Chikungunya FeverQoLCHIKNCT02901509
Impact of the Chikungunya Outbreak in Reunion Island on the Quality of Life After 10 Years
An observational study of Chikungunya Fever and Quality of Life, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK cohort by comparing scores of SF-36 health survey. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chikungunya Fever, Quality of Life
- How many people
- 386 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to 31 May 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: TELECHIK cohort population drawn for telephone survey
Who may be able to join
- People from the TELECHIK cohort
Who cannot join
- People with other diseases or disorders which could impact quality of life (predefined list)
- Minor
- Elderly over 85 yo
- People with a risk of exposure (in an endemic/epidemic area) after 2005-2006 Reunion Island outbreak
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidémie de Chikungunya à l'île de La Réunion : Effet à Dix Ans de l'Infection Sur la qualité de Vie Dans la Cohorte TELECHIK
QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK cohort by comparing scores of SF-36 health survey.
Read the detailed description
QoLCHIK is a prospective cohort telephone study on the quality of life of people from the TELECHIK cohort, measured by the SF-36 health survey. TELECHIK was a telephone survey conducted 2 years after the 2005-2006 outbreak in Reunion Island and drawn from the SEROCHIK study which aimed at assessing the seroprevalence of chinkungunya over the island between august and october 2006.
A sample of 440 people (220 per group) was calculated and to be drawn from TELECHIK cohort, 220 with a serodiagnosis of chikungunya and 220 with negative serology.
- Conditions
- Chikungunya Fever, Quality of Life
- Keywords
- Chikungunya, Quality of Life
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHIK + | People with chikungunya diagnosis (serodiagnosis) | |
| CHIK - | People without chikungunya diagnosis (negative serology) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score SF-36 health survey
Measured: 1 year
Secondary outcomes (1)
Mean score AQ-5D health survey
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJun 2016
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya FeverStudies 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
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901509
- Sponsor's protocol ID
- 2014/CHU/QoLCHIK
- Acronym
- QoLCHIK
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidémie de Chikungunya à l'île de La Réunion : Effet à Dix Ans de l'Infection Sur la qualité de Vie Dans la Cohorte TELECHIK
- ClinicalTrials.gov ID
- NCT02901509
- Acronym / sponsor ID
- QoLCHIK / 2014/CHU/QoLCHIK
- Conditions
- Chikungunya Fever, Quality of Life
- Keywords
- Chikungunya, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 15 Sep 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.
QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK cohort by comparing scores of SF-36 health survey.
Detailed description
QoLCHIK is a prospective cohort telephone study on the quality of life of people from the TELECHIK cohort, measured by the SF-36 health survey. TELECHIK was a telephone survey conducted 2 years after the 2005-2006 outbreak in Reunion Island and drawn from the SEROCHIK study which aimed at assessing the seroprevalence of chinkungunya over the island between august and october 2006.
A sample of 440 people (220 per group) was calculated and to be drawn from TELECHIK cohort, 220 with a serodiagnosis of chikungunya and 220 with negative serology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHIK + | – | –People with chikungunya diagnosis (serodiagnosis) |
| CHIK - | – | –People without chikungunya diagnosis (negative serology) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TELECHIK cohort population drawn for telephone survey
Key inclusion criteria (1 listed)
- People from the TELECHIK cohort
Key exclusion criteria (4 listed)
- People with other diseases or disorders which could impact quality of life (predefined list)
- Minor
- Elderly over 85 yo
- People with a risk of exposure (in an endemic/epidemic area) after 2005-2006 Reunion Island outbreak
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
Mean score SF-36 health survey
Time frame: 1 year
1 secondary outcome
Mean score AQ-5D health survey
Time frame: 1 year
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 5 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Chikungunya Fever
Active, not recruitingPhase 3
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
Chikungunya Virus
Not yet recruitingPhase 2
Evaluation of IXCHIQ® Vaccine Immunogenicity
Healthy Adult, Healthy Adolescents
RecruitingPhase 4
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
Chikungunya Virus Infection
Recruiting
Against Chikungunya Virus and Neonatal Infection
Chikungunya Virus Infection, Neonatal
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
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 Chikungunya Fever and Quality of Life, 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 4 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 5 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?
Mean score SF-36 health survey (time frame: 1 year). 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 5 Sep 2018.