in a given territory is a major field of Public Health research. The World Health Organization has been conducting the Global Burden of Disease study since the 1990s. This study, which has been the subject of numerous publications, aims at estimating the burden for a given population of different causes of mortality and morbidity. It defines a standardized measure allowing comparisons between different countries. The measure developed internationally is the "Disability-adjusted life year" (DALY). This also allows the monitoring of the relative importance of each pathology. This standardized classification of the relative importance of the pathologies and risk factors involved is a major public health tool.
This measure was developed at the international level initially and then recently applied locally (London neighborhoods, US states). For the Indian Ocean zone, DALY values are available for Madagascar, Seychelles and Mauritius. The estimate of this measure for Reunion Island is based on data from metropolitan France. It therefore uses for Reunion mortality, morbidity, income per capita and social indicators of metropolitan France. It does not take into account the specificities of Reunion. In order to better understand Reunion's public health priorities, it seems important to decline this measure at the regional level. The implementation of this measure at the regional level corresponds to the research project AVIRON which aimed at collecting all the data for the calculation of the DALY in Reunion Island. The AVIRON-2 study, which extends AVIRON's focus on morbidity and mortality, will aim at determining the attributable part of the various disease risk factors and to classify these risk factors according to their importance in a given population for all diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population living in Reunion Island
Key inclusion criteria (1 listed)
- The whole population living in Reunion Island
Key exclusion criteria (1 listed)
- People not living in Reunion Island
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
Quantity of DALY lost for each risk factor
Time frame: 2 months after legal and ethical agreements
Risk factors associated to the most prevalent diseases
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 6 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Laetitia Huiart, MD study director
Luxembourg Institute of Health
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 Disability or Chronic Disease Leading to Disablement, run by Centre Hospitalier Universitaire de la Réunion 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 1 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 6 Sep 2018. 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?
Quantity of DALY lost for each risk factor (time frame: 2 months after legal and ethical agreements). 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 6 Sep 2018.