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Tracking Information | |||||
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First Received Date † | March 14, 2001 | ||||
Last Updated Date | January 30, 2009 | ||||
Start Date † | |||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00012597 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Pressure Ulcer Assessment Via Telemedicine | ||||
Official Title † | Pressure Ulcer Assessment Via Telemedicine | ||||
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 (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.� |
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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 (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 |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † | Pressure Ulcers | ||||
Intervention † | Procedure: Web-based telemedicine system for assessment of status of pressure ulcers | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 128 | ||||
Completion Date | September 2000 | ||||
Primary Completion Date | |||||
Eligibility 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. Exclusion Criteria: |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00012597 | ||||
Responsible Party | Lowery, Julie - Principal Investigator, Department of Veterans Affairs | ||||
Secondary IDs †† | |||||
Study Sponsor † | Department of Veterans Affairs | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Department of Veterans Affairs | ||||
Verification Date | March 2001 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |