Testing an increased visit interval scHeme UsIng web-based Self-evaluation (THUIS-study)

Recruiting

• Conditions: JIA; Juvenile Idiopathic Arthritis; 10003816

• Registration Number: NL-OMON51944
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 85

Inclusion Criteria

-JIA diagnosis of >=1 year
-age 6 - 20 years
-Clinical remission, defined as cJADAS <= 3

Exclusion Criteria

-use of steroids
-not able to read or understand Dutch language
-not able or willing to use e-mail

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the number of disease flares observed at the<br /><br>6-month visit. Disease flares are defined as a JADAS<br /><br>score of higher than 3.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The number of rescheduled visits due to presumed disease worsening as well as<br /><br>the percentage of correctly rescheduled visits (e.g.<br /><br>observation of a flare during the rescheduled visit).<br /><br>- The number of reminders sent for filling out the questionnaires at the 3<br /><br>month moment and the number of patients that fail to home monitor themselves.<br /><br><br /><br>Exploratory outcomes:<br /><br>- Description of events of specific interest during home self-monitoring:<br /><br>presumed medication related events (side effects)<br /><br>- Relationship between JAMAR answers using self-evaluation and active joint<br /><br>count and PGA at the scheduled 6-month visit<br /><br>- Validation of EQ-5D and EQ-VAS score cut-offs as indicators of stable disease.<br /><br>- satisfaction with home monitoring using a separate questionnaire</p><br>