i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Phase: NA
Conditions: Type2 Diabetes
Sponsor: NYU Langone Health

Official Title: 
i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-
reported Data Into Diabetes Management  
NCT Number:
NCT03652389
Study Number:
18-01044 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
January 22, 2021 

CLINICAL STUDY PROTOCOL 
 
 
 
i-Matter: Investigating an mHealth texting 
tool for embedding patient-reported data 
into diabetes management 
Study Number 
s18-01044 
Sponsors 
Agency for Healthcare Quality and Research 
5600 Fishers Lane, Rockville, MD, United States 
Merck & Co., Inc. 
Kenilworth NJ United States

Kenilworth, NJ. United States
Protocol Version 
January 5, 2021 
version 10 
 
 
 
 
 
 

Study Number s18-01044 
March 17, 2020 - version 9
Study Personnel 
Principal Investigator 
Antoinette Schoenthaler
New York University
Email: Antoinette.Schoenthaler@nyumc.org
 
 
 

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Study Number s18-01044 
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Synopsis 
Primary Objective 
To compare the efficacy of MJS DIABETES vs. usual care (UC) on HbA1c reduction at 
12-months. 
Secondary Objectives (if applicable)
1. To compare the efficacy of MJS DIABETES vs. UC on adherence to self-care 
behaviors. 
2. To evaluate the potential mediators of the intervention effects (diabetes 
knowledge, self-efficacy, outcome expectation, and patient-provider 
communication) on adherence to self-care behaviors and HbA1c reduction. 
Primary Outcome Variables
The primary outcome, mean reduction in levels of HbA1c, will be extracted from patients' 
medical records.  
Secondary and Exploratory Outcome Variables (if applicable) 
The secondary outcomes are: 1) adherence to self-care behaviors (assessed with the 
Summary of Diabetes Self-Care Activities questionnaire) and 2) the theoretical mediators 

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of capability (assessed with the diabetes knowledge scale), motivation (assessed with the 
diabetes self-efficacy and outcomes expectations scales) and opportunity (assessed with 
the Interpersonal Processes of Care survey).  
Study Duration 
The study duration is 5 years. The formative phase will be 12 months and the clinical 
efficacy trial will be the remaining 4 years.  Participants enrolled in the clinical efficacy trial 
will participate in the trial for 12 months. The approximate start date for the trial is 
September 1, 2018 and the approximate end date is August 31, 2023. 
Study Design 
Using a mixed-methods design, the proposed study will be conducted in two phases: 1) A 
formative phase, based on user-centered design and 2) a clinical-efficacy phase.  
For the formative phase, we will use a mixed methods observational design to refine the 
study intervention. 
For the clinical efficacy phase, we will conduct a single-blinded, phase 3 randomized 
controlled trial.  
Study Population 

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The study population will include primary care providers and patients with uncontrolled 
type 2 diabetes (T2D) receiving care in the network of Family Health Centers (FHCs) and 
Faculty Group Practices (FGPs) at NYU Langone Health. 
PCP Eligibility Criteria 
Inclusion Criteria: (a) Fulltime primary care provider (MD/DO, NP) practicing at the 
participating FHC and/or FGPs and (b) provides care to at least five patients with a 
diagnosis of T2D. 
Exclusion Criteria: Refuse to participate  
Patient Eligibility Criteria 
 Inclusion Criteria: 
 
 
 
 
 Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at 
 
 
 
 
 
 
 
 
 Be > 18 years of age. 
 Exclusion Criteria: 

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Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, 
renal transplantation, or other ESRD-related services documented in the 
 
 
Have significant psychiatric comorbidity or reports of substance abuse (as 
 
 
 
 
 
 
Plan to discontinue care at the clinic within the next 12 months. 
Number of Participants 
Formative Phase 
Patients: 36 patients with uncontrolled T2D 
Providers: 14 primary care providers 
Clinical Efficacy Trial [Sample includes new participants that did not participate in the 
formative phase] 
Patients: 282 patients with uncontrolled T2D 

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Providers:14 primary care providers
Abbreviations 
Abbreviation  
Explanation 
AHRQ 
Agency for Healthcare Research and Quality 
DSMP 
Data Safety Monitoring Plan 
EHR 
Electronic Health Record 
HbA1c 
Hemoglobin A1c 
mHealth 
Mobile Health 
MJS 
Modern Journal System 
NP 
Nurse Practitioner 

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PCP 
Primary Care Provider 
PHI 
Personal health information 
PI 
Principal Investigator 
PRO 
Patient-reported outcome 
RCT 
Randomized controlled trial 
SMBG 
Self-monitoring blood glucose 
T2D 
Type 2 diabetes 
TAM3 
Technology Acceptance Model-version 3 
UC 
Usual Care 
UCD 
User-centered design 
 
 

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Table of Contents 
1 - Introduction ...................................................................................................................... 9 
1.1 Introductory Statement ................................................................................................. 9 
2 - Background.................................................................................................................... 10 
2.1 Background/prevalence of research topic .................................................................. 10 
3 - Rationale/Significance ................................................................................................... 11 
3.1 Problem Statement .................................................................................................... 11 
3.2 Purpose of Study/Potential Impact ............................................................................. 11 
3.3.1 Potential Benefits ................................................................................................. 11 
3.3.2 Potential Risks ..................................................................................................... 12 
4 - Study Objectives .......................................................................................................... 155 
4.1 Hypothesis ............................................................................................................... 155 
4.2 Primary Objective ..................................................................................................... 155 
4.3 Secondary Objectives (if applicable) ........................................................................ 155 
5 - Study Design ............................................................................................................... 166 

