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Text Messaging and Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message to cell phone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring adherence, text message, reminder, adolescents

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology
  • Children's Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control Group

Arm Description

Subjects will receive daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study.

Subjects will receive a weekly text message reminder about pop-culture, sports or weather.

Outcomes

Primary Outcome Measures

Change in self reported medication adherence
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

Secondary Outcome Measures

Change in AD knowledge score
Change in health maintenance behaviors

Full Information

First Posted
October 4, 2010
Last Updated
November 29, 2012
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01216059
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
adherence, text message, reminder, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects will receive daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects will receive a weekly text message reminder about pop-culture, sports or weather.
Intervention Type
Procedure
Intervention Name(s)
Text message to cell phone
Intervention Description
Subjects will receive a daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study
Primary Outcome Measure Information:
Title
Change in self reported medication adherence
Description
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.
Time Frame
6 weeks
Title
Change in quality of life
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in AD knowledge score
Time Frame
6 weeks
Title
Change in health maintenance behaviors
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Paller, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States

12. IPD Sharing Statement

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Text Messaging and Atopic Dermatitis

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