REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
Phase: NA
Conditions: Ischemic Heart Disease
Sponsor: NYU Langone Health

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Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................................. II 
LIST OF ABBREVIATIONS ........................................................................................................................ VI 
PROTOCOL SUMMARY .............................................................................................................................. 7 
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 8 
1 
KEY ROLES ......................................................................................................................................... 9 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ..................... 10 
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2.3.1 
Known Potential Risks ........................................................................................................... 11 
2.3.2 
Known Potential Benefits ...................................................................................................... 12 
3 
OBJECTIVES AND PURPOSE ......................................................................................................... 13 
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4 
STUDY DESIGN AND ENDPOINTS ................................................................................................. 13 
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4.2.1 
Primary Study Endpoints ....................................................................................................... 13 
4.2.2 
Secondary Study Endpoints .................................................................................................. 14 
4.2.3 
Exploratory Endpoints ........................................................................................................... 15 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................. 15 
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5.4.1 
Use of Epic Information for Recruitment Purposes ............................................................... 17 
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5.7.1 
Reasons for Withdrawal or Termination ................................................................................ 18 
5.7.2 
Handling of Participant Withdrawals or Termination ............................................................. 19 
5.7.3 
Premature Termination or Suspension of Study ................................................................... 19 
6 
BEHAVIORAL/SOCIAL INTERVENTION ......................................................................................... 19 
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6.1.1 
Administration of Intervention ................................................................................................ 19 
6.1.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity ................... 20 
6.1.3 
Assessment of Subject Compliance with Study Intervention ................................................ 21 
7 
STUDY PROCEDURES AND SCHEDULE ....................................................................................... 22 
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7.1.1 
Study Specific Procedures .................................................................................................... 22 
7.1.2 
Standard of Care Study Procedures ..................................................................................... 25 
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7.2.1 
Screening .............................................................................................................................. 25 
7.2.2 
Enrollment/Baseline .............................................................................................................. 26 
7.2.3 
Intermediate Visits ................................................................................................................. 27 

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7.2.4 
Final Study Visit ..................................................................................................................... 27 
7.2.5 
Withdrawal/Early Termination Visit ........................................................................................ 27 
7.2.6 
Unscheduled Visit .................................................................................................................. 27 
8 
ASSESSMENT OF SAFETY ............................................................................................................. 27 
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8.1.1 
Definition of Adverse Events (AE) ......................................................................................... 27 
8.1.2 
Definition of Serious Adverse Events (SAE) ......................................................................... 28 
8.1.3 
Definition of Unanticipated Problems (UP) ............................................................................ 28 
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8.2.1 
Severity of Event ................................................................................................................... 28 
8.2.2 
Relationship to Study Intervention ......................................................................................... 29 
8.2.3 
Expectedness ........................................................................................................................ 29 
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8.4.1 
Adverse Event Reporting ...................................................................................................... 30 
8.4.2 
Serious Adverse Event Reporting ......................................................................................... 30 
8.4.3 
Unanticipated Problem Reporting ......................................................................................... 30 
8.4.4 
Reporting of Pregnancy ......................................................................................................... 31 
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8.8.1 
Events/Data to be Reviewed by DSMB ................................................................................. 32 
8.8.2 
Pre-Specified Stopping Rules ............................................................................................... 32 
8.8.3 
Dissemination of Decision by DSMB ..................................................................................... 33 
9 
CLINICAL MONITORING .................................................................................................................. 33 
10 
STATISTICAL CONSIDERATIONS .................................................................................................. 33 
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10.4.1 
General Approach ............................................................................................................. 34 
10.4.2 
Analysis of the Primary Efficacy Endpoint(s) .................................................................... 34 
10.4.3 
Analysis of the Secondary Endpoint(s) ............................................................................. 35 
10.4.4 
Safety Analyses ................................................................................................................ 35 
10.4.5 
Adherence and Retention Analyses.................................................................................. 36 
10.4.6 
Baseline Descriptive Statistics .......................................................................................... 37 
10.4.7 
Planned Interim Analysis................................................................................................... 37 
10.4.8 
Additional Sub-Group Analyses ........................................................................................ 37 
10.4.9 
Multiple Comparison/Multiplicity ........................................................................................ 37 
10.4.10 
Tabulation of Individual Response Data ........................................................................... 37 
10.4.11 
Exploratory Analyses ........................................................................................................ 37 
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10.6.1 
Enrollment/Randomization/Masking Procedures .............................................................. 39 
10.6.2 
Evaluation of Success of Blinding ..................................................................................... 40 
10.6.3 
Breaking the Study Blind/Participant Code ....................................................................... 40 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 40 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ....................................................................... 40 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 41 
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13.3.1 
Consent/Assent and Other Informational Documents Provided to Participants ............... 41 
13.3.2 
Consent Procedures and Documentation ......................................................................... 41 
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Research Use of Stored Human Samples, Specimens, or Data ...................................... 43 
14 
DATA HANDLING AND RECORD KEEPING ................................................................................... 43 
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STUDY FINANCES ............................................................................................................................ 45 
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STUDY ADMINISTRATION ............................................................................................................... 45 
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CONFLICT OF INTEREST POLICY .................................................................................................. 46 
18 
REFERENCES ................................................................................................................................... 46 
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ATTACHMENTS ................................................................................................................................ 53 

