Innovation in health care for patients with Coeliac Disease: a multidisciplinary ICT self management system.
Recruiting
- Conditions
- coeliac diseasesprue10025477
- Registration Number
- NL-OMON39749
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
Inclusion Criteria
Children and young adults with coeliac disease (CD).
Children attending the outpatient CD clinic of the Leiden University Medical Center LUMC (www.coeliakiepoli.nl) or the pediatric outpatient clinics of Academic Medical Center, Amsterdam; VU Medical Center, Amsterdam; Medical Center Alkmaar, Alkmaar; Rijnland Hospital, Leiderdorp; Rijnstate Hospital, Arnhem; Juliana Childrens' Hospital, The Hague.
Young adults (><= 25 years) attending the outpatient clinic for gastroenterology of the LUMC.
Having been diagnosed with CD for at least 1 year.
Exclusion Criteria
No access to internet.
Difficulty in understanding questionnaires due to cognitive impairment or language problems.
Failure of obtaining informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure: disease control assessed by negative TG2 antibodies<br /><br>after 6 months of standard care or SMS. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome: patient satisfaction and health related quality of life<br /><br>(QoL).<br /><br>Economic evaluation: A cost minimization analysis will be performed from a<br /><br>societal perspective. Costs of both groups will be compared by assessing costs<br /><br>of in-hospital versus at home tests and cost and time spent by patients,<br /><br>parents and physicians. Furthermore, costs of implementation will be assessed.</p><br>