technology: utilizing mobile applications

INTRODUCTION

Emily Abbott JD, CPA

Monitor and coordinate the financial management of the

ATACH-II Clinical Trial for which cumulative funding awarded by

the National Institutes of Health is projected at $23 million.

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AGENDA

• Background of ATACH-II Clinical Trial

• General Barriers to Recruitment in Clinical Research

• Incorporation of a Mobile Application


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.


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.

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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.


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.


BARRIERS TO RECRUITMENT

Most 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


ADDITIONAL BARRIERS TO RECRUITMENT

Barrier 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.


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.


DESIGN


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.

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CONCLUSION

Questions or Comments – Thank you.


technology: utilizing mobile applications

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