Clinical trial NCT01216059: Text Messaging and Atopic Dermatitis
Official title: The Use of Text Messages to Improve Adherence to Health Maintenance Behaviors in Adolescents With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: adherence
text message
reminder
adolescents
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 26
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in self reported medication adherence
timeFrame: 6 weeks
measure: Change in quality of life
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in AD knowledge score
timeFrame: 6 weeks
measure: Change in health maintenance behaviors
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: