Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis

NCT03981926 | Completed Results DMC

• 2 other identifiers: HS-16-009141R01AR073486-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pragmatic, randomized, controlled, equivalency trial. This 12-month trial will evaluate the impact of an online, team-based connected health (TCH) model for management of atopic dermatitis (AD) as compared to in-person care. 300 patients will be randomly assigned to the online TCH model or the in-person control arm. This pragmatic, randomized trial will compare AD disease severity (Aim 1), quality-of-life and access-to-care measures (Aim 2), and costs (Aim 3) between the two models.

Conditions

Atopic Dermatitis Eczema; Atopic Dermatitis; Eczema

Keywords

Telemedicine; Pragmatic; Equivalency; Skin diseases

Outcome Measures

Primary Outcomes (1)

• Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI)

  EASI combines the assessment of disease severity (erythema, induration, excoriation, and lichenification) and the affected area into a single score between 0 (no disease) to 72 (maximal disease). The primary outcome of the study is the mean improvement in EASI.

  12 months

Secondary Outcomes (8)

• Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA)

  12 months

• Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM).

  12 months

• Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI)

  12 months

• Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y

  12 months

• Access to Care: Transportation

  12 months

Study Arms (2)

In-Person

NO INTERVENTION

In-person care is the control group because it is currently considered the standard of care in delivering dermatologic services. The intervention includes regular visits to a physician, and may include such treatments as ointments, steroids or ultraviolet therapy at the discretion of a physician. In-person care is the major healthcare-delivery model for managing chronic skin diseases and a realistic, primary option that patients face. The patients in the in-person arm can seek atopic dermatitis care from primary care practitioners or dermatologists, just as they would in the real world.

Team-Based Connected Health (TCH)

EXPERIMENTAL

The intervention arm is the team-based connected health (TCH) model, which purports to increase access to specialists and improve outcomes. Specifically, TCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously. TCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists.

Other: Team-Based Connected Health (TCH)

Interventions

Team-Based Connected Health (TCH) OTHER

TCH is an asynchronous, secure online platform where patients can upload images of atopic dermatitis disease and submit assessments. Likewise, practitioners can request and/or initiate dermatology consultations, assume longitudinal care or communicate with patients directly.

Also known as: Online healthcare, Teledermatology

Team-Based Connected Health (TCH)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 1 year or older
• Physician-diagnosed atopic dermatitis (AD)
• Access to a digital-photo capturing device (mobile phone or camera) capable of capturing images with a minimum resolution of 1024x768 pixels
• Access to internet
• Able to establish care or have established care with providers
• Provision of signed and dated informed consent and youth assent form

You may not qualify if:

• Unable to fulfill study-related tasks by adult AD patients or parents or guardians of pediatric AD patients

Sponsors & Collaborators

• University of Southern California: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90089, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: April W. Armstrong, MD, MPH; Professor and Chief of Dermatology
• Organization: University of California, Los Angeles

skinstudy@mednet.ucla.edu

424-365-4129

Study Officials

• April W Armstrong, MD, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of Dermatology

Model Details: This is a pragmatic, randomized, controlled, equivalency trial.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: August 27, 2019
• Primary Completion: February 28, 2024
• Study Completion: May 31, 2024
• Last Updated: October 6, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)