Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Behavioral: Text messages

• Registration Number: NCT02779426
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this study is to determine if sending text messages with treatment reminders and facts regarding atopic dermatitis (AD) to caretakers of children with AD will have a positive effect on the disease severity.

Detailed Description

Atopic dermatitis (AD) is a common, chronic, and debilitating disease that tends to present in children under age 2 and has a waxing and waning course. Poor adherence to treatment is the primary preventable contributor towards adverse outcomes such as infection, hospitalization, permanent disfigurement, and disruptions in normal childhood psychological development. The burden of care for these patients often falls upon parents, who may have difficulty incorporating the necessary daily treatments into the family's lifestyle. Thus, investigating ways of improving adherence could have a significant impact on a patient's long term prognosis and the family's ability to understand and adjust to the demands of AD.Text message reminders with embedded health literacy information have been shown to improve vaccination rates in children and caregivers have reported increased satisfaction with this means of communication.

This study aims to assess whether text message reminders with information about AD are an effective way to improve treatment adherence and provide disease specific information to caregivers of children with AD. The measure of AD severity will be the Eczema Area and Severity Index (EASI) score. Health literacy with regard to AD will be assessed via in-office survey.This study will involve children age 0-6 with newly diagnosed AD and their primary caregivers. The subjects will be randomized to standard care or text message reminder group. All study participants will be asked to complete a survey after their initial evaluation and after their follow up visit on the same day they are in the office. The text message group will receive text messages with information and treatment reminders. All participants will receive the standard of care with regard to AD.

If this study demonstrates that text message reminders can improve EASI scores in AD patients it could lead to a significant change in how these patients are managed. Fewer complications from episodic flares, infections, and other sequelae may lessen the burden of this disease for both patients and their caregivers. Text messaging is an inexpensive, noninvasive, and broadly applicable tool that is worth studying for the purpose of improving treatment adherence and disease literacy.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• New clinical diagnosis of atopic dermatitis
• New patient to Columbia University Medical Center, Department of Dermatology
• Caregiver has mobile that can send/receive text messages

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Exclusion Criteria

• Age over 7 years
• Caregiver is not fluent English speaker
• Those patients in which a definitive diagnosis of atopic dermatitis cannot be made
• Any individual who declines participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text Message Intervention + Standard Care	Text messages	Enrolled patients and their caregivers who are randomized to this group will receive the usual standard of care for atopic dermatitis patients treated at this institution as well as daily text messages with information about atopic dermatitis and treatment reminders. 1-2 times/week they will receive a message asking if they were able to complete their treatments in the last day. They will respond with 1=yes, 2=no, 3= I have questions about the treatment. Those who respond with 3 will be sent the contact information for the office. No other communications will be sent through text messages. Caregivers will take two in-office surveys: one upon enrollment, and one follow-up survey at the follow-up visit. Patient EASI Score will be assessed by the pediatric dermatologist and initial and follow up exam.

Primary Outcome Measures

Name	Time	Method
EASI Score	Up to 6 weeks	Patient EASI Score (0-72) will be determined at initial and follow up exam. Mean differences in EASI scores between arms will be assessed using t-tests since EASI scores are used to measure the severity of a patient's atopic dermatitis.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	Up to 6 weeks	The investigators will assess mean difference in reported satisfaction, as indicated on follow up survey, between arms using t-tests.

Trial Locations

Locations (1)

Columbia University Medical Center, Department of Dermatology; 🇺🇸 New York, New York, United States