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Implementation of Compliance Improvement for Amblyopia Prevention.


- candidate number2122
- NTR NumberNTR713
- ISRCTNISRCTN22835481
- Date ISRCTN created26-sep-2006
- date ISRCTN requested13-sep-2006
- Date Registered NTR9-jun-2006
- Secondary IDsN/A 
- Public TitleImplementation of Compliance Improvement for Amblyopia Prevention.
- Scientific TitleImplementation of Compliance Improvement for Amblyopia Prevention: further training course about compliance, an effective information programme and direct referral by child health care centres, primary with orthoptists in foreign and low-SES (socio-economic status) neighbourhoods.
- ACRONYMICI-AP.
- hypothesisOrthoptists work effectual by using an improved compliance enhanced programme and a training course on compliance.
- Healt Condition(s) or Problem(s) studiedAmblyopia
- Inclusion criteria1. All newly diagnosed children with an inter-ocular difference in visual acuity of >2 logMAR, strabismus and/or an anisometropia or a deprivation (e.g. cataract); 2. Age: 3 – 6 years; 3. Both genders; 4. Children living in an area with low-SES in the four big cities of the Netherlands.
- Exclusion criteria1. Children with equal visual acuity between the eyes (less than one logMAR line of difference in visual acuity between eyes); 2. Previous treatment for amblyopia, neurological disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-mei-2009
- Target number of participants300
- InterventionsAt end of year one orthoptist receive a three-days training course on compliance with amblyopia prevention. Strategies and techniques to reduce non-compliance are given during the training. All children included in the first year are the control group: receive standard orthoptic care. All children included in the second year is the intervention group: receive the improved educational cartoon story together with a calendar and reward stickers, and a one-page information sheet for the parents. The cartoon is designed as a picture story, without text and is designed from a child’s perspective.
- Primary outcomeWhether the orthoptists work effectual, based on measurements (i.e. questionnaires) at the start of the study, before and after the training course, and at the end of the second year.
- Secondary outcomeThe electronic occlusion measurements for compliance (actual occlusion time / prescribed occlusion time), the fraction realized Child Health Care centre referrals and the overall acuity improvement will be determined.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. H.J. Simonsz
- CONTACT for SCIENTIFIC QUERIES A.M. Tjiam
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryFor one year children are referred as usual from Child Health Care centres (CHC) via the general practitioner to hospitals located in low-SES neighbourhoods to ophthalmologist or orthoptist. Those children get occlusion therapy by the orthoptist as usual. Orthoptic findings and patient flows will be registered, and compliance with occlusion therapy in 3-6 years old children, who are newly diagnosed with amblyopia, will be monitored. A training course on detection and prevention of non-compliance will be developed and given to the orthoptists at the end of year one. In the second year, the implementation phase will follow, where orthoptists will carry out the changings in the primary process i.e. (1) use the information programme, (2) check in the CHC-referrals, (3) pay attention to good communication towards parents, (4) take more measures of information hand outs for foreign parents with low-SES, with support from compliance-predictable software. Primary outcome is whether the orthoptists work effectual, based on measurements at the start of the study, before and after the course, and at the end of the second year. Secondary, the electronic occlusion measurements for compliance, the fraction realized CHC-referrals and the overall acuity improvement will be determined.
- Main changes (audit trail)
- RECORD9-jun-2006 - 27-sep-2006


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