- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02169986
Atopic Dermatitis Adherence Study
Family Practice Resident Research Project: Do Electronic Reminders Increase Adherence of Moisturizer Utilization in Paediatric Atopic Dermatitis?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1K1
- Dr Bergman's Paediatric Dermatologic Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents/caregivers of children age 10 and under with atopic dermatitis from Dr. Bergman's dermatology clinic.
- The parents/caregivers must have a smartphone and not already be using an electronic reminder system.
- At least one of the parents/caregivers must have an adequate level of English proficiency in order to follow the instructions required by this project mostly because the electronic reminders are available in English only.
Exclusion Criteria:
- All parents/caregivers of children over the age of 10 with atopic dermatitis.
- Patients receiving systemic immunosuppressive therapy.
- Patients who have a documented sensitivity to CeraVe.
- Parents/caregivers unable to follow instructions in English,
- Parents/caregivers without smartphones.
- Parents/caregivers already using electronic reminders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
Parents/caregivers will receive the standard of care.
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Experimental: electronic reminders
In this group, the parents/caregivers will receive two daily electronic reminders in addition to the standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: Effects of electronic reminders on the adherence of 20 parents/caregivers at the end of 28 days study
|
The results on adherence of the 20 parents/caregivers in the experimental arm(using electronic reminders) will be contrasted with another 20 parents/caregivers in the control arm.
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Effects of electronic reminders on the adherence of 20 parents/caregivers at the end of 28 days study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EASI score changes
Time Frame: The EASI score of the patients' eczema will be measured at the beginning and end of the 28 days study
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The differences in the EASI score on both groups can be used as and indirect measurement of the adherence of the parents/caregivers to the treatment.
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The EASI score of the patients' eczema will be measured at the beginning and end of the 28 days study
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Moisturizer
Time Frame: The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment
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The moisturizer jar will be weighted at the beginning and end of the study.
That way the amount of moisturizer will be calculated in grams.
Because the body surface of the patients in both groups will be obtained at the beginning of the study, the amount of moisturizer per surface can be estimated.
If there are significant differences in the use of moisturizer among both groups per unit of surface, this could be used as an indirect measurement of adherence.
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The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James H Bergman, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13-02932
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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