Atopic DermatitisNCT00985894
Comparison Between Asynchronous Online Care Model With Usual In Office Care for the Management of Atopic Dermatitis
A study testing Online Teledermatology Care and Conventional in Office Care in people with Atopic Dermatitis, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of atopic dermatitis. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Online Teledermatology Care and Conventional in Office Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2012
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 4 years or older at time of consent, may be male or female.
- Meet the Hanifin diagnostic criteria for atopic dermatitis.
- Capable of giving informed consent (for patients less than 18 years of age, assent will be obtained from the minor and informed consent will be obtained from a legal guardian).
- Able to image their skin or have someone do it for them.
- Able to adhere to the study visit schedule and other protocol requirements.
- Have access to a computer with internet connection, a digital camera, and an e-mail address.
Who cannot join
- Non English speaking patients.
- Patients requiring systemic treatment (e.g., cyclosporine, phototherapy).
- Patients requiring close laboratory monitoring.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Comparison Between Asynchronous Online Care Model for the Management of Atopic Dermatitis With That of Face-to-Face, Office Visits
The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of atopic dermatitis. The investigators also aim to determine the effects of this online care model on patient quality of life as well as patient and physician satisfaction.
The investigators' hypotheses include the following:
- Compared to in-person visits, the online care model will result in similar clinical improvement in atopic dermatitis disease severity.
- Compared to in-person visits, the online care model will result in similar improvements in quality of life.
- Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.
- Conditions
- Atopic Dermatitis
- Being tested
- Online Teledermatology Care, Conventional in Office Care
- Keywords
- Teledermatology, Telemedicine, Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Teledermatology CareOther
Also called Health care service modality
Patients randomized to the intervention group will have their scheduled follow-up visits online via store and forward teledermatology.
Conventional in Office CareOther
Also called Health care service modality
Patients randomized to the control group will have their scheduled follow-up visits via conventional in office care.
| Study group | Role | What they receive |
|---|---|---|
| Teledermatology | Experimental | Online Telemedicine Group Receives: Other: Online Teledermatology Care |
| Usual Care | Active comparator | Conventional in-office care Receives: Other: Conventional in Office Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
Measured: Every 8 weeks
Patient-oriented Eczema Measure (POEM)
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April W Armstrong, MD, Principal investigator, UC Davis Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985894
- Sponsor's protocol ID
- 200917162
- Status last verified
- May 2017
- First submitted
- 25 Sep 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Armstrong AW, Johnson MA, Lin S, Maverakis E, Fazel N, Liu FT. Patient-centered, direct-access online care for management of atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):154-60. doi: 10.1001/jamadermatol.2014.2299.
PubMed 25338198
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Asynchronous Online Care Model for the Management of Atopic Dermatitis With That of Face-to-Face, Office Visits
- ClinicalTrials.gov ID
- NCT00985894
- Acronym / sponsor ID
- 200917162
- Conditions
- Atopic Dermatitis
- Keywords
- Teledermatology, Telemedicine, Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Sep 2009 (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.
The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of atopic dermatitis. The investigators also aim to determine the effects of this online care model on patient quality of life as well as patient and physician satisfaction.
The investigators' hypotheses include the following:
- Compared to in-person visits, the online care model will result in similar clinical improvement in atopic dermatitis disease severity.
- Compared to in-person visits, the online care model will result in similar improvements in quality of life.
- Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teledermatology | Experimental | Other: Online Teledermatology CareOnline Telemedicine Group |
| Usual Care | Active comparator | Other: Conventional in Office CareConventional in-office care |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 4 years or older at time of consent, may be male or female.
- Meet the Hanifin diagnostic criteria for atopic dermatitis.
- Capable of giving informed consent (for patients less than 18 years of age, assent will be obtained from the minor and informed consent will be obtained from a legal guardian).
- Able to image their skin or have someone do it for them.
- Able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (3 listed)
- Non English speaking patients.
- Patients requiring systemic treatment (e.g., cyclosporine, phototherapy).
- Patients requiring close laboratory monitoring.
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 |
|---|---|---|
| Online Teledermatology CareAlso: Health care service modalityPatients randomized to the intervention group will have their scheduled follow-up visits online via store and forward teledermatology. | Other | Teledermatology |
| Conventional in Office CareAlso: Health care service modalityPatients randomized to the control group will have their scheduled follow-up visits via conventional in office care. | Other | Usual Care |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: Every 8 weeks
Patient-oriented Eczema Measure (POEM)
Time frame: Every 8 weeks
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 30 May 2017.
- Derived from this study: PubMed 25338198Armstrong AW, Johnson MA, Lin S, Maverakis E, Fazel N, Liu FT. Patient-centered, direct-access online care for management of atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):154-60. doi: 10.1001/jamadermatol.2014.2299.
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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.
April W Armstrong, MD principal investigator
UC Davis Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Teledermatology Care and Conventional in Office Care in people with Atopic Dermatitis, run by University of California, Davis 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 6 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: finished, as of the sponsor's last update on 30 May 2017. 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.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: Every 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985894, which also lists 1 linked publication.
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 30 May 2017.