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Lessons Learned: Recruiting And Enrollment in CAM Trials

Lessons Learned: Recruiting And Enrollment in CAM Trials. Suzanna M. Zick ND MPH, Elena Gillespie, Keith Aaronson MD MS, Martin Stevens MD University of Michigan Complementary and Alternative Medicine Research Center. Objective.

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Lessons Learned: Recruiting And Enrollment in CAM Trials

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  1. Lessons Learned: Recruiting And Enrollment in CAM Trials Suzanna M. Zick ND MPH, Elena Gillespie, Keith Aaronson MD MS, Martin Stevens MD University of Michigan Complementary and Alternative Medicine Research Center

  2. Objective • To compare and contrast the unique aspects of recruiting and enrollment of patients in complementary and alternative medicine (CAM) trials compared to allopathic trials.

  3. Methods • Identified three allopathic (APC) trials with the same patient population(s) • Collected information on the(APC) trials • recruitment • enrollment • number of subjects who gave “no interest” as a reason for not wanting to be in the trial • Compared the APC numbers to the CAM numbers

  4. Herbal Therapy Vs. Energy Therapy

  5. Hawthorn Project • Congestive Heart Failure • Randomized, Double-blind, placebo controlled • Patients come for three visits over 6 months • Take two herbal caplets/day

  6. Reiki Project • Diabetic Neuropathy • Randomized, Double-blind, Placebo controlled • Energy Treatment • Patient receives twelve 1/2 hour treatments

  7. Eligibility CriteriaHawthorn

  8. 6-Minute Walk

  9. Eligibility CriteriaReiki

  10. HbA1c < 12%

  11. Results

  12. Results: Hawthorn • 88% of eligible patients decided to participate • 5% gave lack of interest as a reason for non-participation • SOLVD and MERIT-HF Trials • 54% of eligible patients decided to participate • 11% gave lack of interest as a reason for non-participation

  13. Results: Reiki • 90 % of eligible patients decided to participate • 1% gave lack of interest as a reason for non-participation • Michigan Diabetic Research and Training Center • 75% of eligible patients decided to participate • 11% gave lack of interest

  14. Reasons for Non-Participation Reiki • Travel Distance and Time 58% • Frequency of Visits 39% • Religious Beliefs 2%

  15. Reasons for Non-Participation Hawthorn • Travel Distance and Time 75% • Length of Visits 18% • Belief would affect • current medication 1% • Too Many Tests 1%

  16. Conclusions • Compared to trials using allopathic treatments in similar patient populations more patients choose to participate in CAM trials • Fewer people gave no interest as a reason not to participate in CAM trials • Different and unique reasons for non-participation

  17. Future Directions/Research • Why do patients choose to participate at higher rates in CAM trials? • Current popularity of CAM therapies • Perceptions of CAM as both safe and natural • Attention form individual caregivers

  18. Future Directions/Research • Finding ways to remove barriers to participation in CAM trials • Accurate identification and frequency of why patients do not participate • Devising strategies to minimize barriers to participation

  19. “I have not failed I have just found 10,000 ways that won’t work” Thomas Alva Edison (1847-1931)

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