Text Messaging and Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT01216059
First received: October 4, 2010
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Procedure: Text message to cell phone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Use of Text Messages to Improve Adherence to Health Maintenance Behaviors in Adolescents With Atopic Dermatitis

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in self reported medication adherence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in AD knowledge score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in health maintenance behaviors [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Subjects will receive daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study.
Procedure: Text message to cell phone
Subjects will receive a daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study
No Intervention: Control Group
Subjects will receive a weekly text message reminder about pop-culture, sports or weather.

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

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216059

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Amy Paller, MD Northwestern University
  More Information

No publications provided

Responsible Party: Amy Paller, Professor and Chair of Department of Dermatology, Professor of Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01216059     History of Changes
Other Study ID Numbers: STU29486
Study First Received: October 4, 2010
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
adherence
text message
reminder
adolescents

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 29, 2014