NCT02901509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 12, 2016

Last Update Submit

September 4, 2018

Conditions

Chikungunya FeverQuality of Life

Keywords

ChikungunyaQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Mean score SF-36 health survey

    1 year

Secondary Outcomes (1)

  • Mean score AQ-5D health survey

    1 year

Study Arms (2)

CHIK +

People with chikungunya diagnosis (serodiagnosis)

CHIK -

People without chikungunya diagnosis (negative serology)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

TELECHIK cohort population drawn for telephone survey

You may qualify if:

  • People from the TELECHIK cohort

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Universitaire de La Réunion

Saint-Pierre, 97448, France

Location

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus InfectionsArbovirus InfectionsVector Borne DiseasesInfectionsMosquito-Borne DiseasesVirus DiseasesTogaviridae InfectionsRNA Virus Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

June 1, 2016

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)