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Clinical Trials/NCT02373722
NCT02373722CompletedNot Applicable

Web App Based Patient Education in Mohs Surgery

Wake Forest University Health Sciences2 sites in 1 country90 target enrollmentStarted: March 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
2
Primary Endpoint
Patient knowledge score

Study Overview

Brief Summary

This randomized clinical trial studies how well website application (web app) based education and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a surgical procedure used to treat skin cancer). Website application and text messaging based education may help patients stick to wound care instructions before and after surgery, lower anxiety level, and may help monitor their activity.

Detailed Description

PRIMARY OBJECTIVES:

I. To create a web application which will educate dermatologic surgery patients prior to their operations with educational videos.

SECONDARY OBJECTIVES:

I. To create and evaluate a web based system to send wound care instructions to patients by text message after their operation.

II. Qualitative comments from participants and research staff concerning the feasibility of this approach and the use of Fitbit activity trackers as a means to monitor movement restriction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The patient is undergoing Mohs surgery
  • Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
  • The subject is able to complete the study and comply with study instructions, including attending all study visits
  • The patient has a cell phone capable of receiving text messages

Exclusion Criteria

  • The patient is not indicated for Mohs surgery
  • Inability to complete all study-related visits
  • Non-English speaking patients
  • The patient cannot receive text messages

Arms & Interventions

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Mohs Surgery (Procedure)

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Internet-Based Intervention (Other)

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Telephone-Based Intervention (Behavioral)

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Educational Intervention (Other)

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Exercise Intervention (Behavioral)

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment (Other)

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Questionnaire Administration (Other)

Group I (video, text message)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Intervention: Survey Administration (Other)

Group II (educational video)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Intervention: Mohs Surgery (Procedure)

Group II (educational video)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Intervention: Internet-Based Intervention (Other)

Group II (educational video)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Intervention: Educational Intervention (Other)

Group II (educational video)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Intervention: Exercise Intervention (Behavioral)

Group II (educational video)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Intervention: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment (Other)

Group II (educational video)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Intervention: Questionnaire Administration (Other)

Group II (educational video)

Experimental

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Intervention: Survey Administration (Other)

Group III (text message)

Experimental

Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

Intervention: Mohs Surgery (Procedure)

Group III (text message)

Experimental

Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

Intervention: Telephone-Based Intervention (Behavioral)

Group III (text message)

Experimental

Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

Intervention: Exercise Intervention (Behavioral)

Group III (text message)

Experimental

Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

Intervention: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment (Other)

Group III (text message)

Experimental

Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

Intervention: Questionnaire Administration (Other)

Group III (text message)

Experimental

Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

Intervention: Survey Administration (Other)

Group IV (control)

Experimental

Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.

Intervention: Mohs Surgery (Procedure)

Group IV (control)

Experimental

Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.

Intervention: Exercise Intervention (Behavioral)

Group IV (control)

Experimental

Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.

Intervention: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment (Other)

Group IV (control)

Experimental

Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.

Intervention: Questionnaire Administration (Other)

Group IV (control)

Experimental

Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.

Intervention: Survey Administration (Other)

Outcomes

Primary Outcomes

Patient knowledge score

Time Frame: Up to 1 week after completion of study

Patient knowledge scores of patients randomized to receive or not receive the educational video will be compared using a t-test or appropriate non-parametric test (Wilcoxon Rank Sum or Sign test) based on the distribution of the scores.

Medication adherence

Time Frame: Up to 1 week after completion of study

The mean number of times the medication was applied will be compared for the three intervention groups versus the control group.

Preoperative anxiety score

Time Frame: Before surgery

The preoperative anxiety scores of patients randomized to receive or not receive the educational video will be compared using a t-test or appropriate non-parametric test (Wilcoxon Rank Sum or Sign test) based on the distribution of the scores.

Secondary Outcomes

  • Mobility adherence as measured by Fitbit monitor(Up to 1 week after completion of study)
  • Incidence of adverse events(Up to 1 week after completion of study)
  • Patient satisfaction score(Up to 1 week after completion of study)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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