1) To develop and implement a protocol for transmural, multidiscplinary care for hand eczema, coordianted by a case-manager.2) To evaluate the (cost)effectiveness of the multidisciplinary protocol for transmural care in hand eczema
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Cumulative difference in reduction of clinical scores of hand eczema
Measured using the Hand Eczema Severity Index (HECSI)
2) Direct and indirect costs
Measured using a questionnaire, filled out every three months
Secondary outcome
1) Specific quality of life
Measured using the Imapct of chronic Skin Disease on daily Life (ISDL) and the
Skindex
2) Clinical scores of hand eczema
Measured using the Hand Eczema Area and Severity score (HEAS) and the
Photographic Guide
3) Overaal quality of life
Measured using the EuroQol
4) Patient satisfactory
Measured using the Patient Satisfaction with Occupational Health Services
(PSOHQ)
Background summary
Hand eczema is defined as an inflammation of the skin that is confined to the
hands. It is a common disease, accounting for 90% of all work-related skin
diseases. It is in the top-three of work-related disorders. Prevalence ranges
from 25 to 66 per 1000 patient years. Point prevalence varies from 5 to 10% and
incidence rates from 4 to 7%. Hand eczema has an unfavourable prognosis; 5
years after diagnosis, 50% of all patients reports mild to moderate and 32%
severe hand eczema. It is also associated with high medical consumption. 60% of
all patients visit their general practitioner and 20% visits a medical
specialist. High costs are also related to productivity loss and sick leave.
Total costs of medical consumption, absenteeism and disability pensions due to
occupational skin disease were estimated at ¤98,1 million in 2001.
Usual care of hand eczema by a dermatologist is lacking. In this randomized,
controlled trial, usual care is compared to a transmural multidisciplinary
treatment, coordinated by a case-manager. Cost-effectiveness of this new
approach is also evaluated.
Study objective
1) To develop and implement a protocol for transmural, multidiscplinary care
for hand eczema, coordianted by a case-manager.
2) To evaluate the (cost)effectiveness of the multidisciplinary protocol for
transmural care in hand eczema
Study design
This study is designed as a randomized controlled trial. Patients are randomly
assigned to the intervention group or the control group after baseline
measurements. Groups will receive the following care:
- Intervention group: Patients will be diagnosed and will receive coordinated
care from a multidisciplinary team, consisting of a case manager, a
dermatologist, an occupational physician and a specialized nurse.
- Control group: Patients receive usual care, consisting of
allergic-dermatological evaluation by their own dermatologist and usual
medication, written information and advice.
The economic evaluation will be conducted from a societal perspective. Both
medical costs (direct costs) and costs due to productivityloss (indirect costs)
will be measured.
Het onderzoek is opgezet als een gerandomiseerde gecontroleerde trial. De
patiënt wordt na de baseline meting willekeurig aan de interventie- of de
controlegroep toegewezen. De groepen ontvangen de volgende zorg:
- Interventiegroep: De patiënt ontvangt gerichte diagnostiek en gecoördineerde
zorg van een multidisciplinair team, bestaande uit een case manager, een
(arbeids)dermatoloog, een klinisch arbeidsgeneeskundige en een gespecialiseerd
verpleegkundige.
- Controlegroep: De patiënt ontvangt *usual care*, bestaande uit
allergo-dermatologische evaluatie door de eigen dermatoloog en gebruikelijke
medicatie, schriftelijke informatie en adviezen.
Intervention
The intervention group will receive care of a multidisciplinary team,
consisting of a dermatologist, a specialized nurse and an occupational
physician.
The dermatologist does the allergic-dermatological test and the end-evaluation.
The specialized nurse teaches the causes and mechanism that play a role in hand
eczema. She discusses the therapy and patients consult her at set times. In
emergency cases the specialized nurse could be consulted temporary.
The occupational physician is consulted if hand eczema is work-related. He
lalso plays a role when patients need assistance considering social
regulations. The occupational physician is the link between the hospital and
the workplace of the patient. He gathers information about exposure to allergic
substances and collects materials needed for the allergic-dermatological tests.
The occupational pfysician visits the workplace if indicated.
The control group receives care by the dermatologist only. As in the
intervention group, allergic-dermatological tests are performed. The
dermatologist informs the patient about the results and provides the patient
with information brochures.
Study burden and risks
Measurements will take place at baseline and after 4, 12, 26 and 52 weeks.
Every measurement (existing of scoring clinical hand eczema and filling out a
questionnaire) will take about 1 hour. Besides that, participants keep record
of usage of care and absenteeism from work.
There will be no extra physical burden for patients in the intervention group.
There is no higher risk in participating
van der Boechorststraat 7
1081 BT Amsterdam
Nederland
van der Boechorststraat 7
1081 BT Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Moderate to severe chronic (>3 months) hand eczema
Participants are at least 16 years old
Participants are able to complete a Dutch questionnaire
Exclusion criteria
Systemic treatment of hand eczema
Generalized eczema, when hand eczema is not the main issue
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL21490.029.08 |