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5.1 General Design........................................................................................................166
5.1.1 Study Duration (if applicable) ............................................................................. 166 
5.1.2 Number of Study Sites ....................................................................................... 176 
5.2.1 Primary Outcome Variables ................................................................................. 17 
5.2.2 Secondary and Exploratory Outcome Variables (if applicable) ........................... 177 
5.3 Study Population ...................................................................................................... 177 
5.3.1 Number of Participants ...................................................................................... 177 
5.3.2 Eligibility Criteria/Vulnerable Populations ........................................................... 188 
6 - Methods ......................................................................................................................... 19 
6.1.1 Description of Intervention ................................................................................... 19 
6.1.2 Method of Assignment/Randomization ................................................................. 25 
6.1.3 Selection of Instruments/Outcome Measures ....................................................... 26 
6.1.4 Intervention Administration ................................................................................ 305 
6.1.5 Reaction Management ......................................................................................... 30 
6.2.1 Efficacy ................................................................................................................ 30 
6.2.2 Safety/Pregnancy-related policy .......................................................................... 30 

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6.2.2.1 Adverse Events Definition and Reporting .......................................................... 30 
6.2.3 Pharmacokinetics (if applicable) .......................................................................... 31 
6.2.4 Biomarkers (if applicable) .................................................................................... 31 
6.3.1 Study Schedule ................................................................................................... 31 
6.3.2 Informed Consent .............................................................................................. 317 
6.3.3 Screening .......................................................................................................... 338 
6.3.4 Recruitment, Enrollment and Retention ............................................................. 338 
6.3.5 On Study Visits .................................................................................................... 30 
6.3.6 End of Study and Follow Up ................................................................................ 36 
6.4.2 Sample Size Considerations .............................................................................. 361 
6.4.3.1 Primary Analyses .............................................................................................. 37 
6.4.3.2 Secondary Objectives Analyses ........................................................................ 38 
6.4.3.3 Safety/Pregnancy-related policy ....................................................................... 39 
6.4.3.4 Analysis of Subject Characteristics ................................................................... 39 
6.4.3.5 Interim Analysis (if applicable) .......................................................................... 39 
6.4.3.6 Health economic evaluation .............................................................................. 39 

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6.4.5 Handling of Missing Data ..................................................................................... 39 
7 - Trial Administration ........................................................................................................ 40 
7.1 Ethical Considerations ............................................................................................... 40 
7.2 Institutional Review Board (IRB) Review .................................................................... 40 
7.3 Subject Confidentiality ............................................................................................... 40 
7.4 Deviations/Unanticipated Problems ........................................................................... 41 
7.5 Data Quality Assurance ............................................................................................. 42 
7.5.1 Data Collection .................................................................................................... 42
7.5.1.1 Access to Source .............................................................................................. 42 
7.5.1.2 Data Storage/Security ....................................................................................... 43 
7.6 Study Records ........................................................................................................... 43 
7.6.1 Retention of Records ........................................................................................... 43
7.7 Study Monitoring ........................................................................................................ 43
7.8 Data Safety Monitoring Plan ...................................................................................... 43
7.9 Study Modification .................................................................................................... 448
7.10 Study Discontinuation .............................................................................................. 45 

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7.11 Study Completion ..................................................................................................... 45 
7.12 Conflict of Interest Policy .......................................................................................... 45 
7.13 Funding Source........................................................................................................ 45 
7.14 Publication Plan ....................................................................................................... 45 
 
 
 

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Study Number s18-01044 
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1 - Introduction 
1.1 Introductory Statement 
This document is a protocol for a human research study. The purpose of this protocol is to 
ensure that this study is to be conducted according to ICH GCP guidelines (CRF 21 Part 
312), applicable government regulations and Institutional research policies and procedures. 
 
 

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2 - Background 
2.1 Background/prevalence of research topic 
Although the prevalence of type 2 diabetes [T2D] has remained steady in recent years, T2D 
remains a significant cause of morbidity and mortality, particularly in vulnerable populations 
who continue to suffer disproportionately higher rates of complications. For example, only 
53% of patients with T2D meet American Diabetes Association hemoglobin A1c (HbA1c) 
target of <7%. The number of patients who fail to meet this target is even higher in safety-
net primary care practices - a place where most vulnerable populations receive their care. 
To date, the care of patients with T2D has focused largely on patient self-management 
(adoption of healthy lifestyle, medication adherence) and the use of clinical parameters such 
as HbA1c levels to determine treatment effectiveness. Although several meta-analyses 
support the link between improvements in patient self-management and reduction in HbA1c, 
their effect sizes are modest at best (-0.43% reduction in HbA1c), particularly among 
vulnerable populations (only -0.31% reduction in HbA1c). 
 
