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Completed

NCT Number: NCT05603286

Using Self-evaluation to Increase Visit Intervals in 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.

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Key information

Conditions

JIA Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Self-Evaluation Skin and Connective Tissue Diseases

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht, Wilhelmina Children's Hospital

Utrecht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-monitoring

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Disease flares at rescheduled visits

    Time frame: Through study completion, an average of 6 months

    The proportion of disease flares observed at rescheduled visits.

  3. 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.

  4. 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. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Joeri van Straalen

Other

Registry information

Official study title

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

Acronym: THUIS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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