The ExACT CM Microprocessor-Based Compliance Recording Device: Product Description and Field Testing Results

Objective:

To conduct field testing of the ExACT CM compliance monitoring device and provide results to the manufacturer.

Design:

Questionnaires, interviews, and patient diaries were used to collect data on targeted product attributes of interest.

Setting:

The Veterans Affairs Medical Center outpatient anticoagulation clinic in Tucson, AZ.

Subjects:

A convenience sample of 31 ambulatory male patients (average 68 ± 0.5 y) who had been stabilized on warfarin therapy for at least one month.

Main Outcome Measures:

Scaled attitudinal scores and open-ended comments on device attributes.

Results:

Data were collected for 28 days per patient. The device was determined to be both functional and acceptable to patients.

Conclusions:

Results suggest that it is feasible to market ExACT CM for use by the pharmaceutical industry in clinical research.