Table 3.
Primary and Secondary Outcomes with Collection Schedule
| Outcome | Measurement | Data Sources | Collection Schedule | ||||
|---|---|---|---|---|---|---|---|
| BLV | Months 1–12 | PCP | FUV | Chart Review | |||
| Primary | |||||||
| Change in diastolic, systolic, and mean blood pressure | Recorded blood pressure values taken by research coordinators blinded to randomization scheme | Cardinal Health Adult L & XL | X | X | |||
| Percent with controlled blood pressure | Recorded blood pressure values taken by research coordinators blinded to randomization scheme | Cardinal Health Adult L & XL | X | X | |||
| Secondary | |||||||
| Urine protein levels testing in previous 12 months | Chart Review; Self-report online survey | Medical Record review; Self-reported data by participants through online survey | X | X | X | ||
| Serum creatinine testing in previous 12 months | Chart Review; Self-report online survey | Medical Record review; Self-reported data by participants through online survey | X | X | X | ||
| Lifestyle counseling in previous12 months | Self-report online survey based on JNC7 guidelines* | Self-reported data by participants through online survey | X | X | |||
| Medication Intensiification | Prescriptions given by primary care physician | Self-report at BLV and FUV | X | X | |||
| Fidelity Measures | |||||||
| Utilization of the website | Percent of participants who used the website on a monthly basis | Monitoring of participant log-in on website | X | X | |||
| Study visit attendance | Percent of participants who attended the two study visits | Attendance of study visits | X | X | |||
*
7th Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure: JNC Express. 2003, U.S. Department of Health and Human Services: Bethesda, MD.