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Video-Based Education for Dermatology Patients on Systemic Corticosteroids

Primary Purpose

Chronic Inflammatory Skin Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
Standard Script
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Inflammatory Skin Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Emory Dermatology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Video

Standard script

Arm Description

An educational video discussing the benefits and risk associated with long term usage of systemic corticosteroids.

Standard scripted discussion of risks and benefits of systemic corticosteroids read to participants.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2013
Last Updated
March 5, 2015
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01991236
Brief Title
Video-Based Education for Dermatology Patients on Systemic Corticosteroids
Official Title
The Efficiency and Effectiveness of Video-Based Education for Dermatology Patients Qualifying for Chronic Treatment With Systemic Corticosteroids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Skin Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video
Arm Type
Experimental
Arm Description
An educational video discussing the benefits and risk associated with long term usage of systemic corticosteroids.
Arm Title
Standard script
Arm Type
Other
Arm Description
Standard scripted discussion of risks and benefits of systemic corticosteroids read to participants.
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
Educational video discussing risks and benefits of chronic use of systemic corticosteroids.
Intervention Type
Behavioral
Intervention Name(s)
Standard Script
Intervention Description
Standard scripted discussion of risks and benefits of chronic corticosteroid usage read to patients.
Primary Outcome Measure Information:
Title
Change in patient knowledge of systemic corticosteroids
Description
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.
Time Frame
Up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin K Stoff, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Dermatology Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States

12. IPD Sharing Statement

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Video-Based Education for Dermatology Patients on Systemic Corticosteroids

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