Telemedicine |
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Clinical Trial: Pressure Ulcer Assessment via Telemedicine
This study has been completed.
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Purpose
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. 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. 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.
| Condition | Treatment or Intervention |
|---|---|
| Pressure Ulcers | Procedure: Web-based telemedicine system for assessment of status of pressure ulcers |
MedlinePlus related topics: Pressure Sores
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Expected Total Enrollment: 128
Study start: October 1998; Study completion: September 2000
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Location Information
Georgia
Atlanta VA Medical Center, Decatur, Georgia, 30033, United States
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, Michigan, 48113-0170, United States
VA Ann Arbor Healthcare System, Ann Arbor, Michigan, 48113-0170, United States
More Information
Record last reviewed: November 2000
Last Updated: October 13, 2004
Record first received: March 14, 2001
ClinicalTrials.gov Identifier: NCT00012597
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Centers of Excellence - Telemedicine in the National Centers of Excellence in Women's Health (National Women's Health Information Center, OWH, HHS)
- Telemedicine (National Women's Health Information Center)

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