JIA, Self-Evaluation
Conditions
Keywords
Juvenile idiopathic arthritis, Remote monitoring, E-health, Patient-reported outcomes, Disease activity, Healthcare costs, Non-inferiority trial
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.
Interventions
PROCEDUREHome-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.
Sponsors
Joeri van Straalen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease flares | 5-7 months after inclusion. | The number of disease flares 6 months after baseline visit. A disease flare is defined as a cJADAS score of \>3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease flares at rescheduled visits | Through study completion, an average of 6 months | The proportion of disease flares observed at rescheduled visits. |
| Adverse events | Through study completion, an average of 6 months | The number and type of adverse events reported during follow-up of home-monitoring patients. |
| Rescheduled visits | Through study completion, an average of 6 months | 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). |
| Reminders | Through study completion, an average of 6 months | The number of reminders for home-monitoring (via telephone or e-mail) sent to patients. |
| Failure | Through study completion, an average of 6 months | The number of patients that fail to home-monitor after two reminders or withdraw from the study. |
| Patient satisfaction | 5-7 months after inclusion. | Patient satisfaction with home-monitoring, measured using a separate 5-item Likert scale questionnaire with higher scores indicating a better outcome. |
Countries
Netherlands
Outcome results
None listed