Lessons Learned: Recruiting And Enrollment in CAM Trials

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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

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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.

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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

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Herbal Therapy Vs. Energy Therapy
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Hawthorn Project

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

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Reiki Project

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

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Eligibility CriteriaHawthorn
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6-Minute Walk
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Eligibility CriteriaReiki
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HbA1c lt 12
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Results
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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

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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

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Reasons for Non-Participation Reiki

• Travel Distance and Time 58
• Frequency of Visits 39
• Religious Beliefs 2

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Reasons for Non-Participation Hawthorn

• Travel Distance and Time 75
• Length of Visits 18
• Belief would affect
• current medication 1
• Too Many Tests 1

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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

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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

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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

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I have not failed I have just found 10,000 ways
that wont work

• Thomas Alva Edison (1847-1931)