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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR073486-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| April W Armstrong, MD, MPH | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States | ||
| University of California, Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42340708 | Derived | 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 Jun 24. doi: 10.1001/jamadermatol.2026.1959. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | In-Person | 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. |
| FG001 | 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. Team-Based Connected Health (TCH): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 300 patients were enrolled, and 151 patients were randomized to the in-person group and 149 patients were randomized to the online group. Each participant was followed for 12 months. The analyses were based on intention-to-treat.
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| ID | Title | Description |
|---|---|---|
| BG000 | In-Person | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-Person | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary acute pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| April W. Armstrong, MD, MPH; Professor and Chief of Dermatology | University of California, Los Angeles | 424-365-4129 | skinstudy@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2019 | Feb 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2019 | Feb 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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This is a pragmatic, randomized, controlled, equivalency trial.
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|
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| 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. | 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. | 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. | 12 months |
| Access to Care: Transportation | Access-to-care measures include mode of transportation. | 12 months |
| Access to Care: Wait Time | Access-to-care measures include time needed for evaluation. | 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. | 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. | 12 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| BG001 | 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. Team-Based Connected Health (TCH): 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Insurance Type | Count of Participants | Participants |
|
| OG001 | 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. Team-Based Connected Health (TCH): 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. |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Access to Care: Transportation | Access-to-care measures include mode of transportation. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Access to Care: Wait Time | Access-to-care measures include time needed for evaluation. | Posted | Mean | Standard Deviation | minutes | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | minutes | 12 months |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | dollars | 12 months |
|
|
|
| 0 |
| 151 |
| 2 |
| 151 |
| 0 |
| 151 |
| EG001 | 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. Team-Based Connected Health (TCH): 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. | 0 | 149 | 1 | 149 | 0 | 149 |
| Anaphylaxis | Immune system disorders | Systematic Assessment |
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| Tibia fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| VAS Baseline |
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| VAS Month 12 |
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| Walking |
|
| Unknown or Not Reported |
|
| Time per Professional Visit |
|