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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
85
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.
University Medical Center Utrecht, Wilhelmina Children's Hospital
Utrecht, Netherlands
Disease flares
The number of disease flares 6 months after baseline visit. A disease flare is defined as a cJADAS score of \>3.
Time frame: 5-7 months after inclusion.
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).
Time frame: Through study completion, an average of 6 months
Disease flares at rescheduled visits
The proportion of disease flares observed at rescheduled visits.
Time frame: 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.
Time frame: 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.
Time frame: 5-7 months after inclusion.
Reminders
The number of reminders for home-monitoring (via telephone or e-mail) sent to patients.
Time frame: 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.
Time frame: Through study completion, an average of 6 months
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