Direct-to-patient Teledermatology and Computer-assisted Diagnosis

NCT ID: NCT05128006

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

63200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will examine access to dermatology care. The operational partner will implement a direct-to-new patient teledermatology clinical care pathway while the research will study the effects of that implementation, use data associated with deployment to develop and test an Artificial Intelligence system, and understand key stakeholders' attitudes regarding and readiness for remote dermatology care.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

VA is uniquely positioned to develop and study direct-to-patient teledermatology in parallel with computer vision for skin disease. The following aims will assess the performance of these emerging patient-facing dermatology innovations and assess their ability to improve access to quality skin care VA-wide.

1. Assess the impact of direct-to-patient teledermatology on access and health system utilization. In collaboration with the VA operational partner, Office of Connected Care, the My VA Images app will be deployed to three VA facilities where the app will be introduced as an option to refer eligible new patients for dermatology consultation. Multiple access metrics, including time to consult completion and geographic distance traveled. will be measured in exposed patients and compared with patients referred to usual in-person and consultative teledermatology pathways. Facility-centric measures of access such as clinic appointment wait times and in-person dermatology clinic and community care utilization will also be measured. To better understand end-user experiences, the investigators will survey patients and staff at each study site to evaluate their satisfaction with My VA Images as well as the overall process.
2. Assess, refine and augment computer-assisted evaluation of patient-submitted images. An artificial intelligence-powered computer vision model, trained and validated on clinic-captured images of melanoma and nevi, will be tested and refined on patient-submitted teledermatology images from the My VA images app. The investigators will also extend the computer vision model by using all patient submissions to train and validate the model on a wider variety of skin diagnoses. Patient-submitted teledermatology images at study sites will be prospectively evaluated by the investigators' own computer vision model as well as by a commercial system currently available to VA clinicians and patients, and results will be compared with benchmark diagnoses to measure concordance across a range of diagnostic categories.
3. Assess readiness of VA and Veterans' acceptance to implement direct-to-patient care. The investigators will survey Veterans and key VA leadership and staff at three selected VA facilities, supplemented by interviews of key VA stakeholders, to understand patients' and organizational readiness, including facilitators and barriers, for transitioning to patient-facing technologies in general, and direct-to-patient dermatologic care in particular. National Veteran surveys, and VA Mobile Health user satisfaction data will help place local observations in perspective. Implementation and sustainability of the patient-facing teledermatology app technology will also be measured.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

New Patient Use of Teledermatology Mobile App

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

In-person new VA dermatology patients

In-person dermatology patients that are new patients at three facilities

No interventions assigned to this group

New patient consultative Teledermatology users

New patient consultative Teledermatology users at three facilities

No interventions assigned to this group

New patient Mobile teledermatology users

New patient Mobile teledermatology users at three facilities

New patient teledermatology visit

Intervention Type OTHER

new patient teledermatology visits

In-person new patient in Community Care

In-person new patient in Community Care

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

New patient teledermatology visit

new patient teledermatology visits

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* New patient referrals to dermatology at San Francisco, Decatur, and Aurora from 2021-2025

Exclusion Criteria

* Patients who are not dermatology patients
* Dermatology patients who are not seen at San Francisco, Decatur, and Aurora
* Dermatology patients at San Francisco, Decatur, and Aurora who have visits only before 2021 or after 2025
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Boston Healthcare System

FED

Sponsor Role collaborator

Durham VA Health Care System

FED

Sponsor Role collaborator

Providence VA Medical Center

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dennis H. Oh, MD PhD

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Site Status RECRUITING

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status RECRUITING

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dennis H Oh, MD PhD

Role: CONTACT

(415) 750-2091

Sara B Peracca, PhD MPH MS

Role: CONTACT

(415) 221-4810 ext. 23797

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dennis H Oh, MD PhD

Role: primary

415-750-2091

Sara B Peracca, PhD MPH MS

Role: backup

(415) 221-4810 ext. 23797

Margaret Boyle, MD

Role: primary

303-399-8020

Sara B Peracca, PhD MPH MS

Role: backup

(415) 221-4810 ext. 23797

Howa Yeung

Role: primary

404-321-6111 ext. 203309

Sara B Peracca, PhD MPH MS

Role: backup

(415) 221-4810 ext. 23797

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HX003473

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIR 21-103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stony Brook Telehealth Study
NCT03528850 UNKNOWN NA
Remote Presence Timely Discharge Management
NCT00364117 WITHDRAWN PHASE2/PHASE3