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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
JIA, Self-Evaluation

Intervention / Treatment
-----------------
* Procedure: Home-monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: JIA diagnosis of ≥1 year, all subtypes can participate Clinical remission, defined as a cJADAS of ≤3 Exclusion Criteria: Insufficient control of the Dutch language Not able or willing to use e-mail

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-monitoring arm<br>After inclusion, participants will skip one regular 3-monthly control visit and instead complete an online EQ-5D-Y-5L and JAMAR questionnaire. 5-7 months after inclusion, participants will be followed-up at the hospital and complete a questionnaire about their experiences with home-monitoring. | Procedure: Home-monitoring<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease flares | The number of disease flares 6 months after baseline visit. A disease flare is defined as a cJADAS score of >3. | 5-7 months after inclusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescheduled visits | The number of rescheduled visits due to presumed disease worsening. Visits can be rescheduled either by the patients themselves or the study team (based on home-monitoring results). | Through study completion, an average of 6 months | 
| Disease flares at rescheduled visits | The proportion of disease flares observed at rescheduled visits. | Through study completion, an average of 6 months | 
| Adverse events | The number and type of adverse events reported during follow-up of home-monitoring patients. | Through study completion, an average of 6 months | 
| Patient satisfaction | Patient satisfaction with home-monitoring, measured using a separate 5-item Likert scale questionnaire with higher scores indicating a better outcome. | 5-7 months after inclusion. | 
| Reminders | The number of reminders for home-monitoring (via telephone or e-mail) sent to patients. | Through study completion, an average of 6 months | 
| Failure | The number of patients that fail to home-monitor after two reminders or withdraw from the study. | Through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile idiopathic arthritis, Remote monitoring, E-health, Patient-reported outcomes, Disease activity, Healthcare costs, Non-inferiority trial