Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores

Atopic Dermatitis Clinical Trial

— TADPOLES  

Official title:

Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779426
• Other study ID #: AAAQ7858
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: August 21, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Behavioral:
• Text messages
Daily text messages with information about atopic dermatitis and treatment reminders.

Locations

Country	Name	City	State
United States	Columbia University Medical Center, Department of Dermatology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bass AM, Anderson KL, Feldman SR. Interventions to Increase Treatment Adherence in Pediatric Atopic Dermatitis: A Systematic Review. J Clin Med. 2015 Jan 27;4(2):231-42. doi: 10.3390/jcm4020231. Review. — View Citation

Filanovsky MG, Pootongkam S, Tamburro JE, Smith MC, Ganocy SJ, Nedorost ST. The Financial and Emotional Impact of Atopic Dermatitis on Children and Their Families. J Pediatr. 2016 Feb;169:284-90.e5. doi: 10.1016/j.jpeds.2015.10.077. Epub 2015 Nov 23. — View Citation

Sokolova A, Smith SD. Factors contributing to poor treatment outcomes in childhood atopic dermatitis. Australas J Dermatol. 2015 Nov;56(4):252-7. doi: 10.1111/ajd.12331. Epub 2015 Mar 29. Review. — View Citation

Stockwell MS, Hofstetter AM, DuRivage N, Barrett A, Fernandez N, Vargas CY, Camargo S. Text message reminders for second dose of influenza vaccine: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):e83-91. doi: 10.1542/peds.2014-2475. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EASI Score	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.	Up to 6 weeks
Secondary	Patient Satisfaction	The investigators will assess mean difference in reported satisfaction, as indicated on follow up survey, between arms using t-tests.	Up to 6 weeks