 
 

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3 - Rationale/Significance 
3.1 Problem Statement 
A major limitation of the current type 2 diabetes literature is the lack of focus on patients' 
perspectives of the physical and psychosocial impact of T2D on their daily lives as well as 
their ability to manage the disease and adhere to the recommended treatment regimen. 
Importantly, psychosocial factors (e.g., distress), which are not often captured in clinical 
practice, are of utmost importance to T2D patients' health behaviors. Measures of patient-
reported outcomes (PROs) are a standardized and quantifiable approach that allows the 
collection and integration of data on patients' perspective into the clinical management of 
T2D.  Despite the central role PROs play on T2D patients' ability to manage their disease, 
PCPs overestimate how frequently they assess PROs in the clinic visit, as compared to 
patients (76% vs. 55%, respectively). However, if we are to make an impact on the growing 
burden of T2D on patients and the broader society, treatment strategies must seek to 
balance primary care providers' (PCP) pursuit of glycemic control against patients' 
emotional, physical, and social experiences with their disease. In order to be successful 
such strategies must possess the following qualities:1) provide data that is actionable by 
pport patient engagement in their care both within and 
workflow, as part of the electronic health record (EHR). Practice-based trials that evaluate 
the efficacy of integrating PROs into the care of T2D patients in safety-net primary care 
ti
i
t it
b
i
t

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practices, is at its embryonic stage.
  
3.2 Purpose of Study/Potential Impact 
Although achieving glycemic control is of clinical importance, it is the daily experiences of 
living with T2D that drive patients' decisions to adhere to treatment recommendations and 
become engaged in their care. Even with the most efficacious treatments, failure to 
incorporate patients' perspective of their disease into clinical decision-making will make 
achieving the outcomes desired by patients and PCPs unattainable. Thus, an ideal 
opportunity to improve patient outcomes is being missed in primary care practices, 
especially among vulnerable populations who suffer disproportionately higher rates of 
complications. To date, PROs have been associated with improvements in quality of life, 
better patient-provider communication, and reduced emergency department visits among 
patients with chronic diseases. Despite these benefits, practice-based studies that 
incorporate PROs into diabetes care have lacked patient and PCP involvement in their 
development thus, they fail to meet the unique needs and preferences of patients, and lack 
the technical infrastructure to support their integration into the clinic workflow, greatly limiting 
their impact. If successful, this study will lay the foundation for developing a disseminable 
strategy for improving clinical and functional outcomes in patients with T2D. Specifically,  
this study will provide much needed evidence in three vital areas: 1) the facilitators and 
the conditions under which mHealth interventions 'work' in primary care settings and the 

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organizational, individual and technical f
the theoretical drivers that underlie mHealth interventions to improve outcomes. These 
results should have important population health value for patients, providers, healthcare 
systems and policy makers by identifying the optimal set of tools and procedures to 
effectively collect and monitor PROs in patients' daily lives and as part of routine clinical 
care. 
3.3.1 Potential Benefits 
The intervention is expected to benefit the patients by improving adherence to self-care 
behaviors, reducing their cardiovascular risk profile, increasing their role as active 
participants in the management of their health, and potentially improving their diabetes 
control.  The intervention is expected to benefits PCPs by improving communication with 
their patients helping to inform treatment-decisions for effective management of T2D. The 
knowledge gained from this study will also provide key academic, community, and policy 
stakeholders a patient-centered intervention approach for chronic disease management that 
has potential for broad dissemination, ultimately contributing to a reduction in the burden of 
T2D in vulnerable populations and the broader society. 
3.3.2 Potential Risks 
Though we expect the level of risk due to this project to be minimal, potential risks may 
include the following: 
Violation of participant privacy and confidentiality: There is a potential risk to the PCPs and 

12 
patients with regards to violations of privacy and confidentiality, since text messages, 
emails, and recordings of interviews, focus groups, and real patient-PCP clinic visits will be 
used as a source of data. To mitigate this issue, all recorded sessions will be conducted in a 
private room in the FHC or FGP. Also, when sending recruitment information by email: Send 
Safe secure email will be used to contact patients. NYU Langone does not permit sending 
any patient health information via unencrypted email. 
Privacy and Security Protections for Participants: To mitigate any breaches in security or 
privacy as it relates to the Modern Journal System (MJS) DIABETES intervention, we will 
adhere to policies by the Federal Office of the National Coordinator for Health IT as well as 
the principles of the Markle Framework for Networked Personal Health Information and the 
technical specifications of the O-Auth protocol for user authentication. Based on these 
sources, the Privacy and Security Plan will include: 
 
Development of explicit policies governing the access to individual PRO data in the 
MJS intervention (e.g., limited to study staff who require it for authorized, legitimate, 
and documented purposes) 
 
A firm policy prohibiting the study staff or consultants (i.e., Rip Road, Dr. Rosal) from 
access to individual patient health records, except for specific purposes of research 
approved by the IRB 
 
Encryption of all sensitive user data within the MJS mobile platform and EHR 
interface to prevent unauthorized access and disclosure in the case of a physical 

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loss.  No personal health information (PHI) will be collected through the MJS 
platform. 
 
Regular training and reminders sent to study staff and consultants about system 
security and the need to follow related protocols to protect the confidentiality of user 
information. Policies will also be established for handling violations to security 
protocols, if they arise. 
 
