Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes

Barbara A. Myers, Yegan Pillay, W. Guyton Hornsby, Jay Shubrook, Chandan Saha, Kieren J. Mather, Karen Fitzpatrick, Mary De Groot

Research output: Contribution to journalArticle

Abstract

Background: Participant 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. Methods: Quantitative 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. Results: Contact 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. Conclusions: Recruitment 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 registration: ClinicalTrials.gov, NCT03371940. Registered on 13 December 2017.

Original languageEnglish (US)
Article number621
JournalTrials
Volume20
Issue number1
DOIs
StatePublished - Nov 6 2019

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Type 2 Diabetes Mellitus
Randomized Controlled Trials
Costs and Cost Analysis
Research Personnel
Clinical Trials
Personnel Selection
Urban Population
Rural Population
Research

Keywords

  • Clinical trial
  • Depression
  • Diabetes
  • Study recruitment

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes. / Myers, Barbara A.; Pillay, Yegan; Guyton Hornsby, W.; Shubrook, Jay; Saha, Chandan; Mather, Kieren J.; Fitzpatrick, Karen; De Groot, Mary.

In: Trials, Vol. 20, No. 1, 621, 06.11.2019.

Research output: Contribution to journalArticle

Myers, Barbara A. ; Pillay, Yegan ; Guyton Hornsby, W. ; Shubrook, Jay ; Saha, Chandan ; Mather, Kieren J. ; Fitzpatrick, Karen ; De Groot, Mary. / Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes. In: Trials. 2019 ; Vol. 20, No. 1.
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