A multi-centered analysis on the effect of eHealth and usual care in IBD patients with peripheral artralgia
- Conditions
- Artralgiajoint complaints1001796910023213
- Registration Number
- NL-OMON43831
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 128
Inclusion Criteria
- Age of 18-70 years old
- IBD patients in clinical remission for at least 6 months (based on the HBI score < 4, fecal calprotectin < 150 µg/g and CRP < 3 mg/L) or endoscopic proven remission in the last 12 months
- Peripheral arthralgia for at least 3 months with a VAS score of at least 40 (out of 100).
- Written informed consent
Exclusion Criteria
- Joint complaints classified as SpA according to the ASAS criteria
- Only axial joint complaints
- Change of smoking habit during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome is the average improvement of coping and quality<br /><br>of life in IBD patients with peripheral arthralgia interventions due to eHealth<br /><br>and usual care in IBD patients with arthralgia. The effects will be measured<br /><br>with VAS coping scores and SF-36 questionnaire. Additionally, the effect of<br /><br>eHealth and usual care on the average pain reduction will be measured with the<br /><br>VAS pain score.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The difference in the average reduction of pain intensity, improvement of<br /><br>coping and the impact of the complaints in daily life between IBD patients with<br /><br>arthralgia who undergo eHealth therapy in combination with usual therapy and<br /><br>IBD patients who undergo just usual care.</p><br>