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1 Key Roles 
 
John A. Dodson, MD, MPH – Principal Investigator 
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Kevin P. Marzo, MD – Sub-Investigator 
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Barbara J. George EdD, RCEP, MSN, AGNP-C – Sub-Investigator 
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Samrachana Adhikari, PhD –Co-Investigator, Biostatistician 
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Patrick Xin – Data Management, NYU DataCore 
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Caroline Blaum, MD, MS – Co-Investigator 
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Antoinette Schoenthaler, EdD – Co-Investigator 
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Judith S. Hochman, MD – Co-Investigator 
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Sarwat Chaudhry, MD—Yale Site Principal Investigator 
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Thomas Gill, MD –Yale Site Co-Investigator 
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Lee Jennings, MD, MSHS –Consultant, Goal Attainment Scaling 
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JP Pollak, PhD –Consultant, Computer Science 
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Lara Kovell, MD – UMMHC Site Principal Investigator 
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2 Introduction, Background Information and Scientific Rationale 
2.1 
Background Information and Relevant Literature 
 
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2.3 
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2.3.1 
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2.3.2 
Known Potential Benefits 
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3 Objectives and Purpose 
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3.1 
Primary Objective 
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3.2 
Secondary Objectives 
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4 Study Design and Endpoints 
4.1 
Description of Study Design 
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4.2 
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4.2.1 
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4.2.2 
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4.2.3 
Exploratory Endpoints 
 
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5 Study Enrollment and Withdrawal 
5.1 
Inclusion Criteria 
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5.2 
Exclusion Criteria 
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Vulnerable Subjects 
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5.5 
Duration of Study Participation 
 
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Total Number of Participants and Sites 
 
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5.7 
Participant Withdrawal or Termination 
 
5.7.1 
Reasons for Withdrawal or Termination 
 
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Handling of Participant Withdrawals or Termination 
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Premature Termination or Suspension of Study 
 
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6 Behavioral/Social Intervention 
6.1 
Study Behavioral or Social Intervention(s) Description 
 
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6.1.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
 
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6.1.3 
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Intermediate Visits 
 
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Final Study Visit 
 
3- month Ambulatory Visit (Visit 2, Day 90 +30 days) 
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Unscheduled Visit 
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8 Assessment of Safety 
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Specification of Safety Parameters 
 
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Definition of Serious Adverse Events (SAE) 
 
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8.1.3 
Definition of Unanticipated Problems (UP) 
 
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Classification of an Adverse Event 
 
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Severity of Event 
 
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8.2.2 
Relationship to Study Intervention 
 
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x Probably Related ±7KHUHLVHYLGHQFHWRVXJJHVWDFDXVDOUHODWLRQVKLSDQGWKHLQIOXHQFHRIRWKHU
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8.2.3 
Expectedness 
 
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8.3 
Time Period and Frequency for Event Assessment and Follow-Up 
 
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8.4 
Reporting Procedures – Notifying the IRB 
 
8.4.1 
Adverse Event Reporting 
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Serious Adverse Event Reporting 
 
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8.4.3 
Unanticipated Problem Reporting 
 
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8.4.4 
Reporting of Pregnancy 
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8.5 
Reporting Procedures – Notifying the Study Sponsor 
 
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8.6 
Reporting Procedures – Participating Investigators 
 
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8.7 
Study Halting Rules 
 
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8.8 
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9 Clinical Monitoring 
 
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10 Statistical Considerations 
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Primary Endpoints 
 
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10.4 Description of Statistical Methods 
 
10.4.1 General Approach 
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10.4.2 Analysis of the Primary Efficacy Endpoint(s) 
 
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10.4.3 Analysis of the Secondary Endpoint(s) 
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10.4.4 Safety Analyses 
 
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10.4.5 Adherence and Retention Analyses 
 
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10.4.6 Baseline Descriptive Statistics 
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10.4.7 Planned Interim Analysis 
 
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10.4.7.1 Safety Review 
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10.4.8 Additional Sub-Group Analyses 
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10.4.10 Tabulation of Individual Response Data 
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10.6.1 Enrollment/Randomization/Masking Procedures 
 
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14.1 Data Collection and Management Responsibilities 
 
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15 Study Finances 
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16 Study Administration 
16.1 Study Leadership 
 
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18 References 
 
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