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.
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
- Conditions the study is for
- Atopic Dermatitis Eczema, Atopic Dermatitis, Eczema
- 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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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.
- Conditions
- Atopic Dermatitis Eczema, Atopic Dermatitis, Eczema
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Team-Based Connected Health (TCH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
Access to Care: Transportation
Access-to-care measures include mode of transportation.
Measured: 12 months
Access to Care: Wait Time
Access-to-care measures include time needed for evaluation.
Measured: 12 months
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
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.
- First posted11 Jun 2019
- Study start27 Aug 2019
- Primary completion28 Feb 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, April Armstrong, University of California, Los Angeles
- Investigators
- April W Armstrong, MD, MPH, Principal investigator, University of California, Los Angeles
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03981926
- Acronym / sponsor ID
- TCH in AD / HS-16-00914
- Conditions
- Atopic Dermatitis Eczema, Atopic Dermatitis, Eczema
- Keywords
- Telemedicine, Pragmatic, Equivalency, Skin diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pragmatic, randomized, controlled, equivalency trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Team-Based Connected Health (TCH)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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to fulfill study-related tasks by adult AD patients or parents or guardians of pediatric AD patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-Based Connected Health (TCH)Also: Online healthcare, TeledermatologyTCH 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. | Other | Team-Based Connected Health (TCH) |
Primary outcome
Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI)
Time frame: 12 months
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.
8 secondary outcomes
Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA)
Time frame: 12 months
Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM).
Time frame: 12 months
Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI)
Time frame: 12 months
Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y
Time frame: 12 months
Access to Care: Transportation
Time frame: 12 months
Access to Care: Wait Time
Time frame: 12 months
Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization
Time frame: 12 months
Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42340708Armstrong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April W Armstrong, MD, MPH principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.