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Innovatie van zorg voor patienten met coeliakie: Een multidisciplinair ICT zelf management systeem.

Innovation in health care for patients with Coeliac Disease: A multidisciplinary ICT self-management system.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24851
Enrollment
300
Registered
2012-10-18
Start date
2012-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Coeliakie is een frequent voorkomende ziekte van de dunne darm en andere organen en dient behandeld te worden met een glutenvrij dieet (GVD). Een GVD is moeilijk te volgen en kan de kwaliteit van leven (quality of life, QoL) beïnvloeden. Follow-up van kinderen met coeliakie bestaat uit jaarlijkse bezoeken aan de polikliniek ter beoordeling van groei, klachten en compliance van het dieet. Innovatie van zorg door middel van een ICT zelf management systeem (ZMS) zal daarom worden geëvalueerd.

Interventions

Randomization into usual care or the SMS. Usual care consists of in-hospital consultations with a paediatrician or paediatric gastroenterologist and measurement of growth and blood values. These visit
2. Evaluation of (compliance to) the GFD
3. Evaluation of growth by measuring weight and length (growth chart)
4. Measurement of CD specific antibodies anti-TG2. The SMS group will be controlled by online questionnaires and at home test of growth and blood values using validated instruments. The SMS care con
2. Growth monitoring using at home measurements and a digital growth analyser
3. Outcome of at home measurement of anti-TG2 using rapid, point of care tests
4. Assessment of adherence to the GFD using an ICT based food questionnaire
5. Assessment of health related QoL using the validated childhood CD-specific instrument CDDUX. The results of the internet based consultation will be processed in a web-based way and evaluated by th
if there are abnormal results, contact with the paediatrician/paediatric gastroenterologist and/or dietician will be scheduled. At the end of the questionnaire there will be the possibility of online

Sponsors

Leiden University Medical Center (LUMC) Dept. of Pediatrics P.O. Box 9600 2300 RC leiden the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with CD, currently attending our outpatient CD clinic and having been diagnosed with CD for at least 1 year, will be asked to participate in the study.

Exclusion criteria

Exclusion criteria: No access to internet and/or difficulty in understanding questionnaires due to cognitive impairment or language problems.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure: disease control assessed by negative TG2 antibodies after 6 months of standard care or SMS. Secondary outcome: patient satisfaction and health related quality of life (QoL).

Secondary

MeasureTime frame
Secondary outcome measures include patient satisfaction assessed by specific questionnaires, including both practical, societal and emotional aspects as well as QoL at time of enrolment and after 6 months. QoL will be assessed using the childhood CD specific ICT-based instrument CDDUX. HUI3 will also be used.

Contacts

Public ContactS.L. Vriezinga

Leiden University Medical Center (LUMC) Dept. of Pediatrics P.O. Box 9600

s.l.vriezinga@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)