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Trial record 41 of 661 for:    applied AND web-

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

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ClinicalTrials.gov Identifier: NCT02373722
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Malignant Skin Neoplasm Procedure: Mohs Surgery Other: Internet-Based Intervention Behavioral: Telephone-Based Intervention Other: Educational Intervention Behavioral: Exercise Intervention Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment Other: Questionnaire Administration Other: Survey Administration Not Applicable

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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Web App Based Patient Education in Mohs Surgery
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Skin Cancer
Drug Information available for: Petrolatum

Arm Intervention/treatment
Experimental: Group I (video, text message)
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.
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
Other Names:
  • Education for Intervention
  • Intervention, Educational

Behavioral: Exercise Intervention
Use Fitbit

Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Applied to the wound area
Other Name: Aquaphor

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Experimental: Group II (educational video)
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
Procedure: Mohs Surgery
Undergo Mohs surgery

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

Other: Educational Intervention
Watch website application based educational video
Other Names:
  • Education for Intervention
  • Intervention, Educational

Behavioral: Exercise Intervention
Use Fitbit

Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Applied to the wound area
Other Name: Aquaphor

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Experimental: Group III (text message)
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.
Procedure: Mohs Surgery
Undergo Mohs surgery

Behavioral: Telephone-Based Intervention
Receive text messages

Behavioral: Exercise Intervention
Use Fitbit

Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Applied to the wound area
Other Name: Aquaphor

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Experimental: Group IV (control)
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.
Procedure: Mohs Surgery
Undergo Mohs surgery

Behavioral: Exercise Intervention
Use Fitbit

Other: Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment
Applied to the wound area
Other Name: Aquaphor

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02373722


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Daniel Pearce Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02373722     History of Changes
Other Study ID Numbers: IRB00028840
NCI-2015-00217 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 01714 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Petrolatum
Mineral Oil
Emollients
Dermatologic Agents