TeledermatologyNCT00013234
Health Services Implications of a Teledermatology Consult System
A study testing Teledermatology in people with Teledermatology, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Teledermatology
- What is being tested?
- Teledermatology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to Dermatology Consult Service.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health services implications of a teledermatology consult system.
Read the detailed description
Background:
We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health services implications of a teledermatology consult system.
Objectives:
To investigate health services outcomes related to teledermatology implementation. Outcomes of interest were time to diagnosis and treatment initiation, the proportion of patients that avoided the need for a clinic-based encounter, and an economic analysis.
Methods:
Patients referred from the primary care clinics to the dermatology consult service were randomized to either usual care or a teledermatology consultation. A usual care consultation consisted a conventional text-based electronic consult request. A teledermatology consultation included digital images and a standardized history, in addition to the electronic text-based consult. Consultant dermatologists, reviewing the consult requests for both modalities, decided when, and if, a referral required a clinic-based evaluation.
Status:
Final report has been prepared and is in the review process at this time.
- Conditions
- Teledermatology
- Being tested
- Teledermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeledermatologyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: Teledermatology |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TeledermatologyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John D. Whited, MD MHS, Principal investigator, Durham VA Medical Center, Durham, NCEugene Z. Oddone, MD MHSc, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013234
- Sponsor's protocol ID
- IIR 98-159
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Whited JD, Datta S, Hall RP, Foy ME, Marbrey LE, Grambow SC, Dudley TK, Simel DL, Oddone EZ. An economic analysis of a store and forward teledermatology consult system. Telemed J E Health. 2003 Winter;9(4):351-60. doi: 10.1089/153056203772744671.
PubMed 14980092Whited JD. Teledermatology research review. Int J Dermatol. 2006 Mar;45(3):220-9. doi: 10.1111/j.1365-4632.2004.02427.x.
PubMed 16533219Whited JD, Hall RP, Foy ME, Marbrey LE, Grambow SC, Dudley TK, Datta SK, Simel DL, Oddone EZ. Patient and clinician satisfaction with a store-and-forward teledermatology consult system. Telemed J E Health. 2004 Winter;10(4):422-31. doi: 10.1089/tmj.2004.10.422.
PubMed 15689645Whited JD. The quality of telemedicine research. J Telemed Telecare. 2006;12(6):271-3. doi: 10.1258/135763306778558114. No abstract available.
PubMed 17022832Whited JD. Teledermatology. Current status and future directions. Am J Clin Dermatol. 2001;2(2):59-64. doi: 10.2165/00128071-200102020-00001.
PubMed 11705304Whited JD, Hall RP, Foy ME, Marbrey LE, Grambow SC, Dudley TK, Datta S, Simel DL, Oddone EZ. Teledermatology's impact on time to intervention among referrals to a dermatology consult service. Telemed J E Health. 2002 Fall;8(3):313-21. doi: 10.1089/15305620260353207.
PubMed 12419025
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Services Implications of a Teledermatology Consult System
- ClinicalTrials.gov ID
- NCT00013234
- Acronym / sponsor ID
- IIR 98-159
- Conditions
- Teledermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2003 (actual)
- First posted
- 16 Mar 2001 (estimated)
- 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.
We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health services implications of a teledermatology consult system.
Detailed description
Background:
We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health services implications of a teledermatology consult system.
Objectives:
To investigate health services outcomes related to teledermatology implementation. Outcomes of interest were time to diagnosis and treatment initiation, the proportion of patients that avoided the need for a clinic-based encounter, and an economic analysis.
Methods:
Patients referred from the primary care clinics to the dermatology consult service were randomized to either usual care or a teledermatology consultation. A usual care consultation consisted a conventional text-based electronic consult request. A teledermatology consultation included digital images and a standardized history, in addition to the electronic text-based consult. Consultant dermatologists, reviewing the consult requests for both modalities, decided when, and if, a referral required a clinic-based evaluation.
Status:
Final report has been prepared and is in the review process at this time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Teledermatology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred to Dermatology Consult Service.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Teledermatology | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 14980092Whited JD, Datta S, Hall RP, Foy ME, Marbrey LE, Grambow SC, Dudley TK, Simel DL, Oddone EZ. An economic analysis of a store and forward teledermatology consult system. Telemed J E Health. 2003 Winter;9(4):351-60. doi: 10.1089/153056203772744671.
- Results publication: PubMed 16533219Whited JD. Teledermatology research review. Int J Dermatol. 2006 Mar;45(3):220-9. doi: 10.1111/j.1365-4632.2004.02427.x.
- Results publication: PubMed 15689645Whited JD, Hall RP, Foy ME, Marbrey LE, Grambow SC, Dudley TK, Datta SK, Simel DL, Oddone EZ. Patient and clinician satisfaction with a store-and-forward teledermatology consult system. Telemed J E Health. 2004 Winter;10(4):422-31. doi: 10.1089/tmj.2004.10.422.
- Results publication: PubMed 17022832Whited JD. The quality of telemedicine research. J Telemed Telecare. 2006;12(6):271-3. doi: 10.1258/135763306778558114. No abstract available.
- Results publication: PubMed 11705304Whited JD. Teledermatology. Current status and future directions. Am J Clin Dermatol. 2001;2(2):59-64. doi: 10.2165/00128071-200102020-00001.
- Results publication: PubMed 12419025Whited JD, Hall RP, Foy ME, Marbrey LE, Grambow SC, Dudley TK, Datta S, Simel DL, Oddone EZ. Teledermatology's impact on time to intervention among referrals to a dermatology consult service. Telemed J E Health. 2002 Fall;8(3):313-21. doi: 10.1089/15305620260353207.
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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.
John D. Whited, MD MHS principal investigator
Durham VA Medical Center, Durham, NC
Eugene Z. Oddone, MD MHSc principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teledermatology in people with Teledermatology, run by US Department of Veterans Affairs at 1 site 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 0 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013234, which also lists 6 linked publications.
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 7 Apr 2015.