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American Public Health Association
133rd Annual Meeting & Exposition
December 10-14, 2005
Philadelphia, PA
APHA 2005
3077.0: Monday, December 12, 2005 - 11:10 AM

Abstract #108176

Patient recruitment to a phase III complementary and alternative medicine clinical trial: Overcoming challenges

Alyssa Cotler, MPH1, Jacqueline Arciniega, MPH2, Lynne Doner, MA3, Amy Lange4, Irene Liu, MPH, CHES1, Richard Nahin, PhD, MPH5, Jennifer Tisch, MPH1, Gervasio Lamas, MD2, Lindsay Lambe, BA, CNMT6, and Nancy Clapp-Channing, MPH6. (1) Office of Communications and Public Liaison, National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH), Building 31, Room 2B11, Bethesda, MD 20892-2182, 301-451-3851, cotlera@mail.nih.gov, (2) Cardiology Research, Mount Sinai Medical Center, 4300 Alton Road, Butler Building, Miami Beach, FL 33140, (3) Lynne Doner Consulting, 6417 North 19th Street, Arlington, VA 22205, (4) GYMR, LLC, 1825 Connecticut Ave, NW, Suite 300, Washington, DC, DC 20009, (5) Office of the Director, National Center for Complementary and Alternative Medicine (NCCAM), NIH, 6707 Democracy Blvd, Suite 400, Bethesda, MD 20892-5475, (6) Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715

Patient recruitment to clinical studies of unconventional practices poses unique challenges: many treatments are already in widespread use, and many consumers and their physicians have strong—and often opposing—views regarding the use of CAM. A key case study is the Trial to Assess Chelation Therapy (TACT), sponsored by NCCAM and NHLBI, evaluating chelation therapy for the treatment of heart disease. TACT will require more than 2,300 patients, ages 50 and older with a prior heart attack. More than 100 clinical sites in the U.S. are participating. NCCAM took a methodical approach to developing and implementing a patient recruitment plan for TACT. To better understand the views of the target audience and to help develop salient messages, materials, and outreach strategies, NCCAM conducted focus groups with people representative of the study's patient population in the Washington, D.C. area. Participants also provided insight into perceived benefits and drawbacks of participating in the study. These data informed the development of a multifaceted communications plan that focused on two primary strategies: 1) Equipping and training the research sites to develop and implement customized recruitment plans, including customized plans for securing media coverage; and 2) Conducting centralized national recruitment. The presentation will include findings from the focus groups, discuss the process of developing a patient recruitment program, show promotional materials, and share evaluation data of our efforts, including media coverage, inquiries to the NCCAM clearinghouse (including how callers learned about the study), and numbers of people enrolled in the study.

Learning Objectives:

  • At the conclusion of the session, the participant will be able to

    Keywords: Clinical Trials, Alternative Medicine/Therapies

    Related Web page: nccam.nih.gov/chelation/

    Presenting author's disclosure statement:

    I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.

    [ Recorded presentation ] Recorded presentation

    Evidence Based Alternative and Complementary Health Practices and Policies

    The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA