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Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores (TADPOLES)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text messages
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Text Messages, Health literacy

Eligibility Criteria

undefined - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Medical Center, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text Message Intervention + Standard Care

Standard Care

Arm Description

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.

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. They will not receive 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2016
Last Updated
August 21, 2017
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT02779426
Brief Title
Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores
Acronym
TADPOLES
Official Title
Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Text Messages, Health literacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Message Intervention + Standard Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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. They will not receive 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.
Intervention Type
Behavioral
Intervention Name(s)
Text messages
Intervention Description
Daily text messages with information about atopic dermatitis and treatment reminders.
Primary Outcome Measure Information:
Title
EASI Score
Description
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.
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
The investigators will assess mean difference in reported satisfaction, as indicated on follow up survey, between arms using t-tests.
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Lauren, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center, Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25817780
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.
Results Reference
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PubMed Identifier
26616249
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.
Results Reference
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PubMed Identifier
26239125
Citation
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.
Results Reference
background
PubMed Identifier
25548329
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.
Results Reference
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Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores

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