Mobile Devices as Educational Skin History Tools
Primary Purpose
Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile app
Sponsored by
About this trial
This is an interventional supportive care trial for Skin Cancer
Eligibility Criteria
Inclusion Criteria:
- Have an appointment in the Penn Dermatologic Surgery Clinic for removal of a skin area during the study enrollment period
- Possession of a mobile device running iOS with the study mobile app (intervention) successfully installed (assistance will be provided by research staff if needed)
Exclusion Criteria:
- Children or adolescents, or if the patient is court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
- Patients will also be excluded if they are incompetent to provide informed consent and HIPAA authorization.
- If the area being operated on is of the genitals or breasts
- If the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufficiently such that photos are non-identifying
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control - Standard of Care
Intervention - Mobile app
Arm Description
The standard of care consists of in-clinic counseling, informational handouts, and access to patient medical records
The mobile app, or app, is used to document before and after photos of the excised skin areas and to document related diagnoses. The app allows patients to view a skin history summary report and a reference on their skin findings and procedures.
Outcomes
Primary Outcome Measures
Understanding of recent skin excision - 3 weeks later
After study enrollment, patients have one or more skin areas excised. They complete an in-clinic survey immediately after the excision and another survey 3 weeks later where they are asked questions regarding the clinic visit and the related excised skin areas and diagnoses. Understanding is assessed by comparing against the medical record to calculate the number/percent of correct responses.
Secondary Outcome Measures
Full Information
NCT ID
NCT03419637
First Posted
January 26, 2018
Last Updated
June 28, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03419637
Brief Title
Mobile Devices as Educational Skin History Tools
Official Title
Evaluating the Use of Mobile Devices as Educational Tools Regarding Skin History
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
August 2, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Part I of this study surveys patients in the Penn Dermatologic Surgery Clinic to evaluate if a need exists for increased patient understanding of their skin history and which factors, if any, related to the patient or their skin history are associated with this need. In part II, the study aim is to evaluate mobile technology as a way of improving patient understanding of diagnoses, treatments, and procedures. In this part of the study, eligible patients from part I will be randomized either to a control group that receives the current standard of care regarding in-clinic counseling, informational handouts, and access to their medical records, or to an intervention group that in addition to the current standard of care, is setup with a mobile app, allowing patients to view a skin history summary report and a reference on their skin findings and procedures. Patients then complete a survey to establish their baseline understanding of their clinic visit. Three weeks later the patient is emailed a follow-up survey to assess their understanding of their in-clinic visit. Differences in understanding between the two study groups will be assessed by comparing the number of correctly answered survey items regarding their in-clinic visit, both at baseline (immediately following their surgery) and three weeks later. Qualitative information regarding satisfaction and areas of improvement will also be collected via survey. Patients who have an appointment during the study period at the Penn Dermatologic Surgery clinic for a skin excision will be eligible for inclusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - Standard of Care
Arm Type
No Intervention
Arm Description
The standard of care consists of in-clinic counseling, informational handouts, and access to patient medical records
Arm Title
Intervention - Mobile app
Arm Type
Experimental
Arm Description
The mobile app, or app, is used to document before and after photos of the excised skin areas and to document related diagnoses. The app allows patients to view a skin history summary report and a reference on their skin findings and procedures.
Intervention Type
Other
Intervention Name(s)
Mobile app
Intervention Description
The mobile app, or app, is installed on the patient's mobile device and is used to document the surgical procedure with before and after photographs, including pre- and post-surgery diagnosis. The app allows patients to view a skin history summary report and a reference on their skin findings and procedures.
Primary Outcome Measure Information:
Title
Understanding of recent skin excision - 3 weeks later
Description
After study enrollment, patients have one or more skin areas excised. They complete an in-clinic survey immediately after the excision and another survey 3 weeks later where they are asked questions regarding the clinic visit and the related excised skin areas and diagnoses. Understanding is assessed by comparing against the medical record to calculate the number/percent of correct responses.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have an appointment in the Penn Dermatologic Surgery Clinic for removal of a skin area during the study enrollment period
Possession of a mobile device running iOS with the study mobile app (intervention) successfully installed (assistance will be provided by research staff if needed)
Exclusion Criteria:
Children or adolescents, or if the patient is court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
Patients will also be excluded if they are incompetent to provide informed consent and HIPAA authorization.
If the area being operated on is of the genitals or breasts
If the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufficiently such that photos are non-identifying
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Miller, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Devices as Educational Skin History Tools
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