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Atopic Dermatitis Adherence Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169986
Recruitment Status : Unknown
Verified June 2014 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis/Eczema Behavioral: electronic reminders Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Family Practice Resident Research Project: Do Electronic Reminders Increase Adherence of Moisturizer Utilization in Paediatric Atopic Dermatitis?
Study Start Date : August 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
No Intervention: control group
Parents/caregivers will receive the standard of care.
Experimental: electronic reminders
In this group, the parents/caregivers will receive two daily electronic reminders in addition to the standard of care.
Behavioral: electronic reminders



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Moisturizer [ Time Frame: The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment ]
    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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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169986


Contacts
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Contact: James H Bergman, MD 604-876-4433 bergmanjn@gmail.com

Locations
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Canada, British Columbia
Dr Bergman's Paediatric Dermatologic Clinic
Vancouver, British Columbia, Canada, V5Z 1K1
Principal Investigator: James H Bergman, MD RCPSC         
Sub-Investigator: Benedict Yap, MD         
Sub-Investigator: Pedro P Jara Villarroel, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: James H Bergman, MD University of British Columbia
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02169986    
Other Study ID Numbers: H13-02932
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases