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Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial.

Publication ,  Journal Article
Beckie, TM; Mendonca, MA; Fletcher, GF; Schocken, DD; Evans, ME; Banks, SM
Published in: J Cardiopulm Rehabil Prev
2009

PURPOSE: To examine the challenges of recruiting women for a 5-year cardiac rehabilitation randomized clinical trial; the aims of the study were to describe the range of recruitment sources, examine the myriad of factors contributing to ineligibility and nonparticipation of women during protocol screening, and discuss the challenges of enrolling women in the trial. METHODS: The Women's-Only Phase II Cardiac Rehabilitation program used an experimental design with 2 treatment groups. Eligible participants included women who were (1) diagnosed with a myocardial infarction or stable angina or had undergone coronary revascularization within the last 12 months; (2) able to read, write, and speak English; and (3) older than 21 years. Responses to multiple recruitment strategies including automatic hospital referrals, physician office referrals, mass mailings, media advertisements, and community outreach are described. Reasons for ineligibility and nonparticipation in the trial are explored. RESULTS: Automatic hospital order was the largest source of referral (n = 1,367, 81%) accounting for the highest enrollment rate of women (n = 184, 73%). The barriers to enrollment into the cardiac rehabilitation clinical trial included patient-oriented, provider-oriented, and programmatic factors. Of the referral sources, 52% were screened ineligible for provider-oriented reasons, 31% were ineligible due to patient-oriented factors, and 17.4% were linked to the study protocol. Study nonparticipation of those eligible (73.8%) was largely associated with patient-oriented factors (65.2%), with far less due to provider-related factors (4%) or study-related factors (3.4%). CONCLUSION: Standing hospital orders facilitated enrollment to the cardiac rehabilitation clinical trial, yet women failed to participate predominantly due to significant patient-oriented biopsychosocial barriers.

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Published In

J Cardiopulm Rehabil Prev

DOI

ISSN

1932-7501

Publication Date

2009

Volume

29

Issue

1

Start / End Page

13 / 21

Location

United States

Related Subject Headings

  • Patient Selection
  • Patient Participation
  • Humans
  • Health Knowledge, Attitudes, Practice
  • Female
  • Coronary Artery Disease
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • 4201 Allied health and rehabilitation science
  • 3201 Cardiovascular medicine and haematology
 

Citation

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ICMJE
MLA
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Beckie, T. M., Mendonca, M. A., Fletcher, G. F., Schocken, D. D., Evans, M. E., & Banks, S. M. (2009). Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial. J Cardiopulm Rehabil Prev, 29(1), 13–21. https://doi.org/10.1097/HCR.0b013e31819276cb
Beckie, Theresa M., Mary Ann Mendonca, Gerald F. Fletcher, Douglas D. Schocken, Mary E. Evans, and Steven M. Banks. “Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial.J Cardiopulm Rehabil Prev 29, no. 1 (2009): 13–21. https://doi.org/10.1097/HCR.0b013e31819276cb.
Beckie TM, Mendonca MA, Fletcher GF, Schocken DD, Evans ME, Banks SM. Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial. J Cardiopulm Rehabil Prev. 2009;29(1):13–21.
Beckie, Theresa M., et al. “Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial.J Cardiopulm Rehabil Prev, vol. 29, no. 1, 2009, pp. 13–21. Pubmed, doi:10.1097/HCR.0b013e31819276cb.
Beckie TM, Mendonca MA, Fletcher GF, Schocken DD, Evans ME, Banks SM. Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial. J Cardiopulm Rehabil Prev. 2009;29(1):13–21.

Published In

J Cardiopulm Rehabil Prev

DOI

ISSN

1932-7501

Publication Date

2009

Volume

29

Issue

1

Start / End Page

13 / 21

Location

United States

Related Subject Headings

  • Patient Selection
  • Patient Participation
  • Humans
  • Health Knowledge, Attitudes, Practice
  • Female
  • Coronary Artery Disease
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • 4201 Allied health and rehabilitation science
  • 3201 Cardiovascular medicine and haematology