N/A
Completed N=300
Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
Atopic Dermatitis Eczema · Atopic Dermatitis
Source: ClinicalTrials.gov NCT03981926 ↗
Enrolled (actual)
300
Serious AEs
1.0%
Results posted
May 2025
Primary outcomePrimary: Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI) — 4.81; 4.93; 2.70; 2.76 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Disease Severity as Measured by the Eczema Area and Severity Index (EASI) |
4.81; 4.93; 2.70; 2.76 | — |
| SECONDARY Change in Disease Severity as Measured by the Validated Investigator Global Assessment (vIGA) |
2.28; 2.48; 1.71; 1.56 | — |
| SECONDARY Change in Disease Severity as Measured by the Patient-Oriented Eczema Measure (POEM). |
11.7; 11.6; 8.57; 7.70 | — |
| SECONDARY Change in Quality of Life as Measured by the Dermatology Life Quality Index (DLQI) and the Children's Dermatology Quality Index (CDLQI) |
7.73; 8.04; 6.52; 6.10 | — |
| SECONDARY Change in Quality of Life as Measured by the EQ-5D-5L and the EQ-5D-Y |
0.86; 0.85; 0.87; 0.87; 82.6; 82.0 | — |
| SECONDARY Access to Care: Transportation |
12; 9; 131; 139; 7; 1 | — |
| SECONDARY Access to Care: Wait Time |
65.9; 51.6; 30.1; 29.1 | — |
| SECONDARY Change in Healthcare Utilization and Healthcare Costs: Healthcare Utilization |
44.6; 46.0; 51.1; 45.5; 38.1; 36.7 | — |
| SECONDARY Change in Healthcare Utilization and Healthcare Costs: Healthcare Costs |
201.7; 48.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Unable to fulfill study-related tasks by adult AD patients or parents or guardians of pediatric AD patients
Data sourced from ClinicalTrials.gov (NCT03981926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.