NCT02779426

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

May 18, 2016

Last Update Submit

August 21, 2017

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisText MessagesHealth literacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient Satisfaction

    Up to 6 weeks

Study Arms (2)

Text Message Intervention + Standard Care

EXPERIMENTAL

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.

Behavioral: Text messages

Standard Care

NO INTERVENTION

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.

Interventions

Text messagesBEHAVIORAL

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

Text Message Intervention + Standard Care

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center, Department of Dermatology

New York, New York, 10032, United States

Location

Related Publications (4)

  • 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.

    PMID: 25817780BACKGROUND

  • 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.

    PMID: 26616249BACKGROUND

  • 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.

    PMID: 26239125BACKGROUND

  • 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.

    PMID: 25548329BACKGROUND

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

  • Christine Lauren, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

US(1)