UveitisNCT01495767
Quality of Life in Juvenile Patients With Uveitis
An observational study of Uveitis, run by Hospital Hietzing at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Filling in a psychometric questionnaire
- How many people
- 37 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2006to Jul 2009
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with uveitis, aged 11-18 years
Who may be able to join
- Patients with uveitis
- aged 11-18 years
- willing to participate
- parent or legal guardian agrees with participation of adolescent
Who cannot join
- not willing to participate
- parent or legal guardian does not agree with participation of adolescent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Uveitis on Health-related Quality of Life in Adolescents
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.
- Conditions
- Uveitis
- Being tested
- Filling in a psychometric questionnaire
- Keywords
- childhood uveitis, health-related quality of life, gender
- Medical subject headings
- Uveitis, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling in a psychometric questionnaireOther
Juvenile patients attending the uveitis are asked to fill in a psychometric questionnaire
| Study group | Role | What they receive |
|---|---|---|
| females, males | females: patients of female sex males: patients of male sex Receives: Other: Filling in a psychometric questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as assessed with the "Inventory for Assessing the Quality of Life in Children and Adolescents"
psychometric inventory
Measured: One day
Secondary outcomes (1)
Quality of life as assessed with the "Children Quality of Life Questionnaire"
psychometric inventory
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startJan 2006
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Saskia M Maca, Hospital Hietzing
- Investigators
- Saskia M Maca, MD, Principal investigator, Hospital Hietzing, Vienna + Medical University of Vienna, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495767
- Sponsor's protocol ID
- MAC205
- Status last verified
- Dec 2011
- First submitted
- 27 Nov 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Uveitis on Health-related Quality of Life in Adolescents
- ClinicalTrials.gov ID
- NCT01495767
- Acronym / sponsor ID
- MAC205
- Conditions
- Uveitis
- Keywords
- childhood uveitis, health-related quality of life, gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- Jan 2006
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Dec 2011 (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.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| females, males | – | Other: Filling in a psychometric questionnairefemales: patients of female sex males: patients of male sex |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with uveitis, aged 11-18 years
Key inclusion criteria (4 listed)
- Patients with uveitis
- aged 11-18 years
- willing to participate
- parent or legal guardian agrees with participation of adolescent
Key exclusion criteria (2 listed)
- not willing to participate
- parent or legal guardian does not agree with participation of adolescent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filling in a psychometric questionnaireJuvenile patients attending the uveitis are asked to fill in a psychometric questionnaire | Other | females, males |
Primary outcome
Quality of life as assessed with the "Inventory for Assessing the Quality of Life in Children and Adolescents"
Time frame: One day
psychometric inventory
1 secondary outcome
Quality of life as assessed with the "Children Quality of Life Questionnaire"
Time frame: One day
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 23 Dec 2011.
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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.
Saskia M Maca, MD principal investigator
Hospital Hietzing, Vienna + Medical University of Vienna, Vienna
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 Uveitis, run by Hospital Hietzing at 1 site in Austria.
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 4 inclusion and 2 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 23 Dec 2011. 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 Austria. 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?
Quality of life as assessed with the "Inventory for Assessing the Quality of Life in Children and Adolescents" (time frame: One day). 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 23 Dec 2011.