February 15, 2023: This Week’s PCT Grand Rounds Will Feature the Heartline Trial of the Apple Watch to Detect Atrial Fibrillation

Headshot of C. Michael GibsonIn this Friday’s PCT Grand Rounds, Dr. C. Michael Gibson of Harvard Medical School will present “The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials.”

The Grand Rounds session will be held on Friday, February 17, 2023, at 1:00 pm eastern.

Gibson is a professor of medicine at Harvard Medical School, an interventional cardiologist at Beth Israel Lahey Health, and CEO and president of the nonprofit Baim Institute for Clinical Research and the PERFUSE Study Group. He will discuss the Heartline trial, a virtual randomized controlled trial assessing the effectiveness of the Apple Watch in detecting new-onset atrial fibrillation to reduce stroke, myocardial infarction, and all-cause mortality.

Join the online meeting.

November 30, 2022: This Week in PCT Grand Rounds, a Pragmatic Trial of an mHealth Intervention for Heart Failure and Diabetes

Headshot of Dr. Michael FelkerIn this Friday’s PCT Grand Rounds, Dr. Michael Felker of Duke University will present “A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned.” The Grand Rounds session will be held on Friday, November 18, 2022, at 1:00 pm eastern.

Felker is a professor of medicine in the Duke University School of Medicine and the director of cardiovascular and metabolism research at the Duke Clinical Research Institute. Dr. Felker will discuss TARGET-HF-DM, a pragmatic trial that tested the effectiveness of a mobile health intervention to improve physical activity and medication adherence among patients with heart failure and diabetes mellitus.

Join the online meeting.

March 9, 2022: PCT Grand Rounds to Feature MIPACT Study and THRIVE Pragmatic Trial

Headshots of Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore
Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore

In this Friday’s PCT Grand Rounds, Dr. Sachin Kheterpal, Dr. Jessica Golbus, and Nicole Pescatore of the University of Michigan will present “Understanding a Patient’s Daily Experience Through Mobile Devices and Wearables: Lessons Learned From the 8000 Patient MIPACT Study and Implementation in a National Pragmatic Trial.” The Grand Rounds session will be held on Friday, March 11, at 1:00 pm eastern.

The Michigan Predictive Activity and Clinical Trajectories (MIPACT) study is a prospective observational study exploring whether data collected on an Apple Watch, combined with home blood pressure measurements and other health information, can provide insights into health and disease. The Trajectories of Recovery After Intravenous Propofol vs Inhaled Volatile Anesthesia (THRIVE) trial is a pragmatic trial of of intravenous vs inhalational general anesthesia in patients undergoing elective noncardiac surgery.

Join the online meeting.

November 19, 2021: Exploring Approaches in Using Digital and Mobile Health in Patient-oriented Research: Pearls and Pitfalls (Anish K. Agarwal MD, MPH MS)

Speaker

Anish K. Agarwal MD, MPH MS
Assistant Professor of Emergency Medicine
Clinical Innovation Manager, Penn Medicine Center for Health Care Innovation
University of Pennsylvania, Perelman School of Medicine

Topic

Exploring Approaches in Using Digital and Mobile Health in Patient-oriented Research: Pearls and Pitfalls

Keywords

Mobile health; Digital health; Patient-oriented research; Study design

Key Points

  • Digital and mobile health is a rapidly evolving field that integrates with the electronic health records in both low and high tech ways.
  • Dr. Agarwal conducted a randomized control trial of overweight veterans who had daily access to a smartphone or tablet. These participants were sent a wearable device to collect step count data.
  • An important consideration for studies using mobile health technology is participant access to a smart or mobile device. 85% of Americans have access to a Smartphone where 97% have access to a mobile device that can receive texts. 20% use a smartwatch.
  • Mobile methods are just tools to support overall study design.
  • Dr. Agrawal conducted a study on post-operative opioid prescribing and use. Data was gathered from participants via text messaging systems.
  • Simple text messages that are more conversational in nature are received better by the participant. Links in text messages should be limited. It’s important for participants to understand the privacy and security of their communications and data. Nudge a participant with a text at the right time to avoid being overbearing.

Discussion Themes

Let patients know that SMS is not secure, and frame questions to avoid patients sending HIPAA covered data via text.

A good relationship with your institutions Privacy and Safety office is fundamental to navigating IRB regulations for research with digital and mobile devices.

 

Read more about Dr. Agarwal’s studies using mobile health devices: Effect of Gamification With and Without Financial Incentives to Increase Physical Activity Among Veterans Classified as Having Obesity or Overweight: A Randomized Clinical Trial and Patient-Reported Opioid Consumption and Pain Intensity After Common Orthopedic and Urologic Surgical Procedures With Use of an Automated Text Messaging System.

 

Tags

#pctGR, @Collaboratory1

November 17, 2021: PCT Grand Rounds to Explore Digital and Mobile Health in Patient-Oriented Research

Headshot of Dr. Anish Agarwal
Dr. Anish Agarwal

In this Friday’s PCT Grand Rounds session, Dr. Anish Agarwal of the University of Pennsylvania will present “Exploring Approaches in Using Digital and Mobile Health in Patient-Oriented Research: Pearls and Pitfalls.”

Dr. Agarwal is an assistant professor of emergency medicine at Penn and the clinical innovation manager at the Penn Medicine Center for Health Care Innovation.

The Grand Rounds session will be held on Friday, November 19, at 1:00 pm eastern. Join the online meeting.