A protocol outlining regular risk assessments and system audits to ensure a secure 
transmission of patients' data, including use of encryption protocols such as Secure 
Socket Layer (SSL) technology. The inclusion of Dr. Pasco as a co-I on the proposal 
will ensure that these Privacy and Security guidelines are in accord with norms and 
existing practices within the clinic. 
Protections against Violations of Confidentiality: As part of the process involved in obtaining 
written informed consent, all patients/PCPs will be reminded that their responses are 
confidential and that they may refuse to participate in the project or withdraw at any time 
without explanation, and further, that such an action will in no way affect their future 
interactions with the FHC and/or FGP. To ensure confidentiality, data will be associated with 
an individual participant only by an assigned identification number, the code for which will be 
kept in a locked drawer. Only members of the research team will have access to the 
participants' personal information file.  All computers containing confidential data will meet 
security requirements established by the HIPAA Security Rules, and established by the 
Office of Management and Budget (OMB) in OMB Circular No A 130 Appendix III

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Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - 
Security of Federal Automated Information Systems. Specifically, all electronic interview 
data will be saved on a secure server housed by NYULMC and backed up daily or weekly 
depending upon the receipt of data. PHI will be confined to a secure server that is not 
connected to the Internet. All computers will be password protected and on a private LAN 
network. No file and database servers are accessible to the public through the Internet. Prior 
to inclusion in any data set (internal and external), data will be stripped of all identifying 
information. 
Since text messages will be transmitted in this study, a variety of measures will be used to 
reduce information security risk. Patients' text responses will be securely handled via Rip 
Road's HIPAA compliant hardware infrastructure. Rip Road follows a set of well-developed 
policies and procedures vetted by top healthcare organizations in the management and 
protection of all data tracked through MJS. Patient information will be de-identified for 
administrative views and for analysis within the Rip Road system. Text messages will not 
identify patients as having a specific disease or include any PHI information such as 
patients' name. Patients will be informed that their data are stored, without identifiers, in the 
highly secure HIPAA-compliant Cloud.  They also will be informed that there is a remote 
possibility that the Cloud or their mobile account could be hacked and that information about 
study activities (communications, recorded behaviors) could be disclosed.  However, these 
data are not sensitive in nature. Devices will be configured with a participant ID and no other 
personal identifiers. It is possible that a participant could lose their mobile phone or leave it 
in a public location with the screen turned- on, enabling others to view personal information.  

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To address this, we will assist the participant in enabling a screen saver that is activated 
when the mobile phone has been idle for 5 minutes, as well as a 4-digit password that must 
be entered each time the device is turned-on. They will also be instructed on how they can 
turn off home screen notifications if they choose to. Finally, all study staff will be trained in 
the NYULMC Research Practice Fundamentals, which include training in issues of 
confidentiality and requires trainees to sign a confidentiality agreement. 
Anxiety: There is a potential risk that participants (PCPs and patients) may feel anxious 
during the audiotaped sessions. To mitigate this issue, the research assistant (RA) who 
collects the data will be trained to act professionally and address all patients' concerns. 
Participants will also be informed that they do not need to answer any questions that they 
are not comfortable with. To insure privacy during the completion of study measures, 
participants will complete questionnaires in a room with the door closed. In regards to the 
taped sessions, PCPs/patients will be reminded that the tapes are only for research 
purposes and will not influence their relationship with the FHC and/or FGP. Moreover, they 
will be reassured that the tapes will be saved in a secure and confidential database that only 
the study staff will have access to, and that have the right to ask that the tapes be deleted if 
they feel sensitive information was discussed during the sessions that they do not want the 
research team to hear. 
Hyper- or hypoglycemia: Since this study is recruiting patients with uncontrolled T2D, 
occasionally someone may have low blood sugar or high blood sugar during their study 
participation. All patients will 

14 
conceivable that a patient reports blood glucose data that will require more aggressive 
management. When problems arise suggesting the need to re-evaluate the medication 
regimen, participants will be referred to their provider of record, or local emergency room as 
appropriate. 
 
 
 

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4 - Study Objectives 
4.1 Hypothesis 
Among 282 patients with uncontrolled type 2 diabetes (HbA1c levels > 7%), those 
randomized to MJS DIABETES, compared to UC, will: 
Hypothesis 1 (Primary Aim): Exhibit a higher mean reduction in HbA1c at 12-months. 
Hypothesis 2a (Secondary Aim 1): Report higher rates of adherence to self-care behaviors 
at 12 months.  
Hypothesis 2b (Secondary Aim 2): Report greater improvement in diabetes knowledge, self-
-provider communication, 
which in turn will be associated with higher rates of adherence and higher mean reduction in 
HbA1c at 12 months. 
 
4.2 Primary Objective 
To compare the efficacy of MJS DIABETES vs. usual care (UC) on HbA1c reduction at 12-
months. 
4.3 Secondary Objectives (if applicable) 
3. To compare the efficacy of MJS DIABETES vs. UC on adherence to self-care 
behaviors

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behaviors.
4. To evaluate the potential mediators of the intervention effects (diabetes knowledge, 
self-efficacy, outcome expectation, and patient-provider communication) on 
adherence to self-care behaviors and HbA1c reduction. 
 
