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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02901509
Other study ID # 2014/CHU/QoLCHIK
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date May 31, 2018

Study information

Verified date September 2018
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 386
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- People from the TELECHIK cohort

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Universitaire de La Réunion Saint Pierre

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean score SF-36 health survey 1 year
Secondary Mean score AQ-5D health survey 1 year
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