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Completed

NCT Number: NCT02373722

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

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.

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Key information

Conditions

Malignant Skin Neoplasm Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mohs surgery

Procedure

Undergo Mohs surgery

Internet-Based Intervention

Other

Watch website application based educational video

Telephone-Based Intervention

Behavioral

Receive text messages

Educational Intervention

Other

Watch website application based educational video

Other names: Education for Intervention, Intervention, Educational

Exercise Intervention

Behavioral

Use Fitbit

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Other

Applied to the wound area

Other names: Aquaphor

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Patient satisfaction score

    Time frame: Up to 1 week after completion of study

    Patient satisfaction scores across the four randomization groups will be compared using analysis of variance (ANOVA) methods.

  2. Mobility adherence as measured by Fitbit monitor

    Time frame: Up to 1 week after completion of study

    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.

  3. Incidence of adverse events

    Time frame: Up to 1 week after completion of study

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Web App Based Patient Education in Mohs Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2015
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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