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

May 6, 2023 updated by: Joeri van Straalen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands
        • University Medical Center Utrecht, Wilhelmina Children's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-monitoring arm
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease flares
Time Frame: 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.
5-7 months after inclusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescheduled visits
Time Frame: 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).
Through study completion, an average of 6 months
Disease flares at rescheduled visits
Time Frame: Through study completion, an average of 6 months
The proportion of disease flares observed at rescheduled visits.
Through study completion, an average of 6 months
Adverse events
Time Frame: Through study completion, an average of 6 months
The number and type of adverse events reported during follow-up of home-monitoring patients.
Through study completion, an average of 6 months
Patient satisfaction
Time Frame: 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.
5-7 months after inclusion.
Reminders
Time Frame: Through study completion, an average of 6 months
The number of reminders for home-monitoring (via telephone or e-mail) sent to patients.
Through study completion, an average of 6 months
Failure
Time Frame: 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.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joeri van Straalen

Investigators

  • Principal Investigator: Joost Swart, MD, PhD, Department of Pediatric Immunology and Rheumatology, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL78722.041.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

After publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Self-Evaluation

Clinical Trials on Home-monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe