Enrollment and Retention Outcomes from the Veterans Health Administration for a Remote Digital Health Study:...

Area of Science:

• Digital Health
• Clinical Trial Methodology
• Remote Patient Monitoring

Background:

• Remote digital health studies face challenges with patient enrollment and retention.
• Large integrated health systems, like the Veterans Affairs (VA), offer a substantial patient pool for clinical trials.
• The VA population is generally older with more comorbidities, representing a key demographic for health studies.

Purpose of the Study:

• To assess enrollment and retention outcomes of a remote patient monitoring (RPM) device study conducted with VA patients.
• To leverage the VA's extensive network for a digital health study involving a multisensor device.
• To identify factors influencing enrollment and completion in a remote clinical trial setting.

Main Methods:

• Enrolled 203 VA patients with a history of COVID-19 and pre-existing conditions in a study using a cellular-enabled RPM device.
• Utilized VA's Corporate Data Warehouse to identify potentially eligible patients for remote recruitment via mail.
• Conducted all study procedures, including consent and training, online and via telephone, collecting device, survey, and clinical data.

Main Results:

• Achieved a 2.9% enrollment yield from 7714 mailed invitations, enrolling 203 patients.
• Attained an 82% retention rate, with 166 patients completing the study.
• The primary reason for non-completion was the inability to contact participants for study tasks.

Conclusions:

• Recruiting through the VA system provides access to a large patient population, enhancing the success of remote digital health studies.
• The VA's integrated health system is a valuable resource for achieving enrollment and completion targets in clinical trials.
• Strategies to overcome contact challenges are crucial for improving retention in remote studies.