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

Innovation in health care for patients with Coeliac Disease: a multidisciplinary ICT self management system. - Self management system coeliac disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39749
Enrollment
320
Registered
2012-01-18
Start date
2012-04-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

coeliac disease sprue

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. The SMS g

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

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 (>

Exclusion criteria

Exclusion criteria: No access to internet. Difficulty in understanding questionnaires due to cognitive impairment or language problems. Failure of obtaining informed consent.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure: disease control assessed by negative TG2 antibodies after 6 months of standard care or SMS.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)