Atopic Dermatitis/Eczema Clinical Trial
Official title:
Family Practice Resident Research Project: Do Electronic Reminders Increase Adherence of Moisturizer Utilization in Paediatric Atopic Dermatitis?
Forgetting is usually listed as the most important cause of low adherence among patients. Most studies to date have looked at the adherence of adults or adolescent population. No studies have been done looking specifically at adherence to topical treatment by parents/caregivers of young children. Our project will try to replicate the same results among the parents/caregivers responsible for children ten years and under. The population in this study will be the parents/caregivers of children 10 and under with atopic dermatitis and the intervention will be the effect of electronic reminders in adherence rates for the use of a moisturizer which is recognized as part of the standard of care in the treatment of atopic dermatitis.
Non Adherence to treatment is a common concern among physicians because it is associated
with negative impact on patients' health. Among the different factors that can explain why
treatment adherence is so low, forgetfulness is the most common.
Several interventions have been put into practice. Some of them have been proven to be
successful, others not. An effective intervention not only has to be successful but also
practical.
Technology is an integral part of our everyday lives. In Canada, most adults have access to
smartphones, which opens the door to a world of new innovations. Among these are useful
applications designed to improve different aspects of every day life.
Electronic reminders are applications designed to send messages, which could improve the
adherence to treatment. So far, there are several studies that have proven this benefit in
older children and adult population. At this moment, there are no studies involving younger
children. Therefore, in this study, the null hypothesis is that electronic reminders will
improve the adherence to twice daily application of moisturizers among parents/caregivers of
children 10 and under with atopic dermatitis.
The study population will be parents/caregivers of children age 10 and under with atopic
dermatitis recruited from Dr. Bergman's paediatric dermatology clinic.
The parents/caregivers of the patients will be invited to participate in this project by the
Medical Office Assistant who will send them a letter with the invitation one week before
their scheduled appointment. If they agree to participate, they will be asked to sign a
consent form and then they will be asked to select an unmarked envelope from a container.
The envelopes contain the information for two different groups, one is the experimental and
the other the control group.
The experimental group will have the extra task of downloading and utilizing an application
called MediSafe. This application will be set up to send reminders two times per day. The
control group will be encouraged to continue with the standard of care with no added
intervention. Both groups will received a free unlabeled bottle of CeraVe cream. The
moisturizer will be unlabeled so as not to allow parents/caregivers perceptions on a
specific brand to affect their utilization. External forces such as advertising the
parents/caregivers sees or cost of the product could affect the parents/caregivers
perception of value and in turn affect adherence.
The parents/caregivers will also receive a calendar in which they have to mark every time
their children have moisturizer applied. The calendar will be provided as label on the
bottle of moisturizer.
If during the study period the parents/caregivers run out of moisturizer, they can return to
the clinic to pick up extra bottles of moisturizer at no cost.
The atopic dermatitis of patients from both groups will be assessed using the EASI score at
the beginning and at the end of the 28 days.
Additionally, the parents/caregivers of both groups will be asked to fill up a brief survey
form. They will submit this form, along with the calendar label, in an unmarked envelope to
maintain anonymity.
The bottles of moisturizer will be weighed before and after the study and also every time a
refill of moisturizer is required, to determine the amount of moisturizer used by each
group.
This study will follow the standard of care for treatment of atopic dermatitis; no treatment
will be withheld.
The principal outcome of this study is to probe whether or not electronic reminders can
improve the adherence of moisturizer use in parents/caregivers of children 10 years and
under with atopic dermatitis. The changes in the EASI score of the patients after the study
and the differences in the amount of moisturizer used per body surface area will be
secondary outcomes.
The number of times the calendar label will be marked will reflect the adherence to the
treatment. Other data such as severity of eczema, and amount of moisturizer used will be
collected. The height, weight, severity of eczema and use of steroid/calcineurin inhibitors
will provide additional information that could be used indirectly to measure adherence.
Regarding the data analysis:
Mean differences between the experimental and control groups on adherence and EASI scores
will be analyzed using Student's t-test for independent groups. Possible difference on
treatment compliance between baseline and post-implementation within the groups will be
explored using Student's dependent t-test for paired samples. This pilot study's sample size
will be sufficient for the planned analyses, and to help determine effect size and power
needed to conduct a larger study on this topic. Univariate descriptive statistics will be
reported for all variables.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03003793 -
Insulin Sensitivity in Patients With Atopic Dermatitis
|