Pressure Ulcer Assessment Via Telemedicine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012597
First received: March 14, 2001
Last updated: April 14, 2014
Last verified: April 2014

March 14, 2001
April 14, 2014
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Complete list of historical versions of study NCT00012597 on ClinicalTrials.gov Archive Site
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Pressure Ulcer Assessment Via Telemedicine
Pressure Ulcer Assessment Via Telemedicine

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 (i.e., 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 AHCPR's Clinical Practice Guideline, Treatment of Pressure Ulcers.

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 (i.e., 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 AHCPR's 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 yes/no responses to four diagnostic questions concerning wound healing and infection, based on AHCPR guidelines, and they were blinded to each other�s 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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pressure Ulcers
Procedure: Web-based telemedicine system for assessment of status of pressure ulcers
Arm 1
Intervention: Procedure: Web-based telemedicine system for assessment of status of pressure ulcers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
September 2000
Not Provided

Inclusion Criteria:

VA inpatients, outpatients, or nursing home residents at the participating sites who have any of the following wounds: (1) chronic pressure ulcers at stage II, III or IV; (2) post-operative wound patients having undergone a skin flap procedure for a grade III or IV pressure ulcer; (3) diabetic wounds; (4) arterial ulcers; or (5) chronic venous status ulcers. Exclusion criteria: Mentally incompetent patients.

Exclusion Criteria:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012597
ACC 97-013
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Julie C Lowery, PhD MHSA VA Ann Arbor Healthcare System
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP