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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
Chan-Yeong Heo
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 3, 2015
Last Updated
March 10, 2015
Sponsor
Chan-Yeong Heo
Collaborators
KT Corporation
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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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