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WHISTLER-Online


- candidate number4739
- NTR NumberNTR1590
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-dec-2008
- Secondary IDs01-176/K METC
- Public TitleWHISTLER-Online
- Scientific TitleImplementation of a health education and risk prediction program for parents (WHeezing Illnesses STudy LEidsche Rijn (WHISTLER)-online) to reduce ineffective primary health care consumption for respiratory illnesses in children during the first year of life.
- ACRONYMWHISTLER-Online
- hypothesisAn online parent information system reduces ineffective primary health care consumption for respiratory illnesses in children during the first year of life.
- Healt Condition(s) or Problem(s) studiedChildren, Wheezing, Respiratory distress
- Inclusion criteriaEligible for the study are families of healthy infants who participate in WHISTLER.
- Exclusion criteriaExclusion criteria for the WHISTLER-study are gestational age < 36 weeks, major congenital abnormalities and neonatal respiratory disease.
Extra exclusion criteria for WHISTLER-online are the absence of a computer or access to internet or the ignorance of using a computer or internet.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-jul-2012
- Target number of participants700
- InterventionsWHISTLER-online is an internet-based health education program that focuses on knowledge transfer to parents. Besides general information about respiratory illnesses in young children the site contains an individualized section in which parents can introduce risk factors of their own child into a prediction rule, resulting in a semiquantitative risk score for their child. Parents can also introduce actual symptoms and compare these with the symptoms of the other children in WHISTLER at that moment.
- Primary outcomeTo what extent does the implementation of WHISTLER-online change parental behaviour in primary health care visits, as compared to usual care?
- Secondary outcome1. To what extent does the implementation of WHISTLER-online change parental behaviour in terms of demand for drug prescriptions, as compared to usual care?
2. To what extent does the implementation of WHISTLER-online influence cost-effectiveness of respiratory health care, as compared to usual care?
3. What are the main reasons why parents are willing (or not) to use WHISTLER-online in their decision making?
- TimepointsDuring the enrolment session for WHISTLER the WHISTLER-online parents will be introduced into the internet-program and actual baseline-parameters will be introduced together with the researcher. Parents decide themselves whether they want to consult the website or not.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.C. Gugten, van der
- CONTACT for SCIENTIFIC QUERIESProf. dr. C.K. Ent, van der
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications1. Koopman, L. P., Brunekreef, B., de Jongste, J. C. & Neijens, H. J. Definition of respiratory symptoms and disease in early childhood in large prospective birth cohort studies that predict the development of asthma. Pediatr Allergy Immunol 12, 118-124 (2001). 2. Kuehni, C. E., Davis, A., Brooke, A. M. & Silverman, M. Are all wheezing disorders in very young (preschool) children increasing in prevalence? Lancet 357, 1821-1825 (2001). 3. Fuhlbrigge, A. L. et al. The burden of asthma in the United States: level and distribution are dependent on interpretation of the national asthma education and prevention program guidelines. Am. J. Respir. Crit Care Med. 166, 1044-1049 (2002). 4. Guilbert, T. W. et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N. Engl. J Med. 354, 1985-1997 (2006). 5. Johnston, S. L. Macrolide antibiotics and asthma treatment. J. Allergy Clin. Immunol. 117, 1233-1236 (2006). 6. Stein, R. T. & Martinez, F. D. Asthma phenotypes in childhood: lessons from an epidemiological approach. Paediatr. Respir. Rev. 5, 155-161 (2004). 7. Katier, N. et al. The Wheezing Illnesses Study Leidsche Rijn (WHISTLER): rationale and design. Eur. J. Epidemiol. 19, 895-903 (2004). 8. De Jong, B. M. et al. Determinants of health care utilization for respiratory symptoms in the first year of life. Med. Care 45, 746-752 (2007). 9. de Jong, B. M. et al. Respiratory symptoms in young infancy: child, parent and physician related determinants of drug prescription in primary care. Ref Type: Unpublished Work 10. Latzin, P. et al. Prospectively assessed incidence, severity, and determinants of respiratory symptoms in the first year of life. Pediatr. Pulmonol. 42, 41-50 (2007). 