Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012597
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Pressure Ulcer Assessment Via Telemedicine
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Pressure Ulcer Assessment Via Telemedicine
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Web-based telemedicine system for monitoring the status of patients with pressure ulcers has been developed It consists of three major data collection components 1 digital photograph of ulcer 2 quantitative measurements of wound status ie ulcer area and volume skin elasticity and 3 other wound and patient data collected by a nurse Data are collected via laptop computer and transmitted to a central database where a computer program transforms the data into the necessary reporting format The output is posted onto a World Wide Web page for access by the consulting physician The system incorporates all data requirements for assessment recommended by AHCPRs Clinical Practice Guideline Treatment of Pressure Ulcers
Detailed Description:
Background
A Web-based telemedicine system for monitoring the status of patients with pressure ulcers has been developed It consists of three major data collection components 1 digital photograph of ulcer 2 quantitative measurements of wound status ie ulcer area and volume skin elasticity and 3 other wound and patient data collected by a nurse Data are collected via laptop computer and transmitted to a central database where a computer program transforms the data into the necessary reporting format The output is posted onto a World Wide Web page for access by the consulting physician The system incorporates all data requirements for assessment recommended by AHCPRs Clinical Practice Guideline Treatment of Pressure Ulcers
Objectives
The primary objective of this pilot study was to evaluate the clinical accuracy of a telemedicine system for assessing the status of pressure ulcers both chronic and those which have been surgically repaired The principal hypotheses were 1 use of the telemedicine system results in the same diagnoses as does in-person patient assessment and 2 patients are satisfied with the telemedicine system
Methods
Two VA medical centers and two specialties participated in the study Ann Arbor plastic surgery and Augusta plastic surgery physical medicine and rehabilitation They contributed inpatients and outpatients with a pressure ulcer of stage II III or IV over a one-year enrollment period All study patients were assessed both in-person the gold standard and with the telemedicine system The in-person and telemedicine physicians provided yesno responses to four diagnostic questions concerning wound healing and infection based on AHCPR guidelines and they were blinded to each others assessments Patient satisfaction data were collected using a specially designed self-administered questionnaire to measure perceptions regarding the burden of the telemedicine system confidence in the evaluation and absence of direct contact with a physician
Status
Completed
A Web-based telemedicine system for monitoring the status of patients with pressure ulcers has been developed It consists of three major data collection components 1 digital photograph of ulcer 2 quantitative measurements of wound status ie ulcer area and volume skin elasticity and 3 other wound and patient data collected by a nurse Data are collected via laptop computer and transmitted to a central database where a computer program transforms the data into the necessary reporting format The output is posted onto a World Wide Web page for access by the consulting physician The system incorporates all data requirements for assessment recommended by AHCPRs Clinical Practice Guideline Treatment of Pressure Ulcers
Objectives
The primary objective of this pilot study was to evaluate the clinical accuracy of a telemedicine system for assessing the status of pressure ulcers both chronic and those which have been surgically repaired The principal hypotheses were 1 use of the telemedicine system results in the same diagnoses as does in-person patient assessment and 2 patients are satisfied with the telemedicine system
Methods
Two VA medical centers and two specialties participated in the study Ann Arbor plastic surgery and Augusta plastic surgery physical medicine and rehabilitation They contributed inpatients and outpatients with a pressure ulcer of stage II III or IV over a one-year enrollment period All study patients were assessed both in-person the gold standard and with the telemedicine system The in-person and telemedicine physicians provided yesno responses to four diagnostic questions concerning wound healing and infection based on AHCPR guidelines and they were blinded to each others assessments Patient satisfaction data were collected using a specially designed self-administered questionnaire to measure perceptions regarding the burden of the telemedicine system confidence in the evaluation and absence of direct contact with a physician
Status
Completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None