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Testing an increased visit interval scHeme UsIng web-based Self-evaluation (THUIS-study)

Testing an increased visit interval scHeme UsIng web-based Self-evaluation (THUIS-study) - THUIS-study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51944
Enrollment
85
Registered
2022-01-28
Start date
2022-03-28
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

JIA Juvenile Idiopathic Arthritis

Interventions

There is only one study group. All participant patients will be offered a control interval of 6 months instead of the current 3 months. All patients will complete a JAMAR and EQ-5D-5L-Y questionnair

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: -JIA diagnosis of >=1 year -age 6 - 20 years -Clinical remission, defined as cJADAS

Exclusion criteria

Exclusion criteria: -use of steroids -not able to read or understand Dutch language -not able or willing to use e-mail

Design outcomes

Primary

MeasureTime frame
The main study parameter will be the number of disease flares observed at the 6-month visit. Disease flares are defined as a JADAS score of higher than 3.

Secondary

MeasureTime frame
- The number of rescheduled visits due to presumed disease worsening as well as the percentage of correctly rescheduled visits (e.g. observation of a flare during the rescheduled visit). - The number of reminders sent for filling out the questionnaires at the 3 month moment and the number of patients that fail to home monitor themselves. Exploratory outcomes: - Description of events of specific interest during home self-monitoring: presumed medication related events (side effects) - Relationship between JAMAR answers using self-evaluation and active joint count and PGA at the scheduled 6-month visit - Validation of EQ-5D and EQ-VAS score cut-offs as indicators of stable disease. - satisfaction with home monitoring using a separate questionnaire

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)