- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00012597
Pressure Ulcer Assessment Via Telemedicine
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Georgia
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Decatur, Georgia, Stati Uniti, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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:
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Braccio 1
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Julie C Lowery, PhD MHSA, VA Ann Arbor Healthcare System, Ann Arbor, MI
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ACC 97-013
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .