Website Application Based Education and Text Messaging in Improving Skin Wound Care in Patients Undergoing Mohs Surgery

Malignant Skin Neoplasm Clinical Trial

Official title:

Web App Based Patient Education in Mohs Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373722
• Other study ID #: IRB00028840
• Secondary ID: NCI-2015-00217CC
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

III. The rate of adverse events.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP I: 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 twice daily (BID) to the wound area.

GROUP II: 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.

GROUP III: 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.

GROUP IV: 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.

After completion of study, patients are followed up at 1 week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Skin Neoplasm
• Skin Neoplasms

Intervention

Procedure:
• Mohs Surgery
Undergo Mohs surgery

Other:
• Internet-Based Intervention
Watch website application based educational video

Behavioral:
• Telephone-Based Intervention
Receive text messages

Other:
• Educational Intervention
Watch website application based educational video

Behavioral:
• Exercise Intervention
Use Fitbit

Other:
• Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Applied to the wound area
• Questionnaire Administration
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative anxiety score	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.	Before surgery
Primary	Patient knowledge score	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.	Up to 1 week after completion of study
Primary	Medication adherence	The mean number of times the medication was applied will be compared for the three intervention groups versus the control group.	Up to 1 week after completion of study
Secondary	Patient satisfaction score	Patient satisfaction scores across the four randomization groups will be compared using analysis of variance (ANOVA) methods.	Up to 1 week after completion of study
Secondary	Mobility adherence as measured by Fitbit monitor	Compare the average number of steps taken each day between groups and the cumulative number of steps taken over the whole week using ANOVA methods. Percentage of patients with average daily activity below 2500 steps will be compared using the Chi-Squared or Fisher's Exact test. All three intervention groups will be compared to the control group.	Up to 1 week after completion of study
Secondary	Incidence of adverse events	The proportion of patients reporting adverse events will be compared using chi-squared tests or Fisher's exact tests, depending on the expected frequency of events. Comparisons will be made for those given versus not given the surgery education mobile app and then for those given versus not given text messages. To look at all four groups independently, a global statistic will be initially calculated. If significant, comparisons between the four groups will be made.	Up to 1 week after completion of study