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Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telemedicine system
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

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects who have pressure ulcer
  • Subjects who voluntarily decided the participation of the study and signed the informed consent

Exclusion Criteria:

  • Subjects who have Osteomyelitis
  • Subjects who have suppuration
  • Subjects 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

Experimental

Arm Label

Telemedicine system

Arm Description

Telemedicine system

Outcomes

Primary Outcome Measures

Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.

Secondary Outcome Measures

Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.

Full Information

First Posted
February 17, 2015
Last Updated
March 2, 2015
Sponsor
Chan-Yeong Heo
Collaborators
KT Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02382302
Brief Title
Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management
Official Title
A Smart Phone-based Tele-consultation System in the Management of Chronic Pressure Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (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
This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.
Detailed Description
This trial conducted to assess the efficiency of teleconsultation using the smart-phone-based store-and-forward system in promoting the wound healing process as well as cost-effectiveness in patients with pressure ulcer.

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

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
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine system
Arm Type
Experimental
Arm Description
Telemedicine system
Intervention Type
Device
Intervention Name(s)
Telemedicine system
Intervention Description
The data such as photographs can be collected simply using built-in cameras installed in smart-phones that used the standard touch-screen user interface (UI) and camera installed in the iPhone3GS and iPhone4 using iOS 3.0 and iOS 5.0, respectively. Subjects were instructed to transmit the photographs of the wounds then investigator performed the photography in such a manner that the size of pressure ulcer should be automatically measured based on a 1 cm x 1 cm-sized indicator on the screen.
Primary Outcome Measure Information:
Title
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Description
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
Time Frame
4weeks post-treatment
Secondary Outcome Measure Information:
Title
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Description
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
Time Frame
1week post-treatment
Title
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Description
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
Time Frame
2weeks post-treatment
Title
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Description
Data collection The measurement of the size of pressure ulcer Medical examination;the degree of recovery of pressure ulcer Remote physician monitoring - The patient data was transmitted from the smart-phone to the website via open application programming interface (API) Prescription Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
Time Frame
3weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have pressure ulcer Subjects who voluntarily decided the participation of the study and signed the informed consent Exclusion Criteria: Subjects who have Osteomyelitis Subjects who have suppuration Subjects 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

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Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management

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