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CLINICAL TRIALS

• More data points Home telemonitoring enables subjects to monitor vital signs one or more times each day, for extended periods of time. There is no other practical way to achieve this level of data density.
• Pharmacokinetic data By monitoring vital signs at different times of the day, especially before and after drug doses, pharmacokinetics can be studied in a large population. For example, home blood pressure monitoring just before an antihypertensive dose is superior to both ambulatory and office monitoring in assessing trough-level drug efficacy.^1,2
• More reliable data Use of automatic monitors with electronic memory reduces observer bias, errors in technique and recording errors. For example, automatic blood pressure monitors eliminate the well-documented terminal digit preference, which leads to an undue number of pressures ending in 5 and 0. In one recent clinical study, more than 50% of nurse- and physician-measured blood pressures had to be discarded due to errors in technique discovered near the end of the trial. Upload of data that cannot be edited by the subject also eliminates the accidental and intentional errors in manual log books that have been widely documented.
• Increased power Large numbers of readings from each subject diminishes the impact of within-subject variability, increasing statistical power. In a recent study, the authors conclude “The characteristics of home blood pressure contribute to minimizing the number of subjects necessary for assessment of antihypertensive drug effects in comparative studies between an active treatment and placebo.³
• Symptom and side effects monitoring The Interactive Voice Response (IVR) system can be used to query subjects about signs and symptoms of their disease, and of potential side effects of treatment. Assessing these signs and symptoms daily can reduce the number of office visits required to assess efficacy and safety.
• Better compliance with study regimen Several studies have shown that home monitoring increases medication compliance. ^4,5 The IVR can be used to query subjects about medication compliance each day. Although not always perfect, recall of medication consumption in the last few hours is considerably better than recall in the preceding weeks or months. Asking about medication compliance each time subjects send data also reinforces the importance of good compliance, and reminds them of the cause-and-effect relationship of medication usage and clinical results.

We also track telemonitoring compliance daily, and have several features that promote self monitoring. Each time a subject sends readings, the IVR reminds him/her when to send the next set of readings. An audible and visible alarm reminds the subject if s/he forgets to send on schedule, and our customer service agents call subjects if they fail to send on schedule.

• More efficient data collection and analysis Because subjects monitor at home and upload data stored in their monitors, there is less need for trial monitors to visit trial sites to transcribe data. Problems of data security and HIPAA compliance are greatly reduced, because less data are collected and stored at each trial site. All data are immediately stored in our database, and complete interim data are available to study personnel as needed.
• Central data repository LifeLink Monitoring maintains all telemonitoring data in a secure, fully HIPAA-compliant SQL Server database. Data are backed up hourly on site, and weekly off site. In addition to reports to clinicians and study personnel, raw data are exported to SPSS, SAS and other statistical packages, and to all commonly-used relational databases.
• Convenience for subjects and clinicians Home telemonitoring offers greater convenience for patients, clinicians and researchers, including fewer office visits and less data collection, download and management in the clinician’s office.
• Cost reduction Low equipment costs, reduced need for site visits for data collection and review, and less nurse and physician time make automated home telemonitoring a cost-effective, patient- and clinician-friendly way to collect quality data in clinical trials.

In summary, LifeLink Monitoring offers clinical trials fewer site visits by trial monitors, reduced risk of clinician bias, fewer office visits, high acceptance by subjects and clinicians, symptom monitoring, accurate assessment of trough-level efficacy, no manual data transcription, no transcription errors, centralized oversight to identify poor compliance early enough to intervene, full database management and extract capability, data delivered electronically all at lower cost than ambulatory blood pressure monitoring or office monitoring.

¹Beltran B et al. Early morning rise of blood pressure at the end of the dose interval: comparison of ambulatory and self-measured blood pressure. J Hypertens 1998; 5(suppl 2).
²Sobrino J et al. When should blood pressure be measured in treated hypertensive patients? J Hypertens 1998; 5(suppl 2).
³Imai Y et al. Usefulness of home blood pressure measurement in assessing the effect of treatment in a single-blind placebo-controlled open trial. J Hypertens 2001; 19:179-185.
⁴Stahl S et al. Effects of home blood pressure measurement on long-term BP control. Am J Public Health 1984; 74:704.
⁵Friedman RH et al. A telecommunications system for monitoring and counseling patients with hypertension. Impact on medication adherence and blood pressure control. Am J Hypertens 1996; 9:285-292.