Plain English Summary
Background and study aims
About 20% of children in West-European countries suffer from atopic dermatitis (AD). It is commonly known as eczema, can be due to an allergic reaction and requires intensive treatment.
Shared Medical Appointments (SMAs) are doctors appointments where a group of patients with the same condition are seen together. This can save a lot of time, as the doctor does not have to repeat information relevant to all patients on a one-to-one basis. Our study compares SMAs to one-to-one appointments when treating children with AD.
Our goal is to find out whether SMAs help young patients and their parents to cope better with the disease and have a better quality of life.
Who can participate?
Children with mild to moderate AD, between the ages of 0-18 and a patient at the University Medical Center, Pediatric Dermatology Department, Utrecht, and their parents.
What does the study involve?
Each child and their parents are randomly allocated to one of two groups, SMA or one-to-one consultations. After the consultations, the patients and their parents are asked to complete two questionnaires, one 6 weeks after the consultation and the other after 6 months.
What are the possible benefits and risks of participating?
Possible benefits include a positive effect on coping with the disease and a better quality of life. There are no direct health risks to participating.
Where is the study run from?
The University Medical Center, Utrecht (Netherlands)
When is the study starting and how long is it expected to run for?
From November 2009 to May 2013
Who is funding the study?
The Foundation for Childrens Welfare Stamps (Netherlands)
Who is the main contact?
Professor Suzanne Pasmans
s.pasmans@umcutrecht.nl
Trial website
Contact information
Type
Scientific
Primary contact
Prof Suzanne Pasmans
ORCID ID
Contact details
Contact information on Monday
Wednesday
Thursday and Friday (see also Interventions field):
Erasmus University Medical Center Rotterdam - Sophia Children's Hospital
PO Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0) 10 703 45 80
s.pasmans@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SMA
Study information
Scientific title
A randomised controlled study: effects of shared medical appointments (SMAs) on parental quality of life and disease severity of children with atopic dermatitis
Acronym
SMA
Study hypothesis
Shared Medical Appointments result in greater improvements in disease coping, quality of life and disease severity than individual face-to-face consults.
Ethics approval
1. Medical Ethical Committee of University Medical Center Utrecht, 25/05/2009, 08-368/K
2. Central Committee on Research Involving Human Subjects, 25/05/2009, NL24802.041.08
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Atopic dermatitis (and food allergy within the atopic syndrome)
Intervention
1. Intervention group: three shared medical appointments in the outpatient clinic of Pediatric Dermatology UMC Utrecht
2. Control group: three face-to-face consults in the outpatient clinic of Pediatric Dermatology UMC Utrecht
Contact information for Prof Suzanne Pasmans on Tuesday:
Wilhelmina Children's Hospital
University Medical Centre Utrecht - G02.124
PO Box 85.500
3508 AB Utrecht
Netherlands
Phone: +31 (0) 88 755 73 89
s.pasmans@umcutrecht.nl
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Coping of parents, measured with a subscale of the QoLPAD
All outcomes were measured at baseline, within 2 weeks after the third appointment, at 2 months and at 6 months.
Secondary outcome measures
1. Quality of life of parents, measured with the QoLPAD
2. Severity of eczema, measured with SA-EASI
3. Anxiety to corticosteroids, measured with the State Anxiety scale of the STAI
4. Trait Anxiety, measured with the Trait Anxiety scale of the STAI
Only children 8 or over:
1. Coping with itch, measured with the JUCKKI-JUCKJU
2. Coping with disease, measured with the COPEKI-COPEJU
All outcomes were measured at baseline, within 2 weeks after the third appointment, at 2 months and at 6 months.
Overall trial start date
06/11/2009
Overall trial end date
06/05/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Moderate or severe atopic dermatitis
2. New patient of Pediatric Dermatology Allergology Department of UMC Utrecht
3. Children up to the age of 18
4. Parents are able to speak and write in Dutch
5. Internet access and able to use the Digital Eczema Center Utrecht
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
140
Participant exclusion criteria
Current participation in another study
Recruitment start date
06/11/2009
Recruitment end date
06/05/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Contact information on Monday, Wednesday, Thursday and Friday (see also Interventions field):
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Foundation for Children's Welfare Stamps Netherlands (Stichting Kinderpostzegels Nederland) (Netherlands)
Sponsor details
Schipholweg 73/75
Leiden
2316 ZL
Netherlands
+31 (0) 71 525 98 00
info@kinderpostzegels.nl
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Foundation for Children's Welfare Stamps Netherlands (Stichting Kinderpostzegels Nederland) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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