Condition category
Skin and Connective Tissue Diseases
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
19/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Petra Eland-de Kok

ORCID ID

Contact details

University Medical Center Utrecht (UMCU)
Department of Dermatology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2507348
p.kok@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

We hypothesize that e-health, consisting of internet-guided monitoring and self management training online, for patients with atopic dermatitis (AD) combines cost savings with an improvement in quality of life.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Atopic dermatitis

Intervention

Intervention group: E-health
E-health consists of internet-guided monitoring and self-management training.
Every patient has access to his personal website using a password. The nurse practitioner (NP) has access to this site too.
This personal website contains:
1. General information about atopic dermatitis (AD) and personal information about prescribed treatment and daily skincare
2. Monitoring information: the patient can monitor the disease using digital photographs of the skin, a self score of skin status, visual analogue scale (VAS) scores of sleeping and itching and by keeping a diary of ointment use. The NP uses the data to support patients or parents in self-management by e-mail
3. Offers the possibility for e-mail contact between the patient and NP on all working days
4. Facilitates an assessment of psychosocial aspects and consequences of having AD as part of daily living. The NP can counsel, give information or advice in individual cases.
Follow-up visits to the NP or dermatologist are possible in individual cases where e-health is inadequate.
The control group receives the usual care consisting of scheduled follow-up visits to the dermatologist and the dermatology nurse practitioner.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Direct and indirect costs of care
2. Quality of life

Secondary outcome measures

1. Severity and extent of the AD

Overall trial start date

01/03/2006

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with moderate or severe AD aged 16+ or parents of children aged 0 to 4
2. Who visit the outpatient dermatology department of University Medical Center, Utrecht or Erasmus Medical Center, Rotterdam for the first time
3. Patients who have internet access

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Oral immunosuppressive drugs
2. Ultraviolet -B (UV-B) or ultraviolet -A (UV-A) light therapy

Recruitment start date

01/03/2006

Recruitment end date

01/02/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU), Department of Dermatology and Allergology (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes