E-health in caring for patients with atopic dermatitis. An economic evaluation comparing usual care with internet-guided monitoring and self-management training by a nurse practitioner.

ISRCTN ISRCTN92520775
DOI https://doi.org/10.1186/ISRCTN92520775
Protocol serial number NL556, NTR612
Sponsor University Medical Center Utrecht (UMCU), Department of Dermatology and Allergology (The Netherlands)
Funder Netherlands Organisation for Health Research and Development (ZonMw)
Submission date
19/07/2006
Registration date
19/07/2006
Last edited
08/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Petra Eland-de Kok
Scientific

University Medical Center Utrecht (UMCU)
Department of Dermatology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone +31 (0)30 2507348
Email p.kok@umcutrecht.nl

Study information

Primary study designInterventional
Study designRandomised controlled, parallel group trial
Secondary study designRandomised controlled trial
Scientific titleE-health in caring for patients with atopic dermatitis. An economic evaluation comparing usual care with internet-guided monitoring and self-management training by a nurse practitioner.
Study objectivesWe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAtopic dermatitis
InterventionIntervention 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

1. Severity and extent of the AD

Completion date01/02/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration200
Total final enrolment199
Key inclusion criteria1. 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
Key exclusion criteria1. Oral immunosuppressive drugs
2. Ultraviolet -B (UV-B) or ultraviolet -A (UV-A) light therapy
Date of first enrolment01/03/2006
Date of final enrolment01/02/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2012 08/01/2021 Yes No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.