NCT05603286

Using Self-evaluation to Increase Visit Intervals in Juvenile Idiopathic Arthritis

Testing an Increased Visit Interval scHeme UsIng Web-based Self-evaluation in Patients With Juvenile Idiopathic Arthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Joeri van Straalen · Academic / Other
• Sex: All
• Age: 6 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

In the THUIS study, JIA patients in clinical remission will skip one 3-monthly hospital control visit and instead monitor their disease activity at home. Outcomes at 6 months will be compared to those from a historical cohort.

Detailed description

Background: Children with juvenile idiopathic arthritis (JIA) commonly visit their pediatric rheumatologist every 3 months. This costs time and money for the patient, their parents or guardian, the hospital and other stakeholders. Therefore, the THUIS study aims to demonstrate that JIA patients in clinical remission can safely increase their visit interval by home-monitoring disease activity using the EuroQol five-dimensional youth questionnaire with five levels (EQ-5D-Y-5L) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR). Methods: JIA patients in remission from the Wilhelmina Children's Hospital in Utrecht, the Netherlands, will skip one 3-monthly control visit and instead complete an online EQ-5D-Y-5L and JAMAR questionnaire at home. The home-monitoring results will be evaluated by a research nurse in consultation with the treating pediatric rheumatologist in order to determine if the patient can safely remain at home or has to be planned in for a short-term control visit at the hospital. Primary and secondary outcomes after 6 months will be compared with a historical cohort of matched JIA patients in order to prove non-inferiority.

Conditions

• JIA
• Self-Evaluation

Interventions

Type	Name	Description
PROCEDURE	Home-monitoring	Questionnaires for home-monitoring will be send to the participants 11 weeks after the baseline visit via e-mail using Castor EDC and can be completed using a computer, tablet or smartphone. Home-monitoring can be done together with a parent or guardian, if needed.

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2022-11-02
• Last updated: 2023-05-09

Locations

1 site across 1 country: Netherlands