Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Devices as Educational Skin History Tools

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03419637
Recruitment Status : Completed
First Posted : February 2, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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

Layout table for study information
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

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419637


Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Christopher Miller, MD University of Pennsylvania

Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03419637     History of Changes
Other Study ID Numbers: 826558
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases