Thromb Haemost 2007; 98(04): 889-895
DOI: 10.1160/TH07-02-0143
New Technologies, Diagnostic Tools and Drugs
Schattauer GmbH

ProTime self-management yielding improvement of fluency and quality of life

Heinz Völler
1   Klinik Am See, Rüdersdorf, Germany
,
Uwe Taborski
2   Gesellschaft für Humanplasma, Bad Nauheim, Germany
,
Clemens Dovifat
1   Klinik Am See, Rüdersdorf, Germany
,
Ines Hartwig
3   MtBASA, Berlin, Germany
,
Janos G. Kadar
4   Outpatient Clinic for Coagulation Disorders, Köln – West, Köln, Germany
,
Karl Wegscheider
5   Institute for Statistics and Econometry, University of Hamburg, Hamburg, Germany
,
Marcia L. Zucker
6   Response Biomedical Corporation, Burnaby, British Columbia, Canada
,
Frank M. LaDuca
7   International Technidyne Corporation, Edison, New Jersey, USA
,
Jack Ansell
8   Boston University Medical Center, Boston, Massachusetts, USA
› Author Affiliations
Financial support: This study was funded in its entirety through a research grant from International Technidyne Corporation, Edison, NJ, USA.
Further Information

Publication History

Received 24 February 2007

Accepted after resubmission 28 June 2007

Publication Date:
01 December 2017 (online)

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Summary

Patient self-management (PSM), as the standard of care for vitamin K-antagonist therapy management in Germany requires a detailed, point-of-care (POC) device-specific training program to ensure quality patient care. In a multi-center trial using the ProTime System (Training program plus POC device), 105 patients were enrolled to evaluate efficacy of training, knowledge retention, patient satisfaction and quality of life (QoL). Patients returned to the centers 1, 3 and 6 months after training to complete questionnaires and demonstrate INR test proficiency. Training assessment employed self-evaluation and comparison of POC results between PSM and professional operators. Patient satisfaction and QoL were assessed using a modification of the questionnaire described by Sawicki and the SF12v2 QoL Survey, respectively. Patients demonstrated statistically significant improvements in knowledge post training (p<0.001) and retained the acquired information (p=NS vs. post-training; N=45) after 6 months. Trained patients yielded equivalent INR results to professional operators (r=0.92) with little or no bias across all clinic visits. Compliance with weekly testing improved from 1 to 3 months (p = 0.03), remaining at the required weekly frequency through 6 months. Average patient satisfaction improved significantly during the first month and remained constant thereafter. There was a statistically significant improvement in the Physical Component Summary of SF12 between baseline and 3/6 month assessments in all centers. In conclusion, PSM requires a comprehensive system including appropriate disease and POC device training. Such a system fosters compliance, improved knowledge about underlying disease, patient satisfaction and QoL.

Footnote:

Portions of this trial were presented on November 15, 2005 at the American Heart Association Scientific Sessions 2005 in Dallas, TX, USA.