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Group 5 Clinical Trial

Group 5 Clinical Trial. Kirstie Campbell,

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Group 5 Clinical Trial

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  1. 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.

  2. 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 What we LEARNED and want to tell others (L) Design and create an educational intervention

  3. 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?

  4. 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

  5. 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 you’re 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

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

  7. 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.

  8. 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/default.aspx

  9. HSTA’s SSTA’s and MSTA’s=) Learning How To Develop An Implement. A Clinical Trial.

  10. Prototype of Clinical and Translational Research Study Outcome Outcome NoIntervention Study History Baseline Evaluation Time Intervention • Subject Intensive Description • Ŧ family history • Ŧ personal history • Ŧ measures of nutrition, exercise, obesity, and risk of diabetes Subject Accrual Interval endpoint measurement of selected variables Ŧ feasible measurements for study in community

  11. *~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

  12. 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.

  13. We practiced taking a base line survey. And created a new survey to be used.

  14. Intervention... Coming Soon!!!

  15. Post Evaluation…

  16. 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

  17. 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 Least…WVU! Special Thanks to: Cathy Morton, Delores Fondale

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