Evaluation of a multidisciplinary ICT SMS for children with CD.
ID
Source
Brief title
Condition
- Malabsorption conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: disease control assessed by negative TG2 antibodies
after 6 months of standard care or SMS.
Secondary outcome
Secondary outcome: patient satisfaction and health related quality of life
(QoL).
Economic evaluation: A cost minimization analysis will be performed from a
societal perspective. Costs of both groups will be compared by assessing costs
of in-hospital versus at home tests and cost and time spent by patients,
parents and physicians. Furthermore, costs of implementation will be assessed.
Background summary
Coeliac disease (CD) is a frequent chronic disease of the small bowel and other
organs, which is treated by a gluten free diet (GFD). A GFD is not easy to
follow and it can affect quality of life (QoL). The usual care in the
Netherlands for children with CD consists of annual hospital visits for
analysis of growth, complaints and compliance to the GFD. Innovation of care by
using an ICT self management system (SMS) will be evaluated.
SMS can lead to efficient and interactive care for CD patients, independent of
time and place. We expect a reduction of health care costs and time spent by
the children, parents and medical specialists. Furthermore, SMS can lead to
more empowerment and increased QoL, which in its turn, can enhance compliance
to the diet and diminish complications. The proposed project is innovative,
since, to our knowledge, there is no similar project anywhere else in the
world.
Study objective
Evaluation of a multidisciplinary ICT SMS for children with CD.
Study design
Randomized controlled trial
Intervention
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. The SMS group will be controlled by
online questionnaires and at home test of growth and blood values using
validated instruments.
Study burden and risks
Instead of hearing history, doing a physical exam with measurement of lenght
and height and drwaing of blood at the outpatient clinic, the subjects will
fill in webbased questionnaires at home on complaints, diet and quality of
life. Furthermore, they will measure their height and lenght at home and will
perform a point of care blood test with a droplet of blood. The burden is
estimated not be higher than the standard care. The subjects in the
intervention group are at risk of failure of the home bloodtesting. In that
case, they will have to go to the hospital. Studies on self management for
adults and adolescents have been performed, not on children under age. Like
adults, children can benefit from implementation of a self management system.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL36534.058.11 |