Chronic Inflammatory Skin DiseasesNCT01991236
Video-Based Education for Dermatology Patients on Systemic Corticosteroids
A study testing Video and Standard Script in people with Chronic Inflammatory Skin Diseases, run by Emory University at 1 site in United States.
Trial summary
1.0 Title: "The Efficiency and Effectiveness of Video-Based Education for Dermatology Patients Qualifying for Chronic Treatment with Systemic Corticosteroids" 2.0 Background: Past studies have shown that the use of educational videos has been effective in increasing patient education and satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Skin Diseases
- What is being tested?
- Video and Standard Script
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase I and Phase II: All patients who arrive at the Emory Dermatology Department Clinic during a participating study physician's clinic day who are over the age 18 and speak and read English. Phase III: All patients who require treatment with long term oral corticosteroids (>6 weeks) as determined by their treatment physicians, who are non-pregnant, over the age of 18, and speak and read English.
Who cannot join
- Phase I and Phase II: Patients under age 18, or who do not speak or read English. Phase III Patients who are immunosuppressed, who are pregnant, who are under the age of 18, who have been treated with steroids by a participating study physician in the past, who require corticosteroid treatment <6 weeks, or who do not speak or read English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficiency and Effectiveness of Video-Based Education for Dermatology Patients Qualifying for Chronic Treatment With Systemic Corticosteroids
1.0 Title: "The Efficiency and Effectiveness of Video-Based Education for Dermatology Patients Qualifying for Chronic Treatment with Systemic Corticosteroids"
2.0 Background: Past studies have shown that the use of educational videos has been effective in increasing patient education and satisfaction. These studies suggest that such video tools may enable an office to be significantly more efficient.
Read more
3.0 Objective: The Emory University Department of Dermatology has created an educational video as part of clinical care. The objective for Phase I of the study is to collect information about dermatology patients' baseline knowledge about corticosteroid and/or corticosteroid sparing medication treatment using an online (or written copy) questionnaire. The objective for Phase II of the study is to determine the effect of a video on dermatology patient knowledge. The objective for Phase III of the study is to determine the office efficiency of the video in patients requiring long-term oral corticosteroid and/or corticosteroid sparing medications. Secondary objectives of the study are to determine patient and physician satisfaction with the video as an educational tool.
4.0 Patient Selection: Phase I and Phase II: Patients who arrive to clinic during a participating physician's clinic day at the Emory Dermatology Department. Phase III: Patients who require treatment with long term oral corticosteroids at the Emory University Department of Dermatology Clinic as determined by their treatment physician.
5.0 Recruitment: All patients arriving to clinic on a study day will be given an informational opt-out sheet. All patients will be eligible to complete Phase I and Phase II: (steroid questionnaire only and steroid video or verbal education plus questionnaires). Only patients who require long term oral corticosteroid treatment will proceed to Phase III: of the study. Physicians will be recruited from the Emory Dermatology Department.
6.0 Assessment: Patients in Phase I will complete to the pre-education questionnaire online (or a written copy). Their results will be compared with baseline results from patients in Phase III: who undergo treatment with steroids. Patients in Phase II or III will be randomized to two groups. Control patients will receive verbal discussion of corticosteroid treatment. Phase II control patient education will be using a script developed by study physicians and delivered by study personnel. Phase III patients who qualify for long term systemic steroid will have verbal education by their doctor as usual. Video patients will receive an educational video instead, and will write down any remaining questions after viewing for their doctor to address as soon as possible. After verbal or video education, both groups will take a post-education questionnaire and patient satisfaction surveys online. Phase II is then complete. In Phase III, both groups will follow-up at least 1, 3, and 6 months after beginning treatment. At follow-up, their doctor will ask about current corticosteroid dose and frequency, willingness to transition to a steroid-sparing method, and compliance with preventative measures during treatment. Patients will complete the same post-education questionnaire online again at these visits. Physicians will also complete satisfaction surveys online at 1, 3, and 6 months from study start, and then every 6 months.
6.1 Sample size: The sample size for Phase I is unlimited until the last Phase II patient completes enrollment. Emory plans to recruit a total of 80 patients to participate in Phase II of this study (40 per group).
6.2 Participant time burden: Phase I only: 5-10 minutes Phase II and III: 30-35 minutes Physicians: 20 minutes
- Conditions
- Chronic Inflammatory Skin Diseases
- Being tested
- Video, Standard Script
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
Educational video discussing risks and benefits of chronic use of systemic corticosteroids.
Standard ScriptBehavioural
Standard scripted discussion of risks and benefits of chronic corticosteroid usage read to patients.
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | An educational video discussing the benefits and risk associated with long term usage of systemic corticosteroids. Receives: Behavioral: Video |
| Standard script | Other | Standard scripted discussion of risks and benefits of systemic corticosteroids read to participants. Receives: Behavioral: Standard Script |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient knowledge of systemic corticosteroids
To determine the effect of the video intervention on patient knowledge assessed with a one-time post-educational questionnaire in comparison to a scripted verbal education method among dermatology patients coming to a complex medical dermatology clinic.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Stoff, Emory University
- Investigators
- Benjamin K Stoff, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991236
- Sponsor's protocol ID
- IRB00059584
- Status last verified
- Mar 2015
- First submitted
- 5 Nov 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Effectiveness of Video-Based Education for Dermatology Patients Qualifying for Chronic Treatment With Systemic Corticosteroids
- ClinicalTrials.gov ID
- NCT01991236
- Acronym / sponsor ID
- IRB00059584
- Conditions
- Chronic Inflammatory Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Nov 2013 (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.
