Leveraging TrialKit to Overcome Participant Compliance Challenges in a Medical Device Study

Background

Catalyst Clinical Research (Catalyst), a leading multi-therapeutic, global contract research organization (CRO) partnered with an innovative medical device company committed to helping people gain control of how they look and feel through the use of non-invasive neurostimulation technology. They launched a medical device clinical trial, seeking to assess the effectiveness of a new transcutaneous electrical nerve stimulation (TENS) device in helping patients lose weight. The multicenter, randomized, blinded, parallel group, controlled study involved 395 participants with the goal to demonstrate the effectiveness of the client’s device combined with a moderate intensity lifestyle therapy program as compared to an identical, sham device alongside a moderate intensity lifestyle therapy program. 

Challenge

The study required a scheduler that would allow an outside dietitian group to provide coaching sessions to patients. Catalyst needed an eClinical platform that could streamline and simplify patient engagement as well as to help monitor compliance. Specifically, it needed to provide a more intuitive scheduling process that would make it easier for patients to adhere to the study protocol, all while seamlessly integrating into existing workflows. This solution also needed to be easy to roll out to keep costs down while still ensuring data privacy and security. 

Solution

To address these challenges, Catalyst employed the TrialKit platform, including its Electronic Data Capture (EDC) system and TrialKit Engage for virtual visits. Participants would interact with the platform via provisioned Samsung smart devices or their own device using TrialKit’s mobile app.

TrialKit Engage provided an easy-to-use calendar function allowing sites to schedule  dietitian appointments for the patients, making it much simpler for them to comply with required scheduled visits. TrialKit’s intuitive interface helped mitigate initial compliance issues. For example, TrialKit Engage’s virtual visit capability allowed participants to meet with dietitians remotely, which was especially beneficial for those who lived far from the site or with scheduling conflicts.

Crucial Data Solutions supported the Catalyst team throughout the onboarding and training process, ensuring the platform was fully integrated into their existing workflows. 

Results

The implementation of TrialKit EDC and TrialKit Engage led to significant improvements in patient compliance, a critical factor in the study’s success. Although specific metrics were not disclosed, the study team reported that the platform’s user-friendly design contributed to:

• Ease of scheduling through the EDC platform for the sites
• Improved adherence to the study protocol
• More flexible patient engagement via TrialKit Engage virtual visits
• Enhanced accessibility to the platform via TrialKit’s mobile app
• Protected patient information in compliance with HIPAA regulations, providing peace of mind for both the participants and the study team

Further, the seamless integration of TrialKit with the study’s existing systems minimized disruptions and ensured that the study remained on track.

Summary

Catalyst successfully leveraged the TrialKit platform for a TENS device study to overcome initial challenges with centralized scheduling and patient compliance. The platform’s intuitive design and the support from Crucial Data Solutions played a key role in the study’s progress. Catalyst expressed satisfaction with the platform’s performance and indicated a willingness to use TrialKit and TrialKit Engage in future studies, as well as to recommend the solution to others with similar needs.

If your study is facing challenges with scheduling, patient compliance or engagement, discover how TrialKit can streamline your processes and improve outcomes. Contact us today to learn more.