abstract: 'Background: Due to underrepresentation of racial/ethnic minority and

  low-income groups in clinical studies, there is a call to improve the

  recruitment and retention of these populations in research. Pilot

  studies can test recruitment and retention practices for better

  inclusion of medically underserved children and families in sub-sequent

  clinical trials. We examined this using a school-based asthma

  intervention, in preparation for a larger clinical trial in which our

  goal is to include an underserved study population.Methods: We recruited

  children with poorly controlled asthma in a two-site pilot cluster

  randomized controlled trial of school-supervised asthma therapy versus

  enhanced usual care (receipt of an educational asthma work-book). We

  sought a study population with a high percentage of children and

  families from racial/ethnic minority and low-income groups. The primary

  outcome of the pilot trial was recruitment/retention over 12 months.

  Strategies used to facilitate recruitment/retention of this study

  population included engaging pre-trial multi-level stakeholders,

  selecting trial sites with high percentages of underserved children and

  families, training diverse medical providers to recruit participants,

  conducting remote trial assessments, and providing multi-lingual study

  materials.Results: Twenty-six children {[}42.3\% female, 11.5\% Black,

  30.8\% Multiracial (Black \& other), 76.9\% Hispanic, and 92.3\% with

  family income below \$40,000] and their caregivers were enrolled in the

  study, which represents 55.3\% of those initially referred by their

  provider, with 96.2\%, 92.3\%, and 96.2\% retention at 3-, 6-, and 12

  -month follow-up, respectively.Conclusion: Targeted strategies

  facilitated the inclusion of a medically underserved population of

  children and families in our pilot study, prior to expanding to a larger

  trial.'
affiliation: 'O''Donoghue, J (Corresponding Author), S5-828,55 Lake Ave N, Worcester,
  MA 01655 USA.

  O''Donoghue, Julia; Hoque, Shushmita; Mizrahi, Raphael; Spano, Michelle; Trivedi,
  Michelle, Univ Massachusetts, Dept Pediat, Div Pulmonol, Chan Med Sch, Worcester,
  MA USA.

  Luther, Janki, Washington Univ, Dept Med, Sch Med, St Louis, MO USA.

  Crawford, Sybil, Univ Massachusetts, Dept Med, Chan Med Sch, Worcester, MA USA.

  Frisard, Christine; Lemon, Stephenie C.; Rosal, Milagros; Pbert, Lori; Trivedi,
  Michelle, Univ Massachusetts, Dept Populat \& Quantitat Hlth Sci, Chan Med Sch,
  Worcester, MA USA.

  Garg, Arvin, Univ Massachusetts, Dept Pediat, Chan Med Sch, Worcester, MA USA.

  Byatt, Nancy, Univ Massachusetts, Dept Psychiat, Chan Med Sch, Worcester, MA USA.

  O''Donoghue, Julia, S5-828,55 Lake Ave N, Worcester, MA 01655 USA.'
article-number: '106884'
author: O'Donoghue, Julia and Luther, Janki and Hoque, Shushmita and Mizrahi, Raphael
  and Spano, Michelle and Frisard, Christine and Garg, Arvin and Crawford, Sybil and
  Byatt, Nancy and Lemon, Stephenie C. and Rosal, Milagros and Pbert, Lori and Trivedi,
  Michelle
author-email: julia.odonoghue@spectrumhealth.org
author_list:
- family: O'Donoghue
  given: Julia
- family: Luther
  given: Janki
- family: Hoque
  given: Shushmita
- family: Mizrahi
  given: Raphael
- family: Spano
  given: Michelle
- family: Frisard
  given: Christine
- family: Garg
  given: Arvin
- family: Crawford
  given: Sybil
- family: Byatt
  given: Nancy
- family: Lemon
  given: Stephenie C.
- family: Rosal
  given: Milagros
- family: Pbert
  given: Lori
- family: Trivedi
  given: Michelle
da: '2023-09-28'
doi: 10.1016/j.cct.2022.106884
earlyaccessdate: AUG 2022
eissn: 1559-2030
files: []
issn: 1551-7144
journal: CONTEMPORARY CLINICAL TRIALS
keywords: Pilot test; Recruitment; Retention; Asthma; Clinical trials; Underserved
keywords-plus: POPULATIONS; OPPORTUNITIES; DISPARITIES; MINORITY; WOMEN; CARE
language: English
month: SEP
number-of-cited-references: '35'
papis_id: fe2358664d322863fdb5d8ca50764ddd
ref: Odonoghue2022strategiesimprove
times-cited: '1'
title: 'Strategies to improve the recruitment and retention of underserved children
  and families in clinical trials: A case example of a school-supervised asthma therapy
  pilot'
type: article
unique-id: WOS:000863129900001
usage-count-last-180-days: '1'
usage-count-since-2013: '1'
volume: '120'
web-of-science-categories: Medicine, Research \& Experimental; Pharmacology \& Pharmacy
year: '2022'