Clinical trial NCT05603286: Using Self-evaluation to Increase Visit Intervals in Juvenile Idiopathic Arthritis
Official title: Testing an Increased Visit Interval scHeme UsIng Web-based Self-evaluation in Patients With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: JIA
Self-Evaluation
Keywords: Juvenile idiopathic arthritis
Remote monitoring
E-health
Patient-reported outcomes
Disease activity
Healthcare costs
Non-inferiority trial
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 85
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Disease flares
timeFrame: 5-7 months after inclusion.
Secondary outcomes:
measure: Rescheduled visits
timeFrame: Through study completion, an average of 6 months
measure: Disease flares at rescheduled visits
timeFrame: Through study completion, an average of 6 months
measure: Adverse events
timeFrame: Through study completion, an average of 6 months
measure: Patient satisfaction
timeFrame: 5-7 months after inclusion.
measure: Reminders
timeFrame: Through study completion, an average of 6 months
measure: Failure
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht, Wilhelmina Children's Hospital
Study officials:
affiliation: Department of Pediatric Immunology and Rheumatology, UMC Utrecht
name: Joost Swart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doeleman MJH, de Roock S, Buijsse N, Klein M, Bonsel GJ, Seyfert-Margolis V, Swart JF, Wulffraat NM. Monitoring patients with juvenile idiopathic arthritis using health-related quality of life. Pediatr Rheumatol Online J. 2021 Mar 22;19(1):40. doi: 10.1186/s12969-021-00527-z.