Atopic Dermatitis/EczemaNCT02169986
Atopic Dermatitis Adherence Study
A study testing electronic reminders in people with Atopic Dermatitis/Eczema, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Atopic Dermatitis/Eczema
- What is being tested?
- electronic reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr Bergman's Paediatric Dermatologic Clinic
Vancouver, British Columbia, V5Z 1K1
James H Bergman, MD RCPSC
Benedict Yap, MD
About this study
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.
Read the 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.
- Conditions
- Atopic Dermatitis/Eczema
- Being tested
- electronic reminders
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic remindersBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: electronic reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: The EASI score of the patients' eczema will be measured at the beginning and end of the 28 days study
Moisturizer
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.
Measured: The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis/EczemaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James H Bergman, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169986
- Sponsor's protocol ID
- H13-02932
- Status last verified
- Jun 2014
- First submitted
- 1 Apr 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Practice Resident Research Project: Do Electronic Reminders Increase Adherence of Moisturizer Utilization in Paediatric Atopic Dermatitis?
- ClinicalTrials.gov ID
- NCT02169986
- Acronym / sponsor ID
- H13-02932
- Conditions
- Atopic Dermatitis/Eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Parents/caregivers will receive the standard of care. |
| electronic reminders | Experimental | Behavioral: electronic remindersIn this group, the parents/caregivers will receive two daily electronic reminders in addition to the standard of care. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic reminders | Behavioural | electronic reminders |
Primary outcome
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.
2 secondary outcomes
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
Moisturizer
Time frame: The use of moisturizer among both groups could be used as an indirect measure of adherence to treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James H Bergman, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic reminders in people with Atopic Dermatitis/Eczema, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James H Bergman, MD (604-876-4433, bergmanjn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Effects of electronic reminders on the adherence of 20 parents/caregivers at the end of 28 days study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.