 

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5 - Study Design 
5.1 General Design 
Using a mixed-methods design, the study will be conducted in two phases: 1) A formative 
phase, based on user-centered design and 2) a clinical-efficacy phase (see Figure).  
 
The goals of the formative phase are three-fold: First, we will use focus groups to adapt MJS 
STATWISE to the needs of the PCP and T2D patients, including Spanish-speaking patients. 
Second, we will conduct a design workshop to integrate MJS DIABETES into the EHR 
system and patient's lives. Third, we will evaluate the usability of MJS DIABETES in a 
subset of T2D patients and their PCPs in order to optimize the tool's performance and 
workflow integration prior to the clinical efficacy trial. For the clinical efficacy phase, we will 
conduct a RCT trial to evaluate, among a sample of 282 patients with uncontrolled T2D, the 
efficacy of the adapted MJS DIABETES versus UC on reduction in the levels of HbA1c 
(primary outcome) and adherence to self-care behaviors (secondary outcome). In addition, 

16 
we will examine the role of diabetes knowledge, self-efficacy, outcome expectations, and 
patient-provider communication as potential mechanisms of the effect of the MJS 
DIABETES on HbA1c and adherence to self-care behaviors (secondary outcome). Patients 
randomized to MJS DIABETES will receive and respond to daily PROs via text messages 
and report SMBG (if insulin-dependent) over the course of the 12-month study. They will 
also receive feedback and motivational messages based on patterns of their PROs. Finally, 
patients and PCPs will receive journal reports that visually display the PROs to encourage 
decision-making and patient engagement during their clinic visits. PCPs will be able to view 
the PRO reports via the MJS-EHR interface during clinic visits with the patient or to track 
patients' PROs between clinic visits. Patients randomized to the UC arm will receive 
standard diabetes treatment as determined by their PCP.  
Phase 2 of the study will not begin until all materials for this phase have been fully 
developed. These materials will then be submitted to the IRB via a modification for review 
and approval. 
The primary outcome is mean change in HbA1c from baseline to 12 months. Secondary 
outcomes include 1) changes in patient adherence to self-care behaviors, (e.g., lifestyle 
 and 2) theoretical mediators of diabetes knowledge 
(capability), patient-provider communication (opportunity) and diabetes self-efficacy and 
outcomes expectations (motivation).  
5.1.1 Study Duration (if applicable) 

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The study duration is 24 months.  The formative phase will be the first 12 months of the trial 
to refine the study intervention.  The clinical efficacy phase will be 12 months and there will 
be six patient visits: screening/consent, baseline, 3-month, 6-month, 9-month, and 12-month 
follow-up. 
5.1.2 Number of Study Sites 
The study will be conducted at the network of 10 safety-net Family Health Centers (FHC) 
and Faculty Group Practices (FGPs) at NYU Langone Health. 
5.2.1 Primary Outcome Variables 
The primary outcome, mean reduction in levels of HbA1c, will be extracted from patients' 
medical records.  We will use the average of 3 glucose readings over the prior 3 months 
surrounding the study visit date to calculate mean levels of HbA1c. 
5.2.2 Secondary and Exploratory Outcome Variables (if applicable) 
The secondary outcomes are:  
1) Patient adherence to diabetes self-care behaviors (e.g., dietary behaviors, medication 
adherence, foot care), which will be assessed with the self-report measure Summary of 
Diabetes Self-Care Activities questionnaire 
2) The theoretical mediators: (a) Patient capability assessed with the self-report diabetes 
knowledge scale, (b) patient motivation assessed with the self-report diabetes self-efficacy 
and outcomes expectations scales, and (c) patient perceptions of opportunity (patient-

17 
provider communication) assessed with the self-report Interpersonal Processes of Care 
survey. 
5.3 Study Population 
The study will be conducted at the network of 10 safety-net Family Health Centers (FHC) 
and Faulty Group Practices (FGPs) at NYU Langone Health. English and Spanish are the 
most common languages spoken with approximately 62% of patients self-identified as 
Latino, 21% as Black, and 13% as White. Majority of patients have Medicaid. In 2015, the 
FHCs provided care to 5,218 patients with T2D. Of these patients, 58% had an HbA1c>7% 
(n=3,026). The FGP consists of at least 657 additional eligible private practitioners in 351 
private practices.  Approximately, 55% of patients have poor diabetes control. 
Selection rationale: The prevalence of T2D has grown to epidemic proportions and is largely 
considered one of the most significant public health problems in the US, in terms of 
morbidity, mortality, and economic burden. While a great deal of effort has been spent 
assisting PCPs in delivering guideline-concordant care to achieve glycemic control, less has 
been spent facilitating patient's perspective of their disease into care. As a result, an ideal 
opportunity to improve patient outcomes is being missed in primary care settings, especially 
among vulnerable populations who suffer disproportionately from its complications.  Thus, 
this study will include diverse English and Spanish-speaking patients who receive care in 
safety-net practices. 
5.3.1 Number of Participants 

