Literature DB >> 33857681

Recruitment and enrollment of participants in an online diabetes self-management intervention in a virtual environment.

Allison Vorderstrasse1, Louise Reagan2, Gail D'Eramo Melkus3, Sarah Y Nowlin3, Stacia B Birdsall3, Andrew Burd4, Yoon Hee Cho3, Myoungock Jang5, Constance Johnson6.   

Abstract

Effective recruitment of research participants is essential for successful randomized controlled trials and remains one of the most challenging and labor-intensive aspects of conducting research. The purpose of this manuscript is to describe recruitment methods for this two-group, internet-based intervention trial and enrollment status in relation to recruitment methods, accounting for accrual rates and recruitment costs and to discuss our recruitment results and limitations informed by the Clinical Trials Transformation Initiative (CTTI) team's evidence and expert-based recommendations for recruitment. The primary study was a two-group randomized controlled trial designed to evaluate the efficacy of a virtual environment, Diabetes LIVE©, compared to a traditional website format to provide diabetes self-management education and support to adults with type 2 diabetes. Our recruitment experience was labor-intensive, multimodal, and required multiple iterations throughout the study to meet recruitment goals. To allow for more efficient and realistic budgets aligned with funding, researchers should engage stakeholders in recruitment planning and monitor and report personnel time and cost by recruitment methods. To allow for more efficient and effective recruitment into meaningful clinical trials and of interest to participants, researchers should use a participative approach during all study phases, including question development.
Copyright © 2021 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Clinical trials; Diabetes; Internet research; Recruitment

Mesh:

Year:  2021        PMID: 33857681      PMCID: PMC8172527          DOI: 10.1016/j.cct.2021.106399

Source DB:  PubMed          Journal:  Contemp Clin Trials        ISSN: 1551-7144            Impact factor:   2.261


  29 in total

Review 1.  Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review.

Authors:  Caren Heller; Joyce E Balls-Berry; Jill Dumbauld Nery; Patricia J Erwin; Dawn Littleton; Mimi Kim; Winston P Kuo
Journal:  Contemp Clin Trials       Date:  2014-08-15       Impact factor: 2.226

Review 2.  Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.

Authors:  Luther T Clark; Laurence Watkins; Ileana L Piña; Mary Elmer; Ola Akinboboye; Millicent Gorham; Brenda Jamerson; Cassandra McCullough; Christine Pierre; Adam B Polis; Gary Puckrein; Jeanne M Regnante
Journal:  Curr Probl Cardiol       Date:  2018-11-09       Impact factor: 5.200

Review 3.  Incentives and disincentives to participation by clinicians in randomised controlled trials.

Authors:  J M Rendell; R D Merritt; J R Geddes
Journal:  Cochrane Database Syst Rev       Date:  2007-04-18

Review 4.  Increasing recruitment to randomised trials: a review of randomised controlled trials.

Authors:  Judith M Watson; David J Torgerson
Journal:  BMC Med Res Methodol       Date:  2006-07-19       Impact factor: 4.615

Review 5.  Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme.

Authors:  Stephen J Walters; Inês Bonacho Dos Anjos Henriques-Cadby; Oscar Bortolami; Laura Flight; Daniel Hind; Richard M Jacques; Christopher Knox; Ben Nadin; Joanne Rothwell; Michael Surtees; Steven A Julious
Journal:  BMJ Open       Date:  2017-03-20       Impact factor: 2.692

6.  Practical application of opt-out recruitment methods in two health services research studies.

Authors:  Christopher J Miller; James F Burgess; Ellen P Fischer; Deborah J Hodges; Lindsay K Belanger; Jessica M Lipschitz; Siena R Easley; Christopher J Koenig; Regina L Stanley; Jeffrey M Pyne
Journal:  BMC Med Res Methodol       Date:  2017-04-14       Impact factor: 4.615

7.  Patient perspectives on use of electronic health records for research recruitment.

Authors:  Laura M Beskow; Kathleen M Brelsford; Catherine M Hammack
Journal:  BMC Med Res Methodol       Date:  2019-02-26       Impact factor: 4.615

Review 8.  Designing and using incentives to support recruitment and retention in clinical trials: a scoping review and a checklist for design.

Authors:  Beth Parkinson; Rachel Meacock; Matt Sutton; Eleonora Fichera; Nicola Mills; Gillian W Shorter; Shaun Treweek; Nicola L Harman; Rebecca C H Brown; Katie Gillies; Peter Bower
Journal:  Trials       Date:  2019-11-09       Impact factor: 2.279

9.  Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis.

Authors:  Catherine Houghton; Maura Dowling; Pauline Meskell; Andrew Hunter; Heidi Gardner; Aislinn Conway; Shaun Treweek; Katy Sutcliffe; Jane Noyes; Declan Devane; Jane R Nicholas; Linda M Biesty
Journal:  Cochrane Database Syst Rev       Date:  2020-10-07

10.  The Inclusion of African-American Study Participants in Web-Based Research Studies: Viewpoint.

Authors:  Bekeela Watson; Dana H Z Robinson; Laura Harker; Kimberly R Jacob Arriola
Journal:  J Med Internet Res       Date:  2016-06-22       Impact factor: 5.428

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  1 in total

1.  Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey.

Authors:  Josefin Hagström; Joanne Woodford; Agnes von Essen; Päivi Lähteenmäki; Louise von Essen
Journal:  BMJ Open       Date:  2022-04-01       Impact factor: 2.692

  1 in total

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