KT(KT Corporation)-SNUBH(Seoul National University Bundang Hospital) U-health Cooperative Research
Primary Purpose
Pressure Ulcer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Smart phone
Sponsored by
About this trial
This is an interventional health services research trial for Pressure Ulcer focused on measuring u-health, chronic wound management, pressure ulcer
Eligibility Criteria
Inclusion Criteria:
- Subject who has pressure ulcer or Health care provider for wound management
Exclusion Criteria:
- Subject who have Osteomyelitis
- Subject who have suppuration
- Subject who participated in other clinical trial within 30 days from screening date
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tele-consultation system
Arm Description
compare the Live assessed wound size with the transmitted Smart phone-based wound size through Tele-consultation system
Outcomes
Primary Outcome Measures
concordance rate of wound size between live assessed wound size and transmitted wound size
Secondary Outcome Measures
concordance rate of wound size between live assessed wound size and transmitted wound size
concordance rate of wound size between live assessed wound size and transmitted wound size
concordance rate of wound size between live assessed wound size and transmitted wound size
Full Information
NCT ID
NCT02385942
First Posted
March 3, 2015
Last Updated
March 10, 2015
Sponsor
Chan-Yeong Heo
Collaborators
KT Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02385942
Brief Title
KT(KT Corporation)-SNUBH(Seoul National University Bundang Hospital) U-health Cooperative Research
Official Title
KT-SNUBH U-health Cooperative Research: Target Selection and Consumers' Intention Research for Commercialization of the Pressure Ulcer Management u-Health Solution
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chan-Yeong Heo
Collaborators
KT Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to analyse utility and compatibility of U-health solution service based on mobile for chronic wound management.
Detailed Description
In this study, 'the management of pressure ulcer' defined as procedures comprising wound assessment, wound dressing and infection control, visually evaluated the outcomes of 'the management of pressure ulcer' through the tele-consultation.
This study designed to draw service targets based on utility and compatibility of U-health solution service and to analyse whether health providers use U-health solution service.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
u-health, chronic wound management, pressure ulcer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-consultation system
Arm Type
Other
Arm Description
compare the Live assessed wound size with the transmitted Smart phone-based wound size through Tele-consultation system
Intervention Type
Device
Intervention Name(s)
Smart phone
Intervention Description
measure the Live assessed wound size and the transmitted Smart phone-based wound size
determine dressing materials using Smart phone-based tele-consultation
Primary Outcome Measure Information:
Title
concordance rate of wound size between live assessed wound size and transmitted wound size
Time Frame
a week from post treatment
Secondary Outcome Measure Information:
Title
concordance rate of wound size between live assessed wound size and transmitted wound size
Time Frame
2 weeks from post treatment
Title
concordance rate of wound size between live assessed wound size and transmitted wound size
Time Frame
3 weeks from post treatment
Title
concordance rate of wound size between live assessed wound size and transmitted wound size
Time Frame
4 weeks from post treatment
Other Pre-specified Outcome Measures:
Title
Satisfaction degree of the tele-consultation as measured by questionnaire.
Time Frame
4 weeks from post treatment
Title
Usability survey
Time Frame
4 weeks from post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject who has pressure ulcer or Health care provider for wound management
Exclusion Criteria:
Subject who have Osteomyelitis
Subject who have suppuration
Subject who participated in other clinical trial within 30 days from screening date
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanyeong Heo, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
KT(KT Corporation)-SNUBH(Seoul National University Bundang Hospital) U-health Cooperative Research
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