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Fourteen PCPs and 36 patients with uncontrolled type 2 diabetes (T2D) from the network of 
Family Health Centers (FHCs) and Faculty Group Practices (FGPs) at NYU Langone Health 
will be recruited for participation in the formative phase of the study. 
Fourteen PCPs and 282 patients with uncontrolled T2D from the network of FHCs and 
FGPs at NYU Langone Health will be recruited for participation in the clinical efficacy phase 
of the study.  To mitigate bias, PCPs and patients that participated in the formative phase 
will be excluded from participating in the clinical efficacy phase. 
To meet our patient recruitment goals, we will begin by screening 3,026 patients. We 
estimate that 40% of screened patients (n=1,210) will satisfy the inclusion criteria, and that 
50% of the will have an A1c>7% at baseline visit (n=605). We estimate that approximately 
55% of those 363 patients will agree to participate, leaving 282 for our study after 
accounting for attrition.  
5.3.2 Eligibility Criteria/Vulnerable Populations 
PCP Eligibility Criteria 
Inclusion Criteria: (a) Fulltime primary care provider (MD/DO, NP) practicing at the 
participating FHCs or FGPs and, (b) Provide care to at least five patients with a diagnosis of 
T2D. 
Exclusion Criteria: Refuse to participate 
Patient Eligibility Criteria 

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Inclusion Criteria: 
 
 
 
Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least 
 
 
 
 
 
 
Be > 18 years of age. 
Exclusion Criteria: 
 
Refuse or are unable to provide 
 
 
Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, 
renal transplantation, or other ESRD-
 
 
Have significant psychiatric comorbidity or reports of substance abuse (as 
doc
 
 
 
 
 
 
Plan to discontinue care at the clinic within the next 12 months. 

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We are targeting social and economically disadvantaged patients due to the high prevalence 
of T2D and related complications in this population. 
We are also targeting employees of the FHCs and FGPs. Primary care physicians (PCP) 
who agree to take part in this study will not be recruited or consented by any individuals in a 
supervisory position. Moreover, PCPs will be informed that their decision to participate or to 
not participate in the study will have no effect on their employment at the FHCs or FGPs. 
 
6 - Methods 
6.1.1 Description of Intervention 
Formative Phase (Phase 1): Based on the methodology employed in our previous mHealth 
studies, we will use the evidence-based user-centered design (UCD) approach to 
systematically gather and incorporate feedback from patients and PCPs for selection and 
adaption of the appropriate PROs for use in MJS DIABETES. We will use the UCD 
approach to also optimize and integrate the MJS report into the workflow of the EHR. The 
formative phase will occur in three sequential steps (Table 2): 1) Focus groups to adapt MJS 
to diverse patient and PCP needs, including those of Spanish-
workshop to understand the workflow processes for patients and PCPs and integrate MJS 
Evaluate the usability of 
MJS DIABETES in a subset of T2D patients and their PCPs to optimize the tool's 

19 
performance and workflow integration. The outcome of this phase will be a refined, 
integrated, and well-tested technology-based PRO system for T2D whose efficacy will be 
evaluated in the clinical trial efficacy phase. 
 
Focus groups: We will conduct audiotaped focus groups with patients and PCPs.  Four 
focus groups will be conducted with patients (two with English-
Spanish-
-8 patients per group) and two focus groups will be conducted 
with PCPs (4-7 PCPs per group). Each focus group will be conducted via WebEx, be 
audiotaped, and last for approximately 2 hours in duration. Patient focus groups will be 
conducted to identify the barriers and facilitators to uptake of the MJS intervention and 
inform the initial program content. Patients will be asked to identify the most important 
symptoms, complications, side effects, and health-related quality of life concerns associated 
with their T2D and treatment experiences of T2D using validated patient reported outcome 

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measures (e.g., Diabetes Health Profile (DHP)-18) as a guide. In addition, the goal of the 
focus groups with Latino patients is to culturally adapt the PROs collected in the MJS 
intervention to needs, experiences and preferences of Spanish-speaking Latino patient 
users. The PCP focus group will be conducted to elicit feedback on the PROs identified in 
the patient focus groups, visual representations and placement of the PROs in the EHR, and 
barriers and facilitators to use in the PCP workflow. All audiotapes from the focus groups 
and interviews will be transcribed verbatim (and translated into English for the Spanish-
speaking groups). 
Design Workshop Upon completion of the focus groups, the study team will convene a one-
day design workshop in collaboration with Rip Road to further develop the MJS PRO 
content and ideal workflow integration. The workshop will consist of 4 PCP and 4 patient 
representatives from the focus groups described above. The workshop will be led by co-I Dr. 
Mann and guided by a UCD protocol that sequentially leads the group through a variety of 
activities designed to elicit feedback on key components of the MJS adaptation (e.g. paper 
mock ups of tool design) as well as the proposed clinic workflow/patient journey (e.g., 
patient "day in the life" map) integration of MJS.  Following the design workshop, Rip Road 
will partner with the study team to embed the MJS-EHR visualizations into Epic. 
Usability Sessions: Once the prototypes are created, we will evaluate the workflow 
processes of the bilingual MJS diabetes intervention via usability testing with a purposive 
sample of patients and PCPs drawn from the focus group participants. Four patients and 
four PCPs will complete individual usability sessions with a beta version of the intervention 

