NCT01216059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

October 4, 2010

Last Update Submit

November 29, 2012

Conditions

Atopic Dermatitis

Keywords

adherencetext messagereminderadolescents

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 weeks

  • Change in quality of life

    6 weeks

Secondary Outcomes (2)

  • Change in AD knowledge score

    6 weeks

  • Change in health maintenance behaviors

    6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Text message to cell phonePROCEDURE

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

Intervention group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Amy Paller, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair of Department of Dermatology, Professor of Pediatrics

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 7, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

US(2)