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临床试验/NCT02373722
NCT02373722已完成不适用

Web App Based Patient Education in Mohs Surgery

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Patient knowledge score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: 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

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: Survey Administration (Other)

结局指标

主要结局

Patient knowledge score

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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