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Published on: February 26, 2013
Augmenting Engagement in Decentralized Clinical Trials for Atrial Fibrillation: Development and Implementation of a
Toluwa Daniel Omole1, Andrew Mrkva2, Danielle Ferry2
1University of Pittsburgh School of Medicine, 3609 Forbes Avenue, Second floor, Pittsburgh, PA, United States.
Insights
Remote clinical trials enhanced diversity in atrial fibrillation (AF) research by using digital technology and mobile health interventions. This approach improved medication adherence and offers a model for future cardiovascular studies.
Area of Science:
- Cardiovascular Medicine
- Digital Health
- Clinical Trial Methodology
Background:
- Atrial fibrillation (AF) management requires long-term patient adherence to medications and self-monitoring.
- Clinical trials for AF often lack diversity in sex, race, ethnicity, and rural residence, limiting generalizability.
- Digital technology and remote strategies can improve recruitment of underrepresented populations in clinical trials.
Purpose of the Study:
- To summarize a research program's architecture designed to enhance geographic and demographic diversity in mobile health trials.
- To improve medication adherence in patients with atrial fibrillation through remote methods.
Main Methods:
- Developed a remote recruitment and assessment program for two National Institutes of Health-funded randomized clinical trials in AF patients.
- Utilized smartphone-based relational agents to test effectiveness on oral anticoagulation adherence.
- Employed remote methods (mail, telephone) for consent, randomization, training, and retention, accommodating varying health and digital literacy levels.
Main Results:
- Enrolled 513 participants, exceeding recruitment goals for rural and metropolitan populations.
- Achieved significant diversity: 62% women, 31% underrepresented minorities in the metropolitan study.
- Demonstrated high retention (over 89% at 12 months) and participant engagement with the mobile health intervention.
Conclusions:
- Successfully developed and implemented a programmatic architecture for remote clinical trials.
- Enhanced trial diversity and composition, offering an innovative mobile health intervention for AF medication adherence.
- Provided a model for improved recruitment and engagement of diverse participants in cardiovascular trials.
Background:
Atrial fibrillation (AF) is a chronic cardiovascular condition that requires long-term adherence to medications and self-monitoring. Clinical trials for AF have had limited diversity by sex, race and ethnicity, and rural residence, thereby compromising the integrity and generalizability of trial findings. Digital technology coupled with remote strategies has the potential to increase recruitment of individuals from underrepresented demographic and geographic populations, resulting in increased trial diversity, and improvement in the generalizability of interventions for complex diseases such as AF.
Objective:
This study aimed to summarize the architecture of a research program using remote methods to enhance geographic and demographic diversity in mobile health trials to improve medication adherence.
Methods:
We developed a programmatic architecture to conduct remote recruitment and assessments of individuals with AF in 2 complementary randomized clinical trials, funded by the National Institutes of Health, to test the effectiveness of a smartphone-based relational agent on adherence to oral anticoagulation. The study team engaged individuals with either rural or metropolitan residences receiving care for AF at health care settings who then provided consent, and underwent baseline assessments and randomization during a remotely conducted telephone visit. Participants were randomized to receive the relational agent intervention or control and subsequently received a study smartphone with installed apps by mail. Participants received a telephone-based training session on device and app usage accompanied by a booklet with pictures and instructions accessible for any level of health or digital literacy. The program included remote methods by mail and telephone to promote retention at 4-, 8-, and 12-month visits and incentivized return of the smartphone following study participation. The program demonstrated excellent participant engagement and retention throughout the duration of the clinical trials.
Results:
The trials enrolled 513 participants, surpassing recruitment goals for the rural (n=270; target n=264) and metropolitan (n=243; target n=240) studies. A total of 62% (319/513) were women; 31% (75/243) of participants in the metropolitan study were African American, Asian, American Indian or Alaskan native or other races or ethnicities, in contrast to 5% (12/270) in the rural study. Among all participants, 56% (286/513) had less than an associate's degree and 44% (225/513) were characterized as having limited health literacy. Intervention recipients receiving the relational agent used the agent median of 95-98 (IQR, 56-109) days across both studies. Retention exceeded 89% (457/513) at 12 months with study phones used for median 3.3 (IQR, 1-5) participants.
Conclusions:
We report here the development and implementation of a programmatic architecture for the remote conduct of clinical trials. Our program successfully enhanced trial diversity and composition while providing an innovative mobile health intervention for medication adherence in AF. Our methods provide a model for enhanced recruitment and engagement of diverse participants in cardiovascular trials.
