Abstract

BackgroundParticipant recruitment for clinical trials is a significant challenge for the scientific research community. Federal funding agencies have made continuation of funding of clinical trials contingent on meeting recruitment targets. It is incumbent on investigators to carefully set study recruitment timelines and resource needs to meet those goals as required under current funding mechanisms. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states.MethodsQuantitative and qualitative data on recruitment were gathered from study staff throughout the study recruitment period and were used to calculate costs and effort. The study utilized two main approaches to recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff.ResultsContact was attempted with 18,925 people to obtain the enrolled sample of 140. The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant. Qualitative evaluations identified multiple barriers to recruitment.ConclusionsRecruitment for Program ACTIVE II exemplifies the magnitude of resources needed to reach recruitment targets in the current era. Continuous evaluation, flexibility, and adaptation are required on the part of investigators, community partners, and funding agencies to successfully reach high-risk populations in rural and urban areas.Trial registrationClinicalTrials.gov, NCT03371940. Registered on 13 December 2017.

Highlights

  • Participant recruitment for clinical trials is a significant challenge for the scientific research community

  • The purpose of the study was to test the comparative effectiveness of manualized exercise (EX) and cognitive behavioral (“talk”) therapies (CBT) for the treatment of depression, individually or in combination (EX+cognitive behavioral therapy (CBT)), against usual care (UC)

  • Research staff trained in the study protocol and approved by the local site Institutional Review Boards (IRB) conducted all contacts with potential participants to assess their interest and eligibility

Read more

Summary

Introduction

Participant recruitment for clinical trials is a significant challenge for the scientific research community. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states. Critical to the success of these trials is recruitment of study participants in order to have sufficient statistical power to detect the effects of interventions [1]. Recruitment is increasingly challenging for clinical trials across all domains of health research, for studies recruiting from the community. Mental health studies can be challenging for recruitment. For those with major depressive disorder (MDD), withdrawal from regular activities is common.

Objectives
Methods
Results
Discussion
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call