New Patient Use of Teledermatology Mobile AppNCT05128006
Direct-to-patient Teledermatology and Computer-assisted Diagnosis
An observational study of New Patient Use of Teledermatology Mobile App, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- New Patient Use of Teledermatology Mobile App
- What is being tested?
- New patient teledermatology visit
- How many people
- 63,200 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Nov 2022to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients referred as new patients to dermatology at sites in study.
Who may be able to join
- New patient referrals to dermatology at San Francisco, Decatur, and Aurora from 2021-2025
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
About this study
Official title: Improving Dermatology Access by Direct-to-Patient Teledermatology and Computer-Assisted Diagnosis
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.
Read the detailed description
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.
- 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.
- 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.
- 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.
- Being tested
- New patient teledermatology visit
- Keywords
- teledermatology, ehealth, mobile health, telemedicine, artificial intelligence, telehealth, access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New patient teledermatology visitOther
new patient teledermatology visits
| Study group | Role | What they receive |
|---|---|---|
| In-person new VA dermatology patients | In-person dermatology patients that are new patients at three facilities | |
| New patient consultative Teledermatology users | New patient consultative Teledermatology users at three facilities | |
| New patient Mobile teledermatology users | New patient Mobile teledermatology users at three facilities Receives: Other: New patient teledermatology visit | |
| In-person new patient in Community Care | In-person new patient in Community Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
New patient in-person dermatology visits
Proportion of in-person dermatology visits that are for new dermatology patients at facility level
Measured: 4 years
Consult completion time
Total time in days from consult request date to consult completion date, excluding discontinued consults.
Measured: 4 years
Appointment completion time
Total time in days from appointment create date to appointment completed date following (in-person groups).
Measured: 4 years
Travel distance for VA care
Average driving distance from the centroid of the patient's residential zip code to physical location of VA dermatology care. Distances for MVAI cases are defined as zero.
Measured: 4 years
Third next available dermatology clinic appt completion time
Total time in days from appointment create date to third next available clinic appointment date. A forward-looking measure of access. While not as reliable as consult completion time, it is frequently used in VA as a practical forward-looking measure of access.
Measured: 4 years
New Patient Teledermatology encounters
New TD visits as fraction of total encounters at each facility reflecting degree of TD integration.
Measured: 4 years
Organizational Readiness to implement mobile teledermatology for direct new patient care
Using the Organizational Readiness for Implementing Change survey the investigators will attain an overall average score by facility and a score for the 3 facilities in the study combined to indicate organizational readiness to implement a new patient mobile teledermatology. The score is derived from a Likert response scale from 1 to 5. Higher score denotes higher organizational readiness.
Measured: 4 years
Readiness of Veterans to use mobile teledermatology for direct new patient care
The investigators will assess readiness of Veterans to use mobile teledermatology for a new patient visit with a new survey. The investigators will use a 5 point scale, the higher score the greater readiness.
Measured: 4 years
Patient Satisfaction of different types of dermatologic care
Assessment of satisfaction of dermatologic care. A new survey was created with questions regarding ease of care and barriers, for example. The investigators will use a 5-point scale, the higher the score the greater the satisfaction.
Measured: 4 years
Readiness of Veterans to use Artificial Intelligence for dermatologic care
The investigators will assess readiness of Veterans to use Artificial Intelligence for dermatologic care with a new survey. The investigators will use a 5 point scale, the higher score the greater readiness.
Measured: 4 years
Secondary outcomes (2)
Scheduled compared to clinically indicated appointment date
Patient X has a scheduled appointment for x date and clinically indicated date appt was Y so X-Y=Z days. Captures availability in contrast to clinical capacity or clinic booking patterns.
