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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00012597 |
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.�
Condition | Intervention |
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Pressure Ulcers |
Procedure: Web-based telemedicine system for assessment of status of pressure ulcers |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Pressure Ulcer Assessment Via Telemedicine |
Estimated Enrollment: | 128 |
Study Completion Date: | September 2000 |
Arms | Assigned Interventions |
---|---|
1 | Procedure: Web-based telemedicine system for assessment of status 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:
Ongoing
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
United States, Georgia | |
Atlanta VA Medical Center | |
Decatur, Georgia, United States, 30033 | |
United States, Michigan | |
VA Ann Arbor Healthcare System | |
Ann Arbor, Michigan, United States, 48113-0170 |
Principal Investigator: | Julie C. Lowery, PhD MHSA | VA Ann Arbor Healthcare System |
Responsible Party: | Department of Veterans Affairs ( Lowery, Julie - Principal Investigator ) |
Study ID Numbers: | ACC 97-013 |
Study First Received: | March 14, 2001 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00012597 History of Changes |
Health Authority: | United States: Federal Government |
Skin Diseases Ulcer Skin Ulcer Pressure Ulcer |
Pathologic Processes Skin Diseases Ulcer Skin Ulcer Pressure Ulcer |