NIH-Granted Study: A randomized, placebo controlled, double blind testosterone trial
Optimal matching of Interactive Voice and Web Response Technology modes to the specific needs of the trial resulted in better overall quality of the trial.
- Voice collected ePRO showed better subject compliance and higher quality real-time data.
- Web Technology improved site management, with automated calculated algorithms, virtually immediate updates, and real-time notifications and reporting.
Objective: Evaluate efficacy of treatment v. placebo control
- Interactive Voice Response System (IVRS) for subject surveys
- Verified conversion from standard validated paper questionnaires
- Increased subject survey compliance
- Collect better quality of data from subjects
- Interactive Web Response System (IWRS) for investigative sites
- Easily manage subject recruitment and enrollment
- ~790 hypogonadal males, 65 or older
- 1 year treatment duration, 5+ year study
- Approximately 12 multi-center US locations
- Subjects were randomized to treatment or placebo group
- Make it easy to determine eligibility to study, and to substudies
- Provide optimal mode of collecting subject questionnaire data, and enhance compliance
The objective of this study was to evaluate older men with hypogonadism and to determine the effect of randomized treatment, (testosterone gel or placebo gel) to changes in a variety of standardized endpoints collated during a one-year treatment period.
Each subject participated in at least one of five sub-trials, most of which collected information from subjects using validated paper surveys, interviewer administered questionnaires, physical tests, and our IVRS ePRO survey system. The primary and secondary outcomes of each individual trial were evaluated in all participants.
What We Did
Subjects were recruited primarily through mass mailings. 51,085 men were screened and 790 subjects who met all criteria were enrolled over the 5+ years of the trial. Respondents were screened first by telephone interview and then during two clinical visits. Subjects were asked pre-validated paper ‘Quality of Life’ questionnaires by a site coordinator who then input their information to our secure IWRS, in order to determine sub-trial eligibility for which they met enrollment criteria. This web-based “Control Panel” enabled site coordinators to enroll subjects to applicable sub-trials, and to keep real-time track of enrollments across 12 sites.
We programmed and installed the appropriate IVRS mode questionnaires to be made available to those subjects enrolled in specific sub-trials, accommodating scheduled time windows for subject completion. Subjects made toll-free phone calls from virtually any compatible phone. Because the IWRS used by the sites integrated with the IVRS database, any evidence of subject survey activity/inactivity was shared between the systems and coordinators were easily able to monitor and manage subjects’ ePRO compliance in real-time.
How We Did It
Validated paper instruments, including the PANAS, FACIT-Fatigue, SF-36, UCLA 7-day Sexual Function Diary (PDQ-Q4), Patient Global Impression of Change (PGIC) Questions, and PHQ-9 Depression Score, were converted and duplicated to our IVRS-telephone data capture mode of collection. Two PILOT studies were conducted in advance of this main study, in which these IVRS version surveys were administered, analyzed and pre-validated to determine proof of acceptable correlation to paper mode. Answers collected by each method, paper or telephone were identified to be statistically indistinguishable.
Our database contained all the information entered by site coordinators via IWRS, and surveys entered by subjects via IVRS. The site coordinators entered confirmation of completed study visits using the IWRS Control Panel, which triggered the next scheduled availability of subject’s IVRS survey. Critical IVRS survey PHQ-9 suicide alerts and non-compliance status notifications were supplied to site personnel in real-time for site follow-up, providing automated management assistance.
Data collected by our IVR/IWR systems were electronically transferred to the clinical final study database with efficient and real-time updates, requiring no intervention from study personnel; this eliminated data input/transfer errors and overall data collection costs, reduced subject enrollment time, and optimized enrollment accuracy.
IVRCC proved to be an excellent fit for the size and type of this particular study: older subjects, entering a significant number of data points based on enrollment to one or more sub-trials, over several sites, over different time zones, during the day and night, over different time windows, on different schedules, using a familiar, comfortable phone system that was very user-friendly for this subject demographic.
The study was executed successfully and our validated instruments provided a more efficient, automated electronic method to collect original source data in a cost-effective manner. IVRCC was able to provide an affordable and adaptable solution that provided data that was easy to integrate with the final EDC database. The study article was recently published in The New England Journal of Medicine.
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