JIATHUISNCT05603286
Using Self-evaluation to Increase Visit Intervals in Juvenile Idiopathic Arthritis
A study testing Home-monitoring in people with JIA and Self-Evaluation, run by Joeri van Straalen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- JIA, Self-Evaluation
- What is being tested?
- Home-monitoring
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- JIA diagnosis of ≥1 year, all subtypes can participate
- Clinical remission, defined as a cJADAS of ≤3
Who cannot join
- Insufficient control of the Dutch language
- Not able or willing to use e-mail
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht, Wilhelmina Children's Hospital
Utrecht
About this study
Official title: 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.
Read the 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.
- Conditions
- JIA, Self-Evaluation
- Being tested
- Home-monitoring
- Keywords
- Juvenile idiopathic arthritis, Remote monitoring, E-health, Patient-reported outcomes, Disease activity, Healthcare costs, Non-inferiority trial
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-monitoringProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Home-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease flares
The number of disease flares 6 months after baseline visit. A disease flare is defined as a cJADAS score of >3.
Measured: 5-7 months after inclusion.
Secondary outcomes (6)
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).
Measured: Through study completion, an average of 6 months
Disease flares at rescheduled visits
The proportion of disease flares observed at rescheduled visits.
Measured: Through study completion, an average of 6 months
Adverse events
The number and type of adverse events reported during follow-up of home-monitoring patients.
Measured: Through study completion, an average of 6 months
Patient satisfaction
Patient satisfaction with home-monitoring, measured using a separate 5-item Likert scale questionnaire with higher scores indicating a better outcome.
Measured: 5-7 months after inclusion.
Reminders
The number of reminders for home-monitoring (via telephone or e-mail) sent to patients.
Measured: Through study completion, an average of 6 months
Failure
The number of patients that fail to home-monitor after two reminders or withdraw from the study.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start28 Mar 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for JIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joeri van Straalen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joeri van Straalen, UMC Utrecht
- Investigators
- Joost Swart, MD, PhD, Principal investigator, Department of Pediatric Immunology and Rheumatology, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603286
- Sponsor's protocol ID
- NL78722.041.21
- Acronym
- THUIS
- Status last verified
- May 2023
- First submitted
- 26 Oct 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data can be provided by the corresponding author upon reasonable request.
Publications
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.
PubMed 33752695Sellies AJ, van Straalen JW, de Joode-Smink GCJ, Doeleman MJH, Jansen MHA, Van Nieuwenhove E, van Royen-Kerkhof A, Vastert BJ, Wulffraat NM, de Roock S, Swart JF. Digital home monitoring in patients with juvenile idiopathic arthritis to increase intervals of hospital visits. Rheumatology (Oxford). 2026 Sep 15:keag444. doi: 10.1093/rheumatology/keag444. Online ahead of print.
PubMed 42742407
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Increased Visit Interval scHeme UsIng Web-based Self-evaluation in Patients With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05603286
- Acronym / sponsor ID
- THUIS / NL78722.041.21
- Conditions
- JIA, Self-Evaluation
- Keywords
- Juvenile idiopathic arthritis, Remote monitoring, E-health, Patient-reported outcomes, Disease activity, Healthcare costs, Non-inferiority trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Joeri van StraalenUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-monitoring arm | Experimental | Procedure: Home-monitoringAfter 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. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- JIA diagnosis of ≥1 year, all subtypes can participate
- Clinical remission, defined as a cJADAS of ≤3
Key exclusion criteria (2 listed)
- Insufficient control of the Dutch language
- Not able or willing to use e-mail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-monitoringQuestionnaires 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. | Procedure or surgery | Home-monitoring arm |
Primary outcome
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.
6 secondary outcomes
Rescheduled visits
Time frame: Through study completion, an average of 6 months
Disease flares at rescheduled visits
Time frame: Through study completion, an average of 6 months
Adverse events
Time frame: Through study completion, an average of 6 months
Patient satisfaction
Time frame: 5-7 months after inclusion.
Reminders
Time frame: Through study completion, an average of 6 months
Failure
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 33752695Doeleman 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.
- Derived from this study: PubMed 42742407Sellies AJ, van Straalen JW, de Joode-Smink GCJ, Doeleman MJH, Jansen MHA, Van Nieuwenhove E, van Royen-Kerkhof A, Vastert BJ, Wulffraat NM, de Roock S, Swart JF. Digital home monitoring in patients with juvenile idiopathic arthritis to increase intervals of hospital visits. Rheumatology (Oxford). 2026 Sep 15:keag444. doi: 10.1093/rheumatology/keag444. Online ahead of print.
- Individual participant dataSharing planned: Yes. Study data can be provided by the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost Swart, MD, PhD principal investigator
Department of Pediatric Immunology and Rheumatology, UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-monitoring in people with JIA and Self-Evaluation, run by Joeri van Straalen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease flares (time frame: 5-7 months after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.