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. 2014 Dec 1;4(12):1065-1081.
doi: 10.4155/cli.14.99.

An evaluation of recruitment methods utilized for a clinical trial with periodontal and diabetes enrollment criteria: the Diabetes and Periodontal Therapy Trial

Elinor R Schoenfeld  1 , Leslie Hyman  1 , Leslie Long Simpson  2 , Bryan Michalowicz  3 , Michael Reddy  4 , Marie Gelato  5 , Wei Hou  1 , Steven P Engebretson  6 , Catherine Hytner  1 , Pat Lenton  7 ; the DPTT Study Group
Affiliations

An evaluation of recruitment methods utilized for a clinical trial with periodontal and diabetes enrollment criteria: the Diabetes and Periodontal Therapy Trial

Elinor R Schoenfeld et al. Clin Investig (Lond). .

Abstract

Background: Diabetes and its complications are a major United States public health concern.

Methods: The Diabetes and Periodontal Therapy Trial (DPTT) evaluated whether non-surgical treatment of periodontal disease influenced diabetes management among persons with Type 2 diabetes and periodontitis. The aim of this study was to evaluate DPTT's many recruitment strategies in terms of enrollment success.

Results/conclusion: Targeted recruitment strategies were more effective in identifying individuals who met periodontal and diabetes eligibility criteria. Individuals eligible for a baseline visit/enrollment were more often male, had a younger age at diabetes diagnosis, a longer diabetes duration, more often Hispanic and less often African-American. Tracking and evaluating recruitment sources during study enrollment optimized recruitment methods to enroll a diverse participant population based upon gender, race and ethnicity.

Keywords: Type 2; clinical trial; diabetes; diabetes mellitus; periodontal disease; periodontitis; recruitment.

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Conflict of interest statement

Financial & competing interests disclosure

ClinicalTrials.gov: NCT00997178. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Figures

Figure 1
Figure 1. Diabetes and Periodontal Therapy Trial recruitment flow including all screening visits
DPTT: Diabetes and Periodontal Therapy Trial.
Figure 2
Figure 2. Screening visit outcomes at the first screening visit based upon grouped eligibility criteria
See this image and copyright information in PMC

References

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