Technology: Utilizing Mobile Applications

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Technology: Utilizing Mobile Applications

  1. 1. INTRODUCTIONEmily Abbott JD, CPAMonitor and coordinate the financial management of theATACH-II Clinical Trial for which cumulative funding awarded bythe National Institutes of Health is projected at $23 million. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  2. 2. AGENDA• Background of ATACH-II Clinical Trial• General Barriers to Recruitment in Clinical Research• Incorporation of a Mobile Application ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  3. 3. ATACH-II CLINCAL TRIAL BACKGROUND• Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II).• A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage.• Funded by the National Institutes of Health for 5 years with a recruitment goal of 1,280 subjects. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  4. 4. ATACH-II CLINICAL COORDINATING CENTER• The ATACH-II Clinical Coordinating Center at the University of Minnesota manages all clinical sites screening for patients for the trial.• Clinical sites located in the United States, Japan, China, Taiwan, South Korea, and Germany.• Future sites in Brazil, Canada, and other European countries.• Approximately 125 domestic and foreign clinical sites. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. 5
  5. 5. ATACH-II HYPOTHESIS• Hypothesis •Intensive systolic blood pressure (SBP) reduction using intravenous (IV) nicardipine with treatment initiated within 4.5 hours of onset of ICH and continued for the next 24 hours reduces the likelihood of death or disability at three (3) months after ICH by ten percent (10%) or greater compared with standard SBP reduction. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  6. 6. PUBLIC POLICY• The trial will have important public health implications as it will provide necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension in subjects with ICH.• BP treatment represents a strategy that can be made widely available without the need of specialized equipment and personnel, and therefore can make a major impact upon outcome in patients with ICH. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  7. 7. BARRIERS TO RECRUITMENTMost common recruitment barriers:• EMS / ED arrival time is after the allowable time window for randomization *• Inability to obtain consent within the allowable time window for randomization* Time window is 4.5 hours from symptom onset ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  8. 8. ADDITIONAL BARRIERS TO RECRUITMENTBarrier to recruitment is heightened by multiple competing interests for patients within the Emergency Department:• Emergency Department is a difficult setting for referencing source documentation.• Initiation of patient to the trial through a web-based system may be difficult due to competing demands for equipment.• Time-Sensitive Availability of Research Team. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  9. 9. INTRODUCE MOBILE APPLICATION FOR TRIAL• The trial has incorporated the use of a mobile application to facilitate subject enrollment for the trial.• The ATACH-II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment Guidelines mobile application available on iPhone, Android, and Blackberry in 2011.• This mobile application allows screening and randomization through iPhone, Android, and Blackberry. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  10. 10. DESIGN ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  11. 11. DESIGN ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  12. 12. DESIGN ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  13. 13. ATACH-II MOBILE APPLICATION• This mobile application allows screening and randomization through iPhone, Android, and Blackberry. Not only has this application been widely adopted among investigators, other time sensitive clinical trials have adopted similar applications. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #
  14. 14. CONCLUSION Questions or Comments – Thank you. ©2012 MOBCON ─ WHERE MOBILE MINDS CONNNECT. ALL RIGHTS RESERVED. #

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