Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
128 participants
INTERVENTIONAL
2000-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Wheelchair In-Seat Activity Tracker
NCT04168450
Medical Telemonitoring Plus Individual Teleconsultation in Elderly
NCT02196428
An Evaluation of Home-Based Telemedicine Services
NCT00105846
Improving Diabetes Care Via Telephone Assessment and Patient Education
NCT00012649
Evidence-Based Tele-Emergency Network Grant Program
NCT02877810
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Web-based telemedicine system for assessment of status of pressure ulcers
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Web-based telemedicine system for assessment of status of pressure ulcers
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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:
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julie C Lowery, PhD MHSA
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kim HM, Lowery JC, Hamill JB, Wilkins EG. Accuracy of a web-based system for monitoring chronic wounds. Telemed J E Health. 2003 Summer;9(2):129-40. doi: 10.1089/153056203766437471.
Kim HM, Lowery JC, Hamill JB, Wilkins EG. Patient attitudes toward a Web-based system for monitoring chronic wounds. Telemed J E Health. 2004;10 Suppl 2:S-26-34.
Lowery JC, Hamill JB, Wilkins EG, Clements E. Technical overview of a web-based telemedicine system for wound assessment. Adv Skin Wound Care. 2002 Jul-Aug;15(4):165-6, 168-9. doi: 10.1097/00129334-200207000-00007.
Roth RS, Lowery JC, Hamill JB. Assessing persistent pain and its relation to affective distress, depressive symptoms, and pain catastrophizing in patients with chronic wounds: a pilot study. Am J Phys Med Rehabil. 2004 Nov;83(11):827-34. doi: 10.1097/01.phm.0000140800.83146.fa.
Wilkins EG, Lowery JC, Goldfarb S. Feasibility of virtual wound care: a pilot study. Adv Skin Wound Care. 2007 May;20(5):275-6, 278. doi: 10.1097/01.ASW.0000269315.30639.82.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACC 97-013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.