Impact of the Chikungunya Outbreak in Reunion Island on the Quality of Life After 10 Years (QoLCHIK)

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

386

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint Pierre, France, 97448
        • Centre Universitaire de La Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

TELECHIK cohort population drawn for telephone survey

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CHIK +
People with chikungunya diagnosis (serodiagnosis)
CHIK -
People without chikungunya diagnosis (negative serology)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean score SF-36 health survey
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean score AQ-5D health survey
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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