Cardiovascular Diversity Enrollment Case Study

September 25, 2024

CATEGORY : Case Study

Overview

  • Medical device study evaluating the use of a technology platform (smartphone app) to evaluate heart rate through fingertips
  • Study protocol required that 30% of the total enrollment (85) be subjects with a skin type of Fitzpatrick V or VI (brown and black skin tones)

Problem

  • Accurate fingertip readings can be more challenging with subjects of a darker skin tone

Solution

  • TOTAL identified seven sites that had immediate access to subjects who would meet the Fitzpatrick V and VI skin types
  • Enrollment was stratified where the Fitzpatrick V and VI subjects were enrolled first and then the remainder of enrollment for all other skin types was opened to finish complete enrollment

Results

  • Study enrolled three weeks early
  • 33 of the 26 required Fitzpatrick V and VI subjects was enrolled
  • Exceeded diversity goal by 27%

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