Measured: 4 years
Whether patient had a no-show event for an intended encounter
Yes/No - whether patient had a no-show event for an intended encounter. For MVAI No Show in CDW is an absence of a 304 stop code encounter by the Provider indicated date; in VA Mobile health data, no show equates to an incomplete request by end-date, which should match CDW's provider indicated date.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start7 Nov 2022
- Primary completion31 Aug 2026
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Patient Use of Teledermatology Mobile AppStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 63,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System, Durham VA Health Care System, Providence VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Dennis H. Oh, MD PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128006
- Sponsor's protocol ID
- IIR 21-103
- Other IDs
- 5I01HX003473-02, HX003473
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dermatology Access by Direct-to-Patient Teledermatology and Computer-Assisted Diagnosis
- ClinicalTrials.gov ID
- NCT05128006
- Acronym / sponsor ID
- IIR 21-103
- Keywords
- teledermatology, ehealth, mobile health, telemedicine, artificial intelligence, telehealth, access
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 63,200 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Boston Healthcare System, Durham VA Health Care System, Providence VA Medical Center
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| In-person new VA dermatology patients | – | –In-person dermatology patients that are new patients at three facilities |
| New patient consultative Teledermatology users | – | –New patient consultative Teledermatology users at three facilities |
| New patient Mobile teledermatology users | – | Other: New patient teledermatology visitNew patient Mobile teledermatology users at three facilities |
| In-person new patient in Community Care | – | –In-person new patient in Community Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred as new patients to dermatology at sites in study.
Key inclusion criteria (1 listed)
- New patient referrals to dermatology at San Francisco, Decatur, and Aurora from 2021-2025
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| New patient teledermatology visitnew patient teledermatology visits | Other | New patient Mobile teledermatology users |
Primary outcome
New patient in-person dermatology visits
Time frame: 4 years
Proportion of in-person dermatology visits that are for new dermatology patients at facility level
Consult completion time
Time frame: 4 years
Total time in days from consult request date to consult completion date, excluding discontinued consults.
Appointment completion time
Time frame: 4 years
Total time in days from appointment create date to appointment completed date following (in-person groups).
Travel distance for VA care
Time frame: 4 years
Average driving distance from the centroid of the patient's residential zip code to physical location of VA dermatology care. Distances for MVAI cases are defined as zero.
Third next available dermatology clinic appt completion time
Time frame: 4 years
Total time in days from appointment create date to third next available clinic appointment date. A forward-looking measure of access. While not as reliable as consult completion time, it is frequently used in VA as a practical forward-looking measure of access.
New Patient Teledermatology encounters
Time frame: 4 years
New TD visits as fraction of total encounters at each facility reflecting degree of TD integration.
Organizational Readiness to implement mobile teledermatology for direct new patient care
Time frame: 4 years
Using the Organizational Readiness for Implementing Change survey the investigators will attain an overall average score by facility and a score for the 3 facilities in the study combined to indicate organizational readiness to implement a new patient mobile teledermatology. The score is derived from a Likert response scale from 1 to 5. Higher score denotes higher organizational readiness.
Readiness of Veterans to use mobile teledermatology for direct new patient care
Time frame: 4 years
The investigators will assess readiness of Veterans to use mobile teledermatology for a new patient visit with a new survey. The investigators will use a 5 point scale, the higher score the greater readiness.
Patient Satisfaction of different types of dermatologic care
Time frame: 4 years
Assessment of satisfaction of dermatologic care. A new survey was created with questions regarding ease of care and barriers, for example. The investigators will use a 5-point scale, the higher the score the greater the satisfaction.
Readiness of Veterans to use Artificial Intelligence for dermatologic care
Time frame: 4 years
The investigators will assess readiness of Veterans to use Artificial Intelligence for dermatologic care with a new survey. The investigators will use a 5 point scale, the higher score the greater readiness.
2 secondary outcomes
Scheduled compared to clinically indicated appointment date
Time frame: 4 years
Whether patient had a no-show event for an intended encounter
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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.
Dennis H. Oh, MD PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Patient Use of Teledermatology Mobile App, run by VA Office of Research and Development at 3 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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?
New patient in-person dermatology visits (time frame: 4 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.