title: Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model.
abstract: 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.
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States. Electronic address: agupta@sanfordburnham.org.
authors: Anjali
authors: A
authors: Gupta
authors: Joint Doctoral Program in Clinical Psychology at SDSU/UCSD and Student Health and Well-being UC San Diego Health System, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Karen J
authors: KJ
authors: Calfas
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Simon J
authors: SJ
authors: Marshall
authors: Stanford Solutions Science Lab, Division of General Pediatrics, Department of Pediatrics and Stanford Prevention Research Center, Department of Medicine, Stanford, CA 94305, United States.
authors: Thomas N
authors: TN
authors: Robinson
authors: Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Cheryl L
authors: CL
authors: Rock
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States; Rady Children's Hospital, San Diego, CA 92123, United States; Department of Pediatrics, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Jeannie S
authors: JS
authors: Huang
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Melanie
authors: M
authors: Epstein-Corbin
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Christina
authors: C
authors: Servetas
authors: Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Michael C
authors: MC
authors: Donohue
authors: Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Gregory J
authors: GJ
authors: Norman
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Fredric
authors: F
authors: Raab
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Gina
authors: G
authors: Merchant
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States; Medical Genetics Division and Political Science Department, University of California, San Diego, La Jolla, CA 92093, United States.
authors: James H
authors: JH
authors: Fowler
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States; Department of Computer Science and Engineering, University of California, San Diego, La Jolla, CA 92093, United States.
authors: William G
authors: WG
authors: Griswold
authors: Behavior Design Lab, Stanford University, Stanford, CA 94305, United States.
authors: B J
authors: BJ
authors: Fogg
authors: Center for Wireless and Population Health Systems, Calit2, University of California, San Diego, La Jolla, CA 92093, United States; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA 92093, United States.
authors: Kevin
authors: K
authors: Patrick
mesh_terms: D000293:Adolescent; D000328:Adult; D003142:Communication; D017598:Efficiency, Organizational; D005006:Ethnicity; D005260:Female; D015438:Health Behavior; D006801:Humans; D020407:Internet; D008297:Male; D040541:Marketing / Q000458:organization & administration*; D018579:Patient Selection; D044469:Racial Groups; D012107:Research Design; D012737:Sex Factors; D061108:Social Media; D060756:Social Networking; D013334:Students; D014495:Universities; D015431:Weight Loss; D055815:Young Adult
keywords: Behavior; Clinical trial management; Intervention; Marketing; Social media; Technology