Group 5 Clinical Trial

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Group 5Clinical Trial

• Kirstie Campbell,
• Stephanie Hutchinson, Blaire Williams, Miranda
  Shaner, Billy Heath, Chris Payne, Chris Simmons,
  Brandon Abbott, Nick Gordon, Rachae Graves, Josh
  Jackson, Anna Sampson, Stephanie Kelly, Sara
  Catlett, Marquiesha Hairston, Michaela Yoak,
  Thomas Gray, Jzanese Weekes, Zac Atwell, Courtney
  Handley, Samantha Simmons, Shannon Tolen, Darryl
  Baynes, Craig Arensberg.

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• Hypothesis (Question)
• Does a better understanding of risk factors for
  obesity and diabetes lead to a change in behavior
  to avoid these risk factors?
• This can be broken down into a structured
  framework using KWLH approach
• What we KNOW (K)
• role of diet and
  exercise in energy \
• metabolism
• obesity
• diabetes
• treatment of diabetes
• What we WANT to find out (W)
• role in diet and
  exercise in energy
• metabolism
• obesity
• diabetes
• treatment of diabetes

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• HOW do we know if this new information made any
  difference (H)
• Design how the intervention will be implemented
• Design a study to find out if the new information
  made a difference
• a) Who to study?
• b) How many to study?
• c) What measurements to make in the study?
• Analysis of results from study
• a) How can the results be best presented to
  the community?
• b) Could design be improved?
• Does the study raise new questions that can be
  answered by another study?

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Ethics, Morals, and HIPAA.

• Ethics- Do no harm, respect for persons, justice,
  and beneficent.
• Morals- To set standards and live by them.
• HIPAA- Health Insurance Portability
  Accountability Act

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Survey On Diabetes

• On Tuesday we broke up into two groups and ask
  questions to our BioMed peers. These are some of
  the questions
• 1. Do you have diabetes?
• 2. Do either one of your parents have diabetes?
• 3. Do any of your siblings have diabetes?
• 4. Does any other of your family members have
  diabetes?
• 5. Do any of your peers have diabetes?
• 6. Have you ever been tested for diabetes?
• 7. Do you think your present eating habits will
  lead to diabetes?
• 8. Do you exercise enough to prevent diabetes?
• 9. Do you feel that youre at a healthy weight?
  Y/N/U
• 10. Do you know the symptoms of diabetes?
• Count how many people are in the room
• Count of males/females
• Count yes/no

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Family Tree
This is an example of how we did our family tree.
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Consent Form

• We made our own consent form for our Clinical
  Trial. We learned that you have word things
  exactly right and make questions very clear.

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Thank You PITT!!!

• Thanks to the Team from PITT we have
• Our own Group 5 website where we can discuss
  issues, upload documents keep in touch as we
  work on our Clinical Trials/Symposium Projects.
• Our own webcams we can use to communicate with
  our group members across the state and Pittsburgh
• https//ccp-236.dept-med.pitt.edu/hstasummer/defau
  lt.aspx

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HSTAs SSTAs and MSTAs )

• Learning How To Develop An Implement. A Clinical
  Trial.

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Prototype of Clinical and Translational Research
Study
Outcome Outcome
No Intervention
Study History
Baseline Evaluation
Time
Intervention
Subject Intensive Description T family
history T personal history T measures of
nutrition, exercise, obesity, and risk of
diabetes
Subject Accrual
Interval endpoint measurement of selected
variables
T feasible measurements for study in community
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Creating A Clinical Trial

• Study The Subject That Is Being Used
• Complete a Consent Form
• Take a baseline survey
• Apply An Intervention and a control
• Post Evaluation
• Analyze The Results
• Publish Results

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We constructed our own consent form

• CERTIFICATION of INFORMED CONSENT
• I certify that I have explained the nature and
  purpose of this research study to the above-named
  individual(s), and I have discussed the potential
  benefits and possible risks of study
  participation. Any questions the individual(s)
  have about this study have been answered, and we
  will always be available to address future
  questions as they arise.
• ___________________________________ _____________
  ___________
• Printed Name of Person Obtaining Consent Role in
  Research Study
• _________________________________ ____________
  
• Signature of Person Obtaining Consent Date
• IF THE RESEARCH STUDY INVOLVES CHILDREN, PLEASE
  SEE CHAPTER 8.0, SECTION 8.2 14 FOR THE
  APPROPRIATE LANGUAGE/SIGNATURE SPACES.

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We practiced taking a base line survey.
And created a new survey to be used.
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Intervention...
Coming Soon!!!
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Post Evaluation
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Future Events!!

• Send Data and Travel to Pittsburgh to Analyze the
  results
• Use results for symposium
• Results published in a medical educational
  journal
• Present our clinical trial at the Spring National
  Institute of Health/ SEPA meeting

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The End
Thanks To Dr. Branch, Steve Groark, Louise
DeRiso, Dr Shama Buch, University of Pittsburgh,
Dr. Chester, Dr. Dooley, Jenny Bardwell, And Last
But Not LeastWVU!
Special Thanks to Cathy Morton, Delores Fondale