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Informed Consent FormTITLE: A Pragmatic Trial of HOme Based Selfmanagement & COgnitive Training CHanges Lives (HOBSCOTCH) in GeorgiaNCT NUMBER: NCT04639206IRB APPROVAL DATE: May 18, 2023IRB Approved
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Identify the key objective of the pragmatic trial.
02
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03
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04
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05
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Who needs title a pragmatic trial?

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04
Participants or patients considering enrollment.
05
Funding agencies assessing the relevance of the trial.
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A Title A pragmatic trial is a type of clinical study designed to evaluate the effectiveness of an intervention in real-world settings, focusing on practical outcomes.
Researchers or institutions conducting pragmatic trials must file a Title A pragmatic trial.
Filling out a Title A pragmatic trial typically involves providing detailed information about the study design, methodology, objectives, and compliance with ethical standards.
The purpose of a Title A pragmatic trial is to assess the effectiveness of an intervention under routine conditions, thereby providing evidence that is applicable to everyday practice.
Key information to report includes trial objectives, methodology, participant demographics, treatment details, outcome measures, and data analysis plans.
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2023 2022 georgia hobscotch irb grady mod0011 study00000913 escoffery katie bullinger hipaa cdc waitlist phd epileptologist inperson edu nct nct04639206 3month ches rollins clinicaltrials funder funders deidentified dartmouth hitchcock researchgmh portabi

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