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

JIA Clinical Trial

— THUIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05603286
• Other study ID #: NL78722.041.21
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2023
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• JIA

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht, Wilhelmina Children's Hospital	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Joeri van Straalen

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Disease flares at rescheduled visits	The proportion of disease flares observed at rescheduled visits.	Through study completion, an average of 6 months
Secondary	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
Secondary	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.
Secondary	Reminders	The number of reminders for home-monitoring (via telephone or e-mail) sent to patients.	Through study completion, an average of 6 months
Secondary	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