1.0 Title: "The Efficiency and Effectiveness of Video-Based Education for Dermatology Patients Qualifying for Chronic Treatment with Systemic Corticosteroids"
2.0 Background: Past studies have shown that the use of educational videos has been effective in increasing patient education and satisfaction. These studies suggest that such video tools may enable an office to be significantly more efficient.
3.0 Objective: The Emory University Department of Dermatology has created an educational video as part of clinical care. The objective for Phase I of the study is to collect information about dermatology patients' baseline knowledge about corticosteroid and/or corticosteroid sparing medication treatment using an online (or written copy) questionnaire. The objective for Phase II of the study is to determine the effect of a video on dermatology patient knowledge. The objective for Phase III of the study is to determine the office efficiency of the video in patients requiring long-term oral corticosteroid and/or corticosteroid sparing medications. Secondary objectives of the study are to determine patient and physician satisfaction with the video as an educational tool.
4.0 Patient Selection: Phase I and Phase II: Patients who arrive to clinic during a participating physician's clinic day at the Emory Dermatology Department. Phase III: Patients who require treatment with long term oral corticosteroids at the Emory University Department of Dermatology Clinic as determined by their treatment physician.
5.0 Recruitment: All patients arriving to clinic on a study day will be given an informational opt-out sheet. All patients will be eligible to complete Phase I and Phase II: (steroid questionnaire only and steroid video or verbal education plus questionnaires). Only patients who require long term oral corticosteroid treatment will proceed to Phase III: of the study. Physicians will be recruited from the Emory Dermatology Department.
6.0 Assessment: Patients in Phase I will complete to the pre-education questionnaire online (or a written copy). Their results will be compared with baseline results from patients in Phase III: who undergo treatment with steroids. Patients in Phase II or III will be randomized to two groups. Control patients will receive verbal discussion of corticosteroid treatment. Phase II control patient education will be using a script developed by study physicians and delivered by study personnel. Phase III patients who qualify for long term systemic steroid will have verbal education by their doctor as usual. Video patients will receive an educational video instead, and will write down any remaining questions after viewing for their doctor to address as soon as possible. After verbal or video education, both groups will take a post-education questionnaire and patient satisfaction surveys online. Phase II is then complete. In Phase III, both groups will follow-up at least 1, 3, and 6 months after beginning treatment. At follow-up, their doctor will ask about current corticosteroid dose and frequency, willingness to transition to a steroid-sparing method, and compliance with preventative measures during treatment. Patients will complete the same post-education questionnaire online again at these visits. Physicians will also complete satisfaction surveys online at 1, 3, and 6 months from study start, and then every 6 months.
6.1 Sample size: The sample size for Phase I is unlimited until the last Phase II patient completes enrollment. Emory plans to recruit a total of 80 patients to participate in Phase II of this study (40 per group).
6.2 Participant time burden: Phase I only: 5-10 minutes Phase II and III: 30-35 minutes Physicians: 20 minutes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Behavioral: VideoAn educational video discussing the benefits and risk associated with long term usage of systemic corticosteroids. |
| Standard script | Other | Behavioral: Standard ScriptStandard scripted discussion of risks and benefits of systemic corticosteroids read to participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Phase I and Phase II: All patients who arrive at the Emory Dermatology Department Clinic during a participating study physician's clinic day who are over the age 18 and speak and read English. Phase III: All patients who require treatment with long term oral corticosteroids (>6 weeks) as determined by their treatment physicians, who are non-pregnant, over the age of 18, and speak and read English.
Key exclusion criteria (1 listed)
- Phase I and Phase II: Patients under age 18, or who do not speak or read English. Phase III Patients who are immunosuppressed, who are pregnant, who are under the age of 18, who have been treated with steroids by a participating study physician in the past, who require corticosteroid treatment <6 weeks, or who do not speak or read English.
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 |
|---|---|---|
| VideoEducational video discussing risks and benefits of chronic use of systemic corticosteroids. | Behavioural | Video |
| Standard ScriptStandard scripted discussion of risks and benefits of chronic corticosteroid usage read to patients. | Behavioural | Standard script |
Primary outcome
Change in patient knowledge of systemic corticosteroids
Time frame: Up to six months
To determine the effect of the video intervention on patient knowledge assessed with a one-time post-educational questionnaire in comparison to a scripted verbal education method among dermatology patients coming to a complex medical dermatology clinic.
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 6 Mar 2015.
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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.
Benjamin K Stoff, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Standard Script in people with Chronic Inflammatory Skin Diseases, run by Emory University 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 1 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 6 Mar 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.
What does the primary outcome measure?
Change in patient knowledge of systemic corticosteroids (time frame: Up to six months). 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 6 Mar 2015.