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Assessment and Training for Heart Failure Heartmapp

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Assessment and Training for Heart Failure Heartmapp HeartMapp: Assessment and Training for Heart Failure HeartMapp: A Closed-Loop Assessment and Treatment Mobile Application for Heart Failure. A Pilot Randomized Clinical Trial Principal Investigator Ponrathi Athilingam, PhD, RN, ARNP Associate Professor University of South Florida, College of Nursing Supported by: The National Institute of Nursing Research R43NR018415-01 ClinicalTrials.gov Identifier: NCT03827954 Version 3 February 22, 2019 HeartMapp Protocol, Version 3 Page i of 54 TABLE OF CONTENTS Page STUDY TEAM ROSTER ......................................................................................................... 4 PRÉCIS ..................................................................................................................................... 5 1. Study objectives ................................................................................................................. 7 1.1 Primary Objective ........................................................................................................... 7 1.2 Secondary Objectives .................................................................................................... 7 1.2a Exploratory Objective .................................................................................................. 7 1.3 Background ..................................................................................................................... 7 1.4 Study Rationale .............................................................................................................. 8 2. STUDY DESIGN ................................................................................................................. 11 3. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 12 3.1 Exclusion Criteria ......................................................................................................... 13 3.2 Study Enrollment Procedures ..................................................................................... 15 4. STUDY INTERVENTIONS ................................................................................................ 16 4.1 Interventions, Administration, and Duration .............................................................. 20 4.2 Handling of Study Interventions .................................................................................. 22 4.2.1 Allowed Interventions ...................................................................................... 22 4.2.2 Required Interventions .................................................................................... 23 4.2.3 Prohibited Interventions .................................................................................. 23 4.3 Adherence Assessment............................................................................................... 23 5. STUDY PROCEDURES .................................................................................................... 23 5.2 Description of Evaluations ........................................................................................... 28 5.2.1 Enrollment, Baseline, and/or Randomization .......................................... 31 5.2.2 Follow-up Visits ............................................................................................... 32 5.2.3 Retention .......................................................................................................... 32 6. SAFETY ASSESSMENTS ................................................................................................ 33 6.1 Adverse Events and Serious Adverse Events........................................................... 37 HeartMapp Protocol, Version 3 ii February 22, 2019 Pro00038118 6.2 Reporting Procedures .................................................................................................. 38 6.3 Follow-up for Adverse Events ..................................................................................... 38 6.4 Safety Monitoring ......................................................................................................... 38 7. INTERVENTION DISCONTINUATION ............................................................................ 39 8. STATISTICAL CONSIDERATIONS................................................................................. 40 8.1 General Design Issues ................................................................................................ 40 8.2 Sample Size.................................................................................................................. 40 8.2.1 Treatment Assignment Procedures ................................................................ 41 8.2.2 Interim analyses and Stopping Rules ............................................................. 41 8.3 Outcomes ...................................................................................................................... 41 8.3.1 Primary outcome ............................................................................................. 41 8.3.2 Secondary outcomes ...................................................................................... 42 8.3.3 Exploratory outcomes ..................................................................................... 42 8.4 Data Analysis ................................................................................................................ 42 9. DATA COLLECTION AND QUALITY ASSURANCE .................................................... 43 9.1 Data Collection Forms ................................................................................................. 43 9.2 Data Management ....................................................................................................... 44 9.3 Quality Assurance ........................................................................................................ 45 9.3.1 Training ............................................................................................................ 45 9.3.2 Quality Control Committee ............................................................................. 46 9.3.3 Protocol Deviations ......................................................................................... 46 9.3.4 Monitoring ........................................................................................................ 46 10. PARTICIPANT RIGHTS AND CONFIDENTIALITY ..................................................... 46 10.1 Institutional Review Board (IRB) Review ................................................................. 46 10.2 Informed Consent Forms .......................................................................................... 46 10.3 Participant Confidentiality .......................................................................................... 47 10.4 Study Discontinuation ................................................................................................ 47 11. COMMITTEES .................................................................................................................. 47 12. REFERENCES ................................................................................................................. 48 13. SUPPLEMENTS/APPENDICES ..................................................................................... 54 13.1 Modifications............................................................................................................... 54 HeartMapp Protocol, Version 3 iii February 22, 2019 Pro00038118 STUDY TEAM ROSTER MAIN RECRUITMENT SITES USF Health Morsani Center for Advanced Healthcare 13330 USF Laurel Dr, Tampa, FL 33613 Telephone: 813-974-2201 Florida Hospital Tampa and the Pepin Heart Institute 3100 East Fletcher Avenue Tampa, Florida 33613 Telephone: 813-971-6000 Florida Cardiology Division of USF 509 S Armenia Ave #200, Tampa, FL 33609 PRINCIPAL INVESTIGATOR (Site PI) Ponrathi Athilingam, PhD, RN, ARNP CO-INVESTIGATORS Miguel Labrador, PhD, Professor, Department of Computer Science and Engineering Jerri Edwards PhD, Professor, Department of Psychiatry and Behavioral Neurosciences Joel Fernandez, MD, FACC, Assistant Professor, USF Cardiology, and Florida Cardiology Division at S. Armenia Avenue, Tampa SPONSOR/PI on the Grant) Tom Van Vleet, PhD, Director of Sponsored Programs / Senior Scientist, Posit Science Inc. San Francisco, CA OTHER STUDY STAFF Aimon C. Miranda, PharmD, BCPS, Assistant Professor, Department of Pharmacotherapeutics and Clinical Research, USF, College of Pharmacy Kristen Dolan, ARNP, Florida Hospital, Tampa TBD. Study coordinator and Research Assistants, USF College of Nursing HeartMapp Protocol, Version 3 4 February 22, 2019 Pro00038118 PRÉCIS Short Study Title HeartMapp: Assessment and Treatment for Heart Failure Full Study Title HeartMapp: A Closed-Loop Assessment and Treatment Mobile Application for Heart Failure: A Randomized Clinical Trial Aims/ Objectives Development Phase (Project months 0-3) During the development phase, the team will finalize the cognitive training (CT) modules from BrainHQ (BHQ) of Posit Science Corporation within HeartMapp, complete the software development and release the app through the quality management system. Feasibility and Efficacy Testing Phase (Project months 4-12) • Primary objective is to establish the feasibility of the HeartMapp Plus [+] CT from BrainHQ. Feasibility will be assessed by App usage and engagement (HeartMapp + BHQ and CHF (Congestive Heart Failure) Info App + control games from
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