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
Scientific
University Medical Center Utrecht (UMCU)
Department of Dermatology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2507348 |
|---|---|
| p.kok@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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. |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Direct and indirect costs of care |
| Key secondary outcome measure(s) |
1. Severity and extent of the AD |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 199 |
| Key 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 |
| Key exclusion criteria | 1. Oral immunosuppressive drugs 2. Ultraviolet -B (UV-B) or ultraviolet -A (UV-A) light therapy |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.