20 
to provide preliminary performance data on its functioning. Table 4 describes the metrics 
that will be collected during the testing 
sessions. Patients and PCPs will also 
suggest refinements to the mock content 
and workflow/user journey map from the 
PCP and patient perspectives —— 
providing key feedback on topics such 
as potential disruption to the clinic 
workflow, impact of using interpreter 
services on discussions of the PRO 
report, and placement/presentation of 
the report in the EHR. Our previous 
studies suggest that we will need four 
patient and four PCP cycles of usability 
sessions to reach saturation. Each 
usability session will be approximately 
one hour in duration. The primary output 
of this step is the fully functional, integrated MJS DIABETES intervention for testing in the 
clinical efficacy trial. 
Description of MJS DIABETES intervention (Phase 2) 

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Phase 2 of the study will not begin until all materials for this phase have been fully 
developed. These materials will then be submitted to the IRB via a modification for review 
and approval. 
Patient intervention: MJS DIABETES is comprised of 5 components: 1) PRO assessments, 
-driven feedback 
text messages 4) motivational te
PRO data. 
MJS helps patients (and their provider) see how their diabetes symptoms and psychosocial 
functioning are changing overtime. Participants who enroll in the study agree to have 
messages sent to their phone based on one of several PRO categories. These include: (1) 
diabetes 
motional health
ifestyle behaviors
edication 
adherence
hysical functioning. PRO questions will be sent on a daily or weekly 
basis, depending on the PRO (i.e., adherence is a daily measure while quality of life is sent 
on a weekly basis).  The list of potential PROs that will be sent to patients over the course of 
the 12-month study and their primary questionnaire source are shown in the Table below. 
No PHI will be collected in the MJS DIABETES tool.  All data is a numerical response that is 
anonymous. 
Potential MJS PROs 
Scaling
Source 
Over the past week, how would you rate your level of fatigue 
because of your diabetes? 
0 (not at all tired)-10 
(extremely tired) scale 
Global Health PROMIS 
Tool 
 
How would you rate your sleep quality over the past 7 days?
0 (very poor)-10 
NIH PROMIS Sleep 

21 
(excellent) scale
Quality
Over the past week, how often were you able to take your 
diabetes medication on time? 
Never 
Rarely 
Sometimes 
Often 
Always 
Diabetes self-management 
questionnaire
How many of the last seven days have you followed a 
healthful eating plan for diabetics? 
0-7 days 
Summary of Diabetes Self-
Care Activities 
In general, my present quality of life is  
As good as it can be 
Good 
Quite good 
Neither good or bad 
Quite bad 
Bad  
As bad as it could 
possibly be 
Audit of Diabetes 
Dependent Quality of Life
 
Over the past week, how often were you been bothered by 
emotional problems such as feeling anxious, depressed or 
irritable because of your diabetes? 
Never 
Rarely 
Sometimes 
Often 
Always 
Global Health PROMIS 
Tool 
 
Over the past week, what percent of the time did you take all 
your diabetes medications as your doctor prescribed?
0-100%
Self-Rating Scale Item
On how many of the last seven days did you take the 
correct number of (pills/injections) for this medication?  
0-7 days 
Summary of Diabetes Self-
Care Activities  
Over the past week, how often did you eat [favorite 
unhealthy food]?   
 
Always 
Often 
Sometimes  
Rarely 
Never 
Perceived Dietary 
Adherence Questionnaire 

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On how many of the past 7 days did you eat lots of sweets 
or other foods rich in carbohydrates? 
0-7 days 
Perceived Dietary 
Adherence Questionnaire 
How effective are you in coping with your diabetes?
1 (not at all) to 5 
(extremely effective) 
Appraisal of Diabetes 
Scale 
How many times over the past week did you eat desserts 
like cookies, cakes and muffins or other sweets?  Do not 
include sugar free kinds. 
Never 
1 time
2-3 times 
4 or more times
NHANES Dietary Screener 
Questionnaire 
How many times over the past week did you refined 
carbohydrates like white bread, white flour tortillas, dinner 
rolls and bagels? 
Never 
1 time
2-3 times 
4 or more times 
NHANES Dietary Screener 
Questionnaire 
On how many of the past 7 days did you space 
carbohydrates evenly throughout the day?
0-7 days 
Perceived Dietary 
Adherence Questionnaire 
Over the past week how well could you control your 
emotions? 
Not at all
Poorly 
Fairly well 
Very well 
Extremely well 
Thrive Questionnaire
In general, how would you rate your mental health, 
including your mood and your ability to think? 
Poor 
Fair
Good 
Very good
Excellent
Global Health PROMIS 
Tool 
 
How much was the quality of life of your life affected by the 
time required to control your diabetes?  
 
