NCT02169986

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

April 1, 2014

Last Update Submit

June 19, 2014

Conditions

Atopic Dermatitis/Eczema

Outcome Measures

Primary Outcomes (1)

  • Adherence

    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.

    Effects of electronic reminders on the adherence of 20 parents/caregivers at the end of 28 days study

Secondary Outcomes (2)

  • EASI score changes

    The EASI score of the patients' eczema will be measured at the beginning and end of the 28 days study

  • Moisturizer

    The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment

Study Arms (2)

control group

NO INTERVENTION

Parents/caregivers will receive the standard of care.

electronic reminders

EXPERIMENTAL

In this group, the parents/caregivers will receive two daily electronic reminders in addition to the standard of care.

Behavioral: electronic reminders

Interventions

electronic remindersBEHAVIORAL
electronic reminders

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Bergman's Paediatric Dermatologic Clinic

Vancouver, British Columbia, V5Z 1K1, Canada

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • James H Bergman, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James H Bergman, MD

CONTACT

604-876-4433bergmanjn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2014

First Posted

June 23, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

CA(1)