Date on Master's Thesis/Doctoral Dissertation

5-2010

Document Type

Doctoral Dissertation

Degree Name

Ph. D.

Department (Legacy)

Department of Epidemiology and Clinical Investigation Sciences

Committee Chair

Hornung, Carlton

Author's Keywords

Telemonitoring; Functional capacity; Clinically meaningful; Regression to the mean; Heart failure; Quality of life; Weight monitoring

Subject

Patient monitoring; Heart--Diseases--Patients

Abstract

Background . Heart failure treatment guidelines emphasize the importance of daily weight monitoring. To support this practice, the Health Care Financing Administration Heart Failure Demonstration Project (2000) was designed to evaluate the effect of technology driven monitoring of daily weight and symptoms in elderly HF patients (NYHA class II to IV). This sub-study is conducted to assess the effect of a technology driven HF monitoring system on clinically meaningful change in functional capacity and quality of life (QOL). Methods . This is a randomized, multi-centered, controlled clinical trial in which Medicare beneficiaries with a history of hospitalization within one year were randomized to standard care or standard care + a technology driven heart failure monitoring system. Primary end points were clinically meaningful change in functional capacity [6-minute walk distance (6MWD) or 6-minute work (6MW)] and QOL [Minnesota Living with Heart Failure Questionnaire (MLHF)] after 6-months of follow-up. Regression to the mean effects were estimated and adjusted according to the Edwards-Nunnally (EN) method. Clinically meaningful change is then defined in terms of the standard error of measurement (SEM) criterion. Results . Two hundred eighty four patients from three centers in USA were randomized. Mean age was 74 +/- 9 yrs, 58% were male, 82% were Caucasians, and New York Heart Association class II (31%), III (59%), and IV (10%). The change in functional capacity in terms of 6WD was 42 m, by 6MW was 3668 kg/m of work, and change in QOL in terms of MLHF total score by 6.0, physical dimension score by 4.0, and emotional dimension score by 2.0 from baseline. Body mass index, Left ventricular Ejection Fraction, beta-blocker usage and intra-cardiac device (ICD) implantation were the best clinically relevant predictors of change in functional capacity. Technology driven heart failure management did not result in a clinically meaningful incremental benefit in functional capacity or in QOL. Conclusions . There is no significant clinically meaningful benefit in functional capacity or in QOL from technology driven HF monitoring system in NYHA class II-IV elderly HF patients. Further, monitoring HF patients increased outpatient care resource utilization and costs, and was associated with a significantly poorer QOL.

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