Improving Efficiency of Clinical Studies Using a Total Digital Approach: Prospective Observational Study

Area of Science:

• Cardiology
• Digital Health
• Clinical Research

Background:

• Traditional clinical studies face lengthy recruitment periods, often hindered by in-person informed consent processes.
• Web-based techniques, including e-authentication (BankID) and digital electrocardiogram (ECG) monitoring, offer potential solutions to accelerate participant inclusion.
• These digital methods can improve adherence and extend study reach to remote geographical areas.

Purpose of the Study:

• To assess the feasibility of rapid, large-scale participant recruitment using a fully digital approach for study information and informed consent.
• To evaluate the effectiveness of digital ECG monitoring with instant mobile feedback on participant adherence.
• To determine if this digital strategy enhances geographical diversity and participant age span.

Main Methods:

• A 2-month study involving women with palpitations utilized a handheld ECG device (Coala Heart Monitor) connected to smartphones/tablets for immediate results.
• Participant recruitment, study information dissemination, and informed consent signing were conducted entirely online using BankID for authentication.
• Data collection involved ECG recordings and pre- and post-study questionnaires.

Main Results:

• Over 25 days, 1082 women were enrolled, with 1020 meeting inclusion criteria and 913 completing the study.
• A 9% dropout rate was observed, with 101,804 ECG recordings collected in total.
• Participants showed excellent adherence, with a mean age of 56 years (range 21-88), and were evenly distributed geographically.

Conclusions:

• A fully digital recruitment strategy successfully enrolled 1082 participants in 25 days, achieving broad geographical and age distribution.
• The digital approach demonstrated excellent adherence and inclusivity, reaching elderly participants effectively.
• This method is particularly advantageous during pandemics, minimizing physical contact and facilitating remote participation.