Advances in information technology and near ubiquity of the Internet have spawned novel modes of communication and unprecedented insights into human behavior via the digital footprint. Health behavior randomized controlled trials (RCTs), especially technology-based, can leverage these advances to improve the overall clinical trials management process and benefit from improvements at every stage, from recruitment and enrollment to engagement and retention. In this paper, we report the results for recruitment and retention of participants in the SMART study and introduce a new model for clinical trials management that is a result of interdisciplinary team science. The MARKIT model brings together best practices from information technology, marketing, and clinical research into a single framework to maximize efforts for recruitment, enrollment, engagement, and retention of participants into a RCT. These practices may have contributed to the study's on-time recruitment that was within budget, 86% retention at 24 months, and a minimum of 57% engagement with the intervention over the 2-year RCT. Use of technology in combination with marketing practices may enable investigators to reach a larger and more diverse community of participants to take part in technology-based clinical trials, help maximize limited resources, and lead to more cost-effective and efficient clinical trial management of study participants as modes of communication evolve among the target population of participants.
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http://dx.doi.org/10.1016/j.cct.2015.04.002 | DOI Listing |
J Med Internet Res
January 2025
Vibrent Health, Inc, Fairfax, VA, United States.
Background: Longitudinal cohort studies have traditionally relied on clinic-based recruitment models, which limit cohort diversity and the generalizability of research outcomes. Digital research platforms can be used to increase participant access, improve study engagement, streamline data collection, and increase data quality; however, the efficacy and sustainability of digitally enabled studies rely heavily on the design, implementation, and management of the digital platform being used.
Objective: We sought to design and build a secure, privacy-preserving, validated, participant-centric digital health research platform (DHRP) to recruit and enroll participants, collect multimodal data, and engage participants from diverse backgrounds in the National Institutes of Health's (NIH) All of Us Research Program (AOU).
J Med Internet Res
January 2025
Indiana University, Indianapolis, IN, United States.
Background: Heart failure (HF) is one of the most common causes of hospital readmission in the United States. These hospitalizations are often driven by insufficient self-care. Commercial mobile health (mHealth) technologies, such as consumer-grade apps and wearable devices, offer opportunities for improving HF self-care, but their efficacy remains largely underexplored.
View Article and Find Full Text PDFERJ Open Res
January 2025
Critical Care Department, Hospital Garcia de Orta EPE, Almada, Portugal.
Introduction: The number of vertical artefacts (VAs) in lung ultrasound (LUS) impacts patients' clinical management. This study aimed to demonstrate the influence of ultrasound settings on the number of VAs in patients under invasive mechanical ventilation (IMV).
Methods: Patients under IMV were recruited for LUS, including three breathing cycles with a motionless curvilinear probe on the thoracic region with the most VAs.
Neurol Clin Pract
April 2025
Brigham MS Center (MKH), Harvard Medical School, Boston, MA; Georgia State University (MCM), Atlanta; Brigham and Women's Hospital (TDM, JP-P, CS, JZ), Boston, MA; Massachusetts General Hospital (ECK), Harvard Medical School, Boston, MA; University of Vermont (AJS), Burlington; Elliot Lewis MS Center (EL, JK), Wellesley, MA; University of Massachusetts (CI, IB), Worcester, MA; Novartis Pharmaceuticals (JMS), Jersey City, NJ; Concord Hospital (AC), NH; and University of British Columbia (ADS), Vancouver, BC, Canada.
Background And Objectives: Multiple sclerosis (MS) affects more than 1 million people in the United States, including reproductive-age women. There has been a paucity of prospective, pregnancy registries based on MS disease rather than medication exposures. A prospective MS pregnancy registry (PREG-MS) was established in 2017 as a prospective, single-cohort, real-world MS pregnancy registry in New England States of the United States, with goals to evaluate (1) course of MS and disease-modifying therapies (DMT) use during conception attempts and in the peripartum period, (2) pregnancy outcomes in women with MS (WwMS), and (3) longer-term developmental outcomes in offspring of WwMS.
View Article and Find Full Text PDFContemp Clin Trials Commun
February 2025
Division of Health Systems, Policy, and Innovation, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Introduction: Individuals with esophageal and gastroesophageal junction (GEJ) cancers are at especially high risk of malnutrition. However, most patients with malnutrition do not receive adequate nutritional support. We conducted a single-arm trial to test the implementation of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital intervention to improve nutritional outcomes for patients with locally advanced esophageal and gastroesophageal junction cancer.
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