HeartMapp: Assessment and Training for Heart Failure

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 Identifier: NCT03827954

Version 3 February 22, 2019

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TABLE OF CONTENTS

Page

STUDY TEAM ROSTER .........................................................................................................4

PR?CIS .....................................................................................................................................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

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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

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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

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PR?CIS

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 BHQ) by HF patients. ? Secondary objectives are: to test the initial efficacy of HeartMapp +BHQ to improve cognitive function and heart failure (HF) self-care. We will also explore the efficacy of HeartMapp to improve quality of life, global health, medication adherence, heart rate variability (HRV) and reducing hospital admissions.

Design and Outcomes We will conduct a prospective, parallel arm, double blinded, randomized, controlled pilot clinical trial to examine feasibility and initial efficacy of the HeartMapp +BHQ compared to an attention control condition who will use the CHF Info App +control games. Approximately 49 participants aged 40 and older with a diagnosis of HF, will be consented to ensure the successful completion of 40 participants (post ~18% attrition). Eligible participants will be randomized to either HeartMapp +BHQ or an active control condition using the CHF Info App +BHQ. Both groups will complete follow-up assessments at 3- and 6-months after enrollment.

? The primary outcome is the feasibility of using HeartMapp +BHQ, which will be quantified by measuring app usage and engagement with the apps. Engagement with CT of BHQ will be calculated as percentage of participant's who complete at least 20 hours of assigned CT included in HeartMapp. App feasibility and engagement will be assessed by App access by participants; Accessing App components at least 80% of the days (72 days out of 90-days) will be used to determine app engagement.

? The secondary outcomes are improvement in cognitive function and HF self-care. If we see effect sizes on Cohen's d of d=0.25 or greater relative to controls for these outcomes, HeartMapp will be considered potentially efficacious.

? Exploratory outcomes include improvement in quality of life, global health, medication adherence, HRV and hospital admission. We will calculate effect sizes using Cohen's d on these outcomes to inform future studies.

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