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Atopic Dermatitis EczemaTCH in ADNCT03981926

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

A study testing Team-Based Connected Health (TCH) in people with Atopic Dermatitis Eczema and Atopic Dermatitis, run by University of Southern California at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 1 year and older
What is being tested?
Team-Based Connected Health (TCH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesUnited States
Study dates
27 Aug 2019to 31 May 2024
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Southern California

    Los Angeles, California, 90089

  • University of California, Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

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.

Read the detailed description

Skin diseases account for 30% of all physician office visits. In the United States, access to dermatologists remains a significant challenge for those in underserved or rural communities. To increase access to specialists and improve patient outcomes, we will evaluate a team-based connected health (TCH) model that enables structured asynchronous online interactions among patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable effective management of chronic skin diseases via high-quality and efficient online care between providers and patients. TCH purports to bring direct and expedient specialist care to patients and PCPs in a location-independent and asynchronous manner.

Specifically, TCH offers several ways that patients and providers can communicate online asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and (3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access dermatologists online asynchronously for consultations or to request a dermatologist to assume care of the patient's skin disease. With patient-dermatologist interactions, patients can upload clinical images and history online and obtain asynchronous evaluation and recommendations from dermatologists directly. Finally, PCPs have the option of managing their patients' skin diseases online. Importantly, TCH applies efficient workflow that maximally supports providers and fosters multi-directional, informed communication among patients, PCPs, and dermatologists.

To evaluate the impact of TCH, we use atopic dermatitis (AD) as a disease model. AD is a common, relapsing inflammatory skin disease affecting 32 million individuals in the U.S. AD is characterized by intense itching and red, scaly patches. It incurs significant morbidities and high healthcare costs. To address skin inflammation, itch, and psychosocial consequences, PCPs and dermatologists need to adopt a team-based approach to effectively manage all aspects of AD.

The primary goal of the proposed research is to test whether the online TCH model results in equivalent improvements in disease severity and quality of life, provides better access to specialist care, and is cost-saving as compared to usual in-person care in pediatric and adult patients with AD. Specifically, we will conduct a pragmatic, cluster-randomized controlled equivalency trial and use validated measures to compare AD disease severity, health-related quality of life, and access to care between TCH and in-person care. We will also compare costs of the two healthcare delivery models from a societal perspective by conducting cost- minimization and sensitivity analyses.

This proposal evaluates a significant innovation in specialty-care delivery that will likely result in improved patient outcomes, greater access to specialists, and cost savings. The study findings will be highly impactful and have immense dissemination potential to the management of many other chronic diseases.

Being tested
Team-Based Connected Health (TCH)
Keywords
Telemedicine, Pragmatic, Equivalency, Skin diseases
Medical subject headings
Dermatitis, Atopic, Eczema, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Team-Based Connected Health (TCH)Other

    Also called Online healthcare, Teledermatology

    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.

Study groups in NCT03981926
Study groupRoleWhat they receive
In-PersonNo interventionIn-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)ExperimentalThe 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.
Receives: Other: Team-Based Connected Health (TCH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (8)
  1. Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA)

    vIGA is an ordinal scale that provides a global assessment of the patient's AD disease severity. vIGA is scored on a 5-point ordinal scale ranging from 0 (clear) to 4 (severe). The overall change in disease severity for this outcome is measured by calculating the change in vIGA score from baseline averaged across 12 months.

    Measured: 12 months

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

    POEM is a 7-item tool for patient and/or proxy self-completion used to monitor atopic dermatitis severity, focusing on the illness as experienced by the patient. Scores range from 0 (clear) to 28 (very severe). The overall change in disease severity for this outcome will be measured by calculating the change in POEM score from baseline averaged across 12 months.

    Measured: 12 months

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

    The DLQI and the CDLQI are validated, 10-question questionnaires that can be used to assess dermatology-specific quality of life in adults and children with atopic dermatitis. Scores range from 0 to 30, with higher scores indicating more severe impact on quality of life. The overall change in quality of life for this outcome is measured by calculating the change in DLQI / CDLQI from baseline averaged across 12 months.

    Measured: 12 months

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

    EQ-5D-5L and EQ-5D-Y are validated measures of health status. The EQ-5D-5L and the EQ-5D-Y provide an index value that can be used for quality of life and economic evaluations. An index value of 0 represents a health state equivalent to death and an index value of 1 represents full health. The EQ-5D-5L and the EQ-5D-Y also provide a Visual Analogue Score (VAS) where respondents rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health). The overall change in quality of life for this outcome is measured by calculating the change in utility index and VAS from baseline averaged across 12 months.

    Measured: 12 months

  5. Access to Care: Transportation

    Access-to-care measures include mode of transportation.

    Measured: 12 months

  6. Access to Care: Wait Time

    Access-to-care measures include time needed for evaluation.

    Measured: 12 months

  7. Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization

    We will compare differences in healthcare utilization by using the Cornell Services Index (CSI). The CSI is a validated method to assess health service use. Mean time per medical, psychological, and professional visits will be calculated.

    Measured: 12 months

  8. Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs

    We will compare differences in healthcare costs by using the Cornell Services Index (CSI). The CSI is a validated method to assess health service use. Mean out-of-pocket costs across medical, psychological, and professional visits will be calculated.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2019
  2. Study start27 Aug 2019
  3. Primary completion28 Feb 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a pragmatic, randomized, controlled, equivalency trial.
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981926
Sponsor's protocol ID
HS-16-00914
Other IDs
1R01AR073486-01A1
Acronym
TCH in AD
Status last verified
Sep 2025
First submitted
7 Jun 2019
Last updated
6 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Armstrong AW, Roberts AM, Kostandy G, Choudhury F, Yee D, Luu M, Jones ME, Alizadeh ER, Cotliar J, Chren MM, Gelfand JM, Cockburn M, Doctor JN. Online vs In-Person Care for Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2026 Aug 1;162(8):795-803. doi: 10.1001/jamadermatol.2026.1959.

    PubMed 42340708

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