May 7, 2021: Online Recruitment in the Era of COVID-19: Pitfalls and Progress (Megan L. Ranney, MD, MPH)

Speaker

Megan L. Ranney, MD, MPH, FACEP
Director, Brown-Lifespan Center for Digital Health
Warren Alpert Endowed Associate Professor of Emergency Medicine, Brown University
Associate Dean of Strategy and Innovation, School of Public Health, Brown University
Chief Research Officer, AFFIRM
Co-founder, GetUsPPE

Topic

Online Recruitment in the Era of COVID-19: Pitfalls and Progress

Keywords

COVID-19; Online trial recruitment; Clinical trials; Emergency medicine; Digital health technologies; Remote interventions; Electronic informed consent

Key Points

  • The Center for Digital Health at Brown University is a research and education hub that explores innovative solutions to urgent health challenges. The Center has supported studies involving the use of digital health technologies for recruiting participants and delivering behavioral health interventions.
  • Due to disruptions caused by the COVID-19 pandemic, many research studies pivoted from in-person contact toward the use of digital technologies such as smartphone apps and remote telehealth.
  • To advance clinical trials in a post-pandemic world, we will need to establish best practices for digital health technologies—and recognize when online recruitment is appropriate and when it is not. Hybrid recruitment models offer a solution.

Discussion Themes

It remains clear that the relationship between study staff and participants is essential to forming positive alliances and determines the likelihood of follow up.

For social media advertising, it’s possible that an IRB could approve a group of images, headlines, and content that study teams can combine in different ways to optimize the advertising over the course of a study.

The Pew Research Center provides recent data on which social media platforms are used most by Americans. Read more about digital health science at the Center for Digital Health.

Tags

#pctGR, @Collaboratory1

March 12, 2021: Lessons Learned from the Gates MRI Virtual COVID-19 Trial (Mohamed Bassyouni, PharmD; Jintanat Ananworanich, MD, PhD)

Speakers

Mohamed Bassyouni, PharmD
Product Development Program Leader
Bill and Melinda Gates Medical Research Institute
Cambridge, MA
 
Jintanat Ananworanich, MD, PhD
Clinical Development Leader
Bill and Melinda Gates Medical Research Institute
Cambridge, MA

Topic

Lessons Learned from the Gates MRI Virtual COVID-19 Trial

Keywords

COVID-19; Virtual trial; Gates Medical Research Institute (MRI); Underserved populations; Health outcomes; Treatment safety and efficacy; Decentralized trial

Key Points

  • The goal of this study was to conduct a randomized controlled, adaptive platform trial to evaluate safety and efficacy of interventions for high-risk people with mild COVID-19 disease.
  • A key feature of the virtual trial was the development of a “COVID trial in a box.” This innovative method involved a single shipment of the study materials—including the study drug, lab sample kits, pulse oximeter, and PPE—directly to study participants’ homes.
  • The study evaluated multiple strategies for participant identification and outreach. Challenges included finding a better approach to engage minority communities; having better access for potential participants to be screened for COVID-19; increasing participation in the elderly population.

Discussion Themes

100% remote trials are possible and are especially crucial during a pandemic.

How did the study use social medial for virtual screening?

Did you do exit interviews with participants to get feedback on outreach and study design? 

Were alternatives to eConsent offered to patients who may have had technical difficulty with electronic apps or platforms?

Read more at the Gates Medical Research Institute website.

Tags

#pctGR, @Collaboratory1

January 29, 2021: The COVID-19 Citizen Science Study (Gregory M. Marcus, MD, MAS)

Speaker

Gregory M. Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

Topic

The COVID-19 Citizen Science Study

Keywords

Eureka digital research platform; COVID-19 infections; Mobile health; Risk factors; Citizen science; Geolocation; Participant engagement

Key Points

  • Eureka is an NIH-supported digital research platform built to use mobile health technology to combat the novel coronavirus, focusing on identifying risk factors for infection, transmission, and severity of disease that may inform best practices.
  • Eureka is also intended to serve as a platform for collaborating investigators to answer their own research questions.
  • As a citizen science project, any adult with a smartphone can participate and contribute information. Nearly 50,000 participants have enrolled to date.

Discussion Themes

The COVID-19 Citizen Science website provides data visualizations that show how people answered the survey questions. A study blog through the app is used to translate key information to participants.

Will this project be collaborating with other entities that are potentially overlapping in terms of their COVID-19 applications?

Best practices in mHealth include keeping it simple, avoiding over-explaining, listening to participants, and providing a feedback pathway.

Learn more about the Eureka platform. The smartphone app is available under the name “UCSF Eureka Research.”

Tags

#pctGR, @Collaboratory1  

January 26, 2021: NIH Collaboratory COVID-19 Grand Rounds Continues With the COVID-19 Citizen Science Study

Dr. Gregory MarcusIn this week’s COVID-19 Grand Rounds session, Dr. Gregory Marcus of the University of California, San Francisco, will present “The COVID-19 Citizen Science Study.” The Grand Rounds session will be held on Friday, January 29, at 1:00 pm eastern. Join the online meeting.

The Citizen Science Study is using a smartphone-based research platform to engage “citizen scientists” in advancing understanding of COVID-19. By collecting information from tens of thousands of participants, researchers hope to gain insights into how the coronavirus is spreading, identify ways to reduce the number of new infections, and determine how COVID-19 is affecting individuals and populations.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.