NCT05603286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

October 26, 2022

Last Update Submit

May 6, 2023

Conditions

JIASelf-Evaluation

Keywords

Juvenile idiopathic arthritisRemote monitoringE-healthPatient-reported outcomesDisease activityHealthcare costsNon-inferiority trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Rescheduled visits

    Through study completion, an average of 6 months

  • Disease flares at rescheduled visits

    Through study completion, an average of 6 months

  • Adverse events

    Through study completion, an average of 6 months

  • Patient satisfaction

    5-7 months after inclusion.

  • Reminders

    Through study completion, an average of 6 months

  • +1 more secondary outcomes

Study Arms (1)

Home-monitoring arm

EXPERIMENTAL

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

Interventions

Home-monitoringPROCEDURE

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.

Home-monitoring arm

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • JIA diagnosis of ≥1 year, all subtypes can participate
  • Clinical remission, defined as a cJADAS of ≤3

You may not qualify if:

  • Insufficient control of the Dutch language
  • Not able or willing to use e-mail

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht, Wilhelmina Children's Hospital

Utrecht, Netherlands

Location

Related 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.

    PMID: 33752695BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Study Officials

  • Joost Swart, MD, PhD

    Department of Pediatric Immunology and Rheumatology, UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Epidemiologist, coordinating researcher

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 2, 2022

Study Start

March 28, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Study data can be provided by the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication.
Access Criteria
Our study data can be of interest to fellow researchers/clinicians within similar areas interested in increasing visit intervals or home-monitoring in general. Pseudonomized data can be shared with them. The data can also be needed to generate new research questions.

Locations

NL(1)