- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01216059
Text Messaging and Atopic Dermatitis
November 29, 2012 updated by: Amy Paller, Northwestern University
The Use of Text Messages to Improve Adherence to Health Maintenance Behaviors in Adolescents With Atopic Dermatitis
Atopic dermatitis is a common problem faced by patients of all ages and backgrounds.
Treatment regimens and specific therapies may be time consuming and multiple studies have documented a parallel decrease in compliance as time after an office visit increases.
The adolescent population is an extremely challenging sub-group of patients in terms of complying with a treatment regimen.
Not only are they striving for independence and thus lacking supervision of a regimen by a parent, but their complex thinking skills are immature, leading to forgetful behavior.
By introducing a reminder system for these vulnerable patients that is easily incorporated into their daily lives, the investigators propose that patients will have better compliance at applying their medication and thus improving their atopic dermatitis.
Text-messaging via cell phones has become very popular among teenagers and adults and provides a non-obtrusive method of sending a treatment reminder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We propose to conduct a randomized, controlled 6-week trial to evaluate the impact of a text message-based reminder program on adherence to health maintenance behaviors among adolescents diagnosed with Atopic Dermatitis.
After obtaining informed consent, subjects will be randomized into either an intervention or control group.
Subjects in the intervention group will receive a daily text message with a tailored message regarding atopic dermatitis, while control group subjects will receive a weekly text message with information on local weather, sport or news without any reference to atopic dermatitis.
Of note, the decision to send a weekly text message to the control group reflects the expectation that a message will be sent, although the frequency and content of the message will not be revealed.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60614
- Children's Memorial Hospital
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine, Department of Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 10-17 inclusive
- Capable of giving informed consent/assent. Of note, all subjects will sign an assent form and parents will sign a parent consent form.
- Diagnosed with Atopic Dermatitis by a physician (self report)
- IGA score fo 2 or greater
- Currently using at least one prescribed topical therapy for atopic dermatitis
- Have a mobile phone capable of receiving text messages
- Able to retrieve text messages from mobile phone
- Able to adhere to study visit schedule and other protocol requirements.
Exclusion Criteria:
- Younger than 10 years of age or 18 years and older at the time of enrollment
- No diagnosis of atopic dermatitis by a physician
- IGA score of 0 or 1
- Currently on no prescribed topical treatment for atopic dermatitis
- UV therapy or climatotherapy is a part of treatment for atopic dermatitis
- Does not have a mobile phone capable of receiving text messages
- Unable to retrieve text message
- Non-English speaking individuals (text messages are in English)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: Intervention group
Subjects will receive daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study.
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Subjects will receive a daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study
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No Intervention: Control Group
Subjects will receive a weekly text message reminder about pop-culture, sports or weather.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self reported medication adherence
Time Frame: 6 weeks
|
We will assess the difference in number of missed doses of topical medication in the control group (weekly unrelated text message) and the intervention group (daily eczema-related text message group).
All subjects will record missed doses via calendars (diaries).
Those in the intervention group will be able to text on a weekly basis the number of days they forgot their medication that week.
|
6 weeks
|
Change in quality of life
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in AD knowledge score
Time Frame: 6 weeks
|
6 weeks
|
Change in health maintenance behaviors
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 5, 2010
First Posted (Estimate)
October 7, 2010
Study Record Updates
Last Update Posted (Estimate)
December 3, 2012
Last Update Submitted That Met QC Criteria
November 29, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU29486
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.
Clinical Trials on Atopic Dermatitis
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Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
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Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
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ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
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University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
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AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
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SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
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SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
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Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
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Regeneron PharmaceuticalsSanofiRecruitingModerate-to-Severe Atopic Dermatitis | Atopic EczemaUnited States
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University of PennsylvaniaCompletedHIV InfectionsBotswana
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Yaounde Central HospitalCIHR Canadian HIV Trials NetworkCompleted
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Assistance Publique - Hôpitaux de ParisCompletedType 1 DiabetesFrance
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University of California, San DiegoCompleted
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Utah State UniversityCompletedTreatment AdherenceUnited States
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