11. de Jong, B. M. et al. Respiratory symptoms in young infancy: child, parent and physician related determinants of drug prescription in primary care. Ref Type: Unpublished Work 12. de Jong, B. M. et al. Prediction of lower respiratory illness in the first year of life. 2008. Ref Type: Unpublished Work 13. Grimshaw, J. M. et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol. Assess. 8, iii-72 (2004). 14. Hunink, M. G. Outcomes research and cost-effectiveness analysis in radiology. Eur. J. Radiol. 27, 85-87 (1998). 15. Cohen, M. G. et al. A simple prediction rule for significant renal artery stenosis in patients undergoing cardiac catheterization. Am. Heart J. 150, 1204-1211 (2005). 16. Mokhlesi, B. et al. Predicting extubation failure after successful completion of a spontaneous breathing trial. Respir. Care 52, 1710-1717 (2007). 17. Verbeke, M., Schrans, D., Deroose, S. & De, M. J. The International Classification of Primary Care (ICPC-2): an essential tool in the EPR of the GP. Stud. Health Technol. Inform. 124, 809-814 (2006). 18. Osman, L. M., Baxter-Jones, A. D. & Helms, P. J. Parents' quality of life and respiratory symptoms in young children with mild wheeze. EASE Study Group. Eur. Respir. J. 17, 254-258 (2001). 19. WMA General Assembly. World medical association declaration of Helsinki. Ethical principles for Medical Research Involving Human Subjects. 2004. Tokyo. Ref Type: Report 20. Ministerie van justitie. Wet van 26 februari 1998, houdende regelen inzake medisch-wetenschappelijk onderzoek met mensen (Wet medisch-wetenschappelijk onderzoek met mensen). 1998. 's Gravenhage, De Minister van Justitie, W. Sorgdrager. Ref Type: Report 21. Federatie van medisch wetenschappelijke verenigingen. Code Goed Gebruik. Beknopte versie onderzoekers. 2002. Ref Type: Report 22. Federatie van medisch wetenschappelijke verenigingen. Gedragscode Gezondheidsonderzoek. Gedragscode van de Nederlandse biomedische onderzoeksgemeenschap goedgekeurd door het College Bescherming Persoonsgegevens in 2004. 2005. Zeist. Ref Type: Report 23. CCMO. CCMO-statement publicatiebeleid. 2002. Ref Type: Report 24. De, A. C. et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N. Engl. J. Med. 351, 1250-1251 (2004).
- Brief summaryRationale:
Knowledge about implementation of risk models in health care is mainly restricted to decision-making by care-givers. The effects of implementation of risk-tailored information systems for patients are seldom studied. Respiratory symptoms are common in infancy. Although in the majority of children respiratory symptoms are mild and self-limiting, about 60% of children visit primary care repeatedly and about 40% receive drug prescriptions. Information about disease risks and insight into the severity of actual complaints might help parents in effective health care utilisation. In the Wheezing Illnesses Study in LEidsche Rijn (WHISTLER) we developed and validated an accurate model to predict the development of clinically relevant respiratory disease in children below the age of one year. This model is incorporated in an internet-based parent information system (WHISTLER-online), which also allows parents to compare the severity of actual complaints of their children with actual complaints of age-matched peers and find general information about respiratory illnesses.


Objective:
Before large scale implementation, we aim to study whether such parent information system indeed changes parental help seeking behaviour and to quantify patient outcome and cost-effectiveness.


Study design:
Randomized controlled trial to compare health care utilization of families of 350 children using WHISTLER-online with that of families of 350 children who get usual care.

Study population:
Families of children below the age of one year, participating in the WHISTLER-project.


Intervention:
Implementation of WHISTLER-online in current care.

Main study parameters/endpoints:


Primary outcome:
the number of primary care visits during the first year of life.


Secondary outcomes:
change in parental behaviour in terms of number of required drug prescriptions, cost-effectiveness and attitude of parents to use the program.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will be an extension of the ongoing WHISTLER-project. For WHISTLER-online parents receive a code to log in on the internet site in case of complaints of their child or in case they have questions. This site will support parents in giving information about disease risks and insight into the severity of actual complaints. The study is without any risk, almost all symptoms are self-limiting, less than 1% of the children in the WHISTLER-project required hospitalisation for respiratory illnesses in the first year of life, and alarm symptoms will be clearly described on the website.
- Main changes (audit trail)
- RECORD15-dec-2008 - 10-feb-2009


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