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Transmural occupational care for hand eczema - a randomized controlled trial and cost-effectiveness evaluation


- candidate number3076
- NTR NumberNTR1239
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-feb-2008
- Secondary IDs2008/012 MEC VUMC
- Public TitleTransmural occupational care for hand eczema - a randomized controlled trial and cost-effectiveness evaluation
- Scientific TitleTransmural occupational care for hand eczema - a randomized controlled trial and cost-effectiveness evaluation
- ACRONYMTransmural care for hand eczema
- hypothesisIs transmural care for hand eczema by a specialized multidisciplinary centre (cost)effective as compared to usual care?
- Healt Condition(s) or Problem(s) studiedHand eczema
- Inclusion criteria1. Diagnosis is mild to moderate chronic (>3 months) hand eczema
2. Participants are >16 years
3. Participants are able to complete a Dutch questionnaire
4. Never visited the centre before for hand eczema, or last visit was at least one year ago.
- Exclusion criteria1. Systemic treatment of eczema
2. Generalized eczema, whereas hand eczema is not the main problem
3. Use of medication or phototherapy or than used in this study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2008
- planned closingdate1-mei-2010
- Target number of participants200
- InterventionsMultidisciplinary treatment coordinated by a care manager consists of consults with a dermatologist, a specialized nurse (after 1,2, 4 and 12 weeks) and an occupational physician (if there is a relation with work).
The intervention takes up till 12 weeks. The control group receives standard care provided by a dermatologist. After testing, results will be evaluated and patients will be informed by the dermatologist.
- Primary outcomeCumulative difference in reduction of clinical severity scores
Direct and indirect costs
- Secondary outcomeSpecific Quality of Life,
Clinical score of severity of hand eczema,
Overall Quality of Life
Patient satisfactory with the program
- TimepointsAt baseline and after 4, 12, 26 and 52 weeks
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Robin Gils, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W. Mechelen, van
- Sponsor/Initiator VU University Medical Center, Radboud University Medical Center Nijmegen, University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryHand eczema is a common disease with an unfavourable prognosis. It accounts for 90% of all occupational skin diseases and is in the top three of work-related disorders. Medical consumption, as well as costs related to productivity loss and sick leave, are high. Target of this study is to evaluate the (cost)effectiveness of a multidisciplinary approach coordinated by a care manager, compared to usual care. Patients will be randomly assigned to either the intervention group or the control group. Primary outcome measures are difference in reduction of clinical severity scores and direct and indirect costs. Measurements will take place at baseline and after 4, 12, 26 and 52 weeks. Main research question is: Is transmural care for hand eczema by a specialized multidisciplinary centre aiming at coordination, optimal instruction and treatment (cost)effective as compared to regular dermatologist-led care?
- Main changes (audit trail)
- RECORD18-feb-2008 - 3-apr-2008


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