The research question of the underlying study is: What are the effects of GMA*s on children with atopic dermatitis/ food allergy and their parents as compared with individual visits on:- physical complaints- self management- quality of life
ID
Source
Brief title
Condition
- Other condition
- Epidermal and dermal conditions
Synonym
Health condition
voedselallergie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Emotional coping of parents, measured with the in Dutch translated
questionnaire: *Quality of life in parents of children with atopic
dermatitis* . This questionnaire consists of 26 items, divided into 5
subscales: psychosomatic wellbeing, effects on social life, conficence in
medical treatment, emotional coping (primary outcome) and acceptance.
Secondary outcome
Secundary Outcome parameters are:
- Physical complaints (severity and complaints of Atopic dermatitis) measured
by the Self-Administered Eczema Area and Severity Index (SA-EASI) and TARC:
thymus and activation-regulated chemokine
- Self management by JUCKKI-COPECI for children of 8-12 years (36 items) and
the JUCKJU-COPEJU for adolescents of 13-18 years (40 items), with subscales:
o Depressive mood/ social anxiety
o Itch scratch cycle
o Stress
o Catastrophizing cognitions
o Coping cognitions
- anxiety by the State Trait Anxiety Inventory; two subscales: state anxiety
and trait anxiety measured with an adult version for parents and a child
version for children of 8 years up.
Background summary
Atopic Dermatitis is a chronic skin disease, with relapses and remissions. The
prevalence of atopic dermatitis worldwide is estimated at 3-10% (guideline
Atopic Dermatitis 2007). Besides, 30 - 60% of children with Atopic Dermatitis
suffer from food allergy. Because of the food allergy, patients have to follow
diets to prevent (them from) severe and dangerous allergic reactions. Atopic
Dermatitis as well as food allergy have a great impact on quality of life of
the children and their families.
In the last two years, we have developed Group Medical Appointments (GMA*s) for
children and their parents. During a GMA, the child and his parents have a
regular individual appointment in a group, consisting of about 8 patients and
their parents, a dermatologist and a dermatology nurse.
The patients and the members of the multidisciplinary team may give their
reactions on the problem of one of the patients. Thereby, patients and
professionals can learn from each other and help each other. Patients will
become expert patients. The presence of different professionals during the GMA
will be beneficial to patients* knowledge and self management and will
stimulate the complinace to the therapy and the life style adjustmens for the
atopic dermatitis/foodallergy.
Themes during the GMA and individual visits are the same, namely: monitoring of
the severity of the eczema, medical treatment, carrying out the medical
treatment, coping with consequences of eczema in daily life of the children and
their families.
GMA*s were developed in the United States. The Dutch CBO introduced the GMA
concept in the Netherlands. At this moment GMA*s have been implemented in care
for adults and children with different kinds of diseases and experiences are
satisfactory both for caretakers as for caregivers. However, the effects of
GMA*s on patient outcomes are unknown.
We hypothesize that patients and their parents will become better expert
patients by attending GMA*s as compared to individual visits. The child and his
parent will sooner achieve adequate self management, a better quality of life
and a reduction of physical complaints.
Study objective
The research question of the underlying study is: What are the effects of GMA*s
on children with atopic dermatitis/ food allergy and their parents as compared
with individual visits on:
- physical complaints
- self management
- quality of life
Study design
Prospective randomized controlled study
Intervention
In the underlying study Group Medical Appointments (GMA) will be compared with
individual visits. About 6-8 patients and their parents, a dermatology nurse
and a dermatologist will attend the GMA. The programme of a GMA is comparable
to that in the individual visit. Themes during the GMA and individual visits
are: monitoring of the severity of the eczema, medical treatment, carrying out
the medical treatment, coping with consequences of eczema in daily life of the
children and their families.
Study burden and risks
The burden of the study consists of filling out the questionnaires, four times
during one year, about 30 minutes per time. Besides, a Group Medical Appintment
(GMA) takes 45 minutes more than an individual visit. We expect a beneficial
effect of attending the GMA*s: adequate self management, a better quality of
life and a reduction of physical complaints. Ther will be no extra invasive
interventions. There are no risks in participating in the study.
Postbus 85500
3508 Ga Utrecht
NL
Postbus 85500
3508 Ga Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Diagnose Atopic dermatitis/ food allergy
- able to attend the Group Medical Appointments with children and their parents as experts
- ready for randomization
- able to fill in Dutch qustionnaires
- age of child: 0-18
Exclusion criteria
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Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL24802.041.08 |