Mobile Devices as Educational Skin History Tools

• ClinicalTrials.gov Identifier: NCT03419637
• Recruitment Status: Completed
• First Posted: February 5, 2018
• Last Update Posted: March 11, 2019
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

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.

Condition or disease	Intervention/treatment	Phase
Skin Cancer	Other: Mobile app	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Evaluating the Use of Mobile Devices as Educational Tools Regarding Skin History
• Actual Study Start Date: April 4, 2017
• Actual Primary Completion Date: August 2, 2017
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control - Standard of Care; The standard of care consists of in-clinic counseling, informational handouts, and access to patient medical records
Experimental: Intervention - Mobile app; 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.	Other: Mobile app; 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.

Outcome Measures

Primary Outcome Measures :

1. Understanding of recent skin excision - 3 weeks later [ Time Frame: 3 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

• Principal Investigator: Christopher Miller, MD; University of Pennsylvania

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03419637
• Other Study ID Numbers: 826558
• First Posted: February 5, 2018
• Last Update Posted: March 11, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Skin Neoplasms; Neoplasms by Site; Neoplasms; Skin Diseases