NCT01495767

Brief Summary

Data about psychodynamics in uveitis patients are scare. A negative impact of disease is described not only in adult patients with active, but also with quiescent disease. During adolescence even less is known about psychodynamics although this is an especially sensible and challenging stage of life. Given the assumption that juvenile patients with quiescent disease still could suffer from emotional distress, this would require special attention. In this study the investigators evaluate the impact of juvenile uveitis on HRQoL and attempted to identify clinical and demographic factors contributing to an impaired health status. The investigators limit the study to patients with quiescent uveitis and good visual function in at least one eye to exclude additional negative stressors. As there are no validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the investigators use age-appropriate generic instruments. This should allow obtaining an overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether psychological interventions should be offered to this sensitive patient group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

First QC Date

November 27, 2011

Last Update Submit

December 22, 2011

Conditions

Keywords

childhood uveitishealth-related quality of lifegender

Outcome Measures

Primary Outcomes (1)

  • Quality of life as assessed with the "Inventory for Assessing the Quality of Life in Children and Adolescents"

    psychometric inventory

    One day

Secondary Outcomes (1)

  • Quality of life as assessed with the "Children Quality of Life Questionnaire"

    One day

Study Arms (1)

females, males

females: patients of female sex males: patients of male sex

Other: Filling in a psychometric questionnaire

Interventions

Juvenile patients attending the uveitis are asked to fill in a psychometric questionnaire

females, males

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with uveitis, aged 11-18 years

You may qualify if:

  • Patients with uveitis
  • aged 11-18 years
  • willing to participate
  • parent or legal guardian agrees with participation of adolescent

You may not qualify if:

  • not willing to participate
  • parent or legal guardian does not agree with participation of adolescent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

UveitisCoitus

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesSexual BehaviorBehavior

Study Officials

  • Saskia M Maca, MD

    Hospital Hietzing, Vienna + Medical University of Vienna, Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, principal investigator

Study Record Dates

First Submitted

November 27, 2011

First Posted

December 20, 2011

Study Start

January 1, 2006

Study Completion

July 1, 2009

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations