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Completed

NCT Number: NCT02779426

Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores

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.

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Key information

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center, Department of Dermatology

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Text Messages

Behavioral

Daily text messages with information about atopic dermatitis and treatment reminders.

Primary outcomes

  1. EASI Score

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: Up to 6 weeks

    The investigators will assess mean difference in reported satisfaction, as indicated on follow up survey, between arms using t-tests.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Acronym: TADPOLES

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 20, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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