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

Primary Purpose

JIA, Self-Evaluation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Home-monitoring
Sponsored by
Joeri van Straalen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for JIA focused on measuring Juvenile idiopathic arthritis, Remote monitoring, E-health, Patient-reported outcomes, Disease activity, Healthcare costs, Non-inferiority trial

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Utrecht, Wilhelmina Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-monitoring arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease flares
The number of disease flares 6 months after baseline visit. A disease flare is defined as a cJADAS score of >3.

Secondary Outcome Measures

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).
Disease flares at rescheduled visits
The proportion of disease flares observed at rescheduled visits.
Adverse events
The number and type of adverse events reported during follow-up of home-monitoring patients.
Patient satisfaction
Patient satisfaction with home-monitoring, measured using a separate 5-item Likert scale questionnaire with higher scores indicating a better outcome.
Reminders
The number of reminders for home-monitoring (via telephone or e-mail) sent to patients.
Failure
The number of patients that fail to home-monitor after two reminders or withdraw from the study.

Full Information

First Posted
October 26, 2022
Last Updated
May 6, 2023
Sponsor
Joeri van Straalen
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1. Study Identification

Unique Protocol Identification Number
NCT05603286
Brief Title
Using Self-evaluation to Increase Visit Intervals in Juvenile Idiopathic Arthritis
Acronym
THUIS
Official Title
Testing an Increased Visit Interval scHeme UsIng Web-based Self-evaluation in Patients With Juvenile Idiopathic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joeri van Straalen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
JIA, Self-Evaluation
Keywords
Juvenile idiopathic arthritis, Remote monitoring, E-health, Patient-reported outcomes, Disease activity, Healthcare costs, Non-inferiority trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-monitoring arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Home-monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease flares
Description
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.
Secondary Outcome Measure Information:
Title
Rescheduled visits
Description
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
Title
Disease flares at rescheduled visits
Description
The proportion of disease flares observed at rescheduled visits.
Time Frame
Through study completion, an average of 6 months
Title
Adverse events
Description
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
Title
Patient satisfaction
Description
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.
Title
Reminders
Description
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
Title
Failure
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost Swart, MD, PhD
Organizational Affiliation
Department of Pediatric Immunology and Rheumatology, UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Utrecht, Wilhelmina Children's Hospital
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33752695
Citation
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.
Results Reference
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Using Self-evaluation to Increase Visit Intervals in Juvenile Idiopathic Arthritis

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