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.

January 8, 2021: HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data (Emily O’Brien, PhD)

Speaker

Emily O’Brien, PhD
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences

Topic

HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data

Keywords

Vaccine development; COVID-19; Pandemic: Vaccine hesitancy; HERO-TOGETHER; Healthcare workers; Clinical outcomes: Observational study

Key Points

  • According to the World Health Organization, vaccine hesitancy refers to the delay in acceptance of, or refusal of, vaccines despite availability of vaccination services.

  • Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence. Hesitancy occurs on a continuum, from acceptance of all vaccines, to acceptance but doubt, to vaccine delayers, refusers, and deniers.

  • HERO-TOGETHER is a prospective, observational, multicenter cohort study of 20,000 adult U.S. healthcare workers who received a COVID-19 vaccine within the past 60 days. The study will collect data from participants that includes their experience with receiving the vaccine, medical history, unexpected medical care, safety events, and quality of life.

Discussion Themes

There is no universal best practice to address vaccine hesitancy in all its contexts. Locally tailored and multicomponent approaches will be needed.

How has the political environment influenced the hesitancy around receiving the COVID-19 vaccine?

What are your approaches to evaluating vaccine safety? What about safety for women during child-bearing years?

Read more about the HERO-TOGETHER study.

Tags

#pctGR, @Collaboratory1

April 13, 2020: New Living Textbook Chapter on Pragmatic Mobile Health (mHealth) Trials

A new chapter in the Living Textbook provides expert advice for investigators considering using mobile technologies in pragmatic clinical trials. The chapter outlines many of the possibilities, advantages, and challenges associated with mobile health (mHealth) interventions, with a particular focus on design and evaluation of these programs in pragmatic clinical trials.

“We will illustrate many design and evaluation challenges, culminating with a discussion of how these considerations influence the ongoing development of the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) project.”—Real-World Evidence: Mobile Health (mHealth)

For more on using real-world evidence in pragmatic trials, see the Living Textbook chapter Choosing and Specifying Endpoints and Outcomes.