Condition category
Skin and Connective Tissue Diseases
Date applied
16/03/2014
Date assigned
19/05/2014
Last edited
19/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 doctor’s 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 Children’s 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

http://www.kinderpostzegels.nl/

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

Publication citations

Additional files

Editorial Notes