0 (Not at all affected) –
10 (as bad as I can be) 
Patient-reported outcome-
Quality of Life  
Over the last week, did you experience any weight gain 
because of your diabetes
Always 
Often
Diabetes Impact 
Measurement Scales

22 
y
Sometimes  
Rarely 
Never 
Over the last week, did you feel irritable or moody because 
of your diabetes 
Always 
Often 
Sometimes  
Rarely 
Never 
Diabetes Impact 
Measurement Scales 
In addition to the PRO questions, patients will receive feedback via motivational and data-
driven text messages. These text messages are designed to activate patients in their care 
via continued participation in the MJS program, and to provide them feedback data on 
patterns in their responses for self-reflection. 
We  have developed and tested three types of data-driven feedback messages that were 
automatically sent to patients on a weekly basis describing patterns in their PRO 
assessments over the past week.  The high/low comparison messages compared the lowest 
(shortest) value reported (to date) to previous weeks, in which higher (longer) value were 
reported. The weekly average comparison messages compared changes in patients’ mean 
PRO ratings for the current week as compared to the previous week. The re-occurring 
values messages also compared multiple weeks over time, data from single days during the 
week to days in previous weeks, and multiple [single] days over time. We use a rule-based 
algorithm that searches for these patterns in patient’s data on a weekly basis.  Specifically, 
the high/low comparison and re-occurring value messages will be sent if the appropriate 
patterns in the data are identified for the current week. If no patterns in the data are 

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identified, the weekly average comparison message will be sent as the default message 
each week.  Example messages from our pilot include the following: 
Comparison High/Low Message:  Last [day of the week] your average FATIGUE score 
was a "[numerical fatigue score]."  That is the lowest score you have reported in the past [#] 
of weeks. 
Comparison Multiple day Message:  In the past week your FATIGUE scores have been: 
"[day of week – 
– numerical fatigue 
score f
– numerical fatigue score for that day]”. 
Average PRO value Message: Your average FATIGUE score this week was a "[numerical 
fatigue score]", compared to your average fatigue score of "[numerical fatigue score]", last 
week. 
Motivational messages are also automatically generated and delivered via a pre-specified 
algorithm.  There are two categories of motivational messages:  (1) Response-based (i.e., 
sent in response to high/low compliance in replying to assessment entries) and (2) % 
completed (i.e., sent after specified time intervals of participation).  Example messages 
include:  
Low Compliance Message (always triggered if 3 consecutive days are missed): We 
haven't heard from you in the last 3 days. Text HELP if you need assistance in the 
journaling program. 
Good Compliance Message Yo
ha e ans ered 12 te t messages in a ro
for the

23 
Good Compliance Message: You have answered 12 text messages in a row for the 
journaling program.  Keep it up! 
% Completed Message 1: You have responded to 85% of the messages over the past 4 
weeks in the journaling program. 
% Completed Message 2: Congratulations! You are halfway through the journaling 
program. 
Mobile Opt-in/Opt out Process: After completing informed consent, patients randomized the 
intervention condition will meet with the RA to receive training on how to use the intervention 
and opt in to receive SMS messages.  Per carrier policies to opt in, patients must provide 
their mobile numbers and carrier information.  Once their information has been added to the 
system, they will receive a SMS asking them to reply to confirm their participation.  To 
confirm, patients will need to reply via text message. 
This step verifies their mobile number and joins them to the intervention.  They will receive a 
welcome message. 
To cancel or opt out of the program at any time, patients will be required to send the word 
‘STOP’ to any program message.  This information is communicated to the patient at the 
time of registration, via a Mobile Terms and Conditions document – which they will be 
required to sign.  The opt out information is also communicated to them within the first 
program confirmation SMS, as well as once a month, in a SMS message sent as part of 
their subscription service. 

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All additional carrier compliance terms will also be adhered to.  A HELP message, and an 
invalid response message will be developed.  Carrier specific rate information will be 
included in messages as required.  
Patients will then be instructed on how to respond to the SMS messages and asked to 
demonstrate their ability to understand. 
Journal report: After the first week, and every 2 weeks thereafter, patients will receive a 
journal report that visualizes their responses to the text message questions in 
straightforward graphs and displays the adherence responses in a calendar. The reports are 
intended to help patients reflect on changes in their responses overtime, and discuss how 
their symptoms and functioning have changed in between visit.  
 
PCPs: The EHR-integrated journal reports will provide PCPs with quantitative assessments 
of the extent to which patients are adhering to their T2D regimen, the psychosocial factors 
that may inhibit adequate glycemic control, and the diseases impact on their functional 
status. Reports of patient PRO data will be uploaded to the EHR every two weeks. Providers 
will be able to access reports of patients' PRO data via the MJS-EHR interface during visits 
with the patient or asynchronously to track patients' PROs between visits. Based on our pilot 
data, we will encourage providers to use the reports to support patient engagement and 
shared decision-making in the clinic visit, set priorities for the visit, and discuss trends in 
PRO data as they relate to behavioral and clinical outcomes. Prior to the initiation of the trial, 

24 
all participating PCPs will receive standardized training in the MJS-EHR interface 
functionalities as well as best practices for patient-centered discussions of the data 
visualizations (Table 6). The ability to receive and review PRO reports between clinic visits 
may also offer several opportunities to improve patient care such as by: reducing critical 

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illness (symptoms, function and well-
requirements for two-way electronic communications. 
Description of UC group 
Patients randomized to the UC group will receive standard diabetes treatment 
recommendations as determined by their PCP. Rationale for UC condition: The UC group 
was designed to mimic usual care as delivered in primary care practices. We believe that 
including an alternate approach such as an attention control condition would defeat the 
purpose of this trial, which is to compare the efficacy of an innovative approach to collect 
and track PROs for diabetes self-care in real-world practice-based settings with particular 
attention to its integration into standard clinical practice. 

25 
 
6.1.2 Method of Assignment/Randomization 
This project has a hierarchical study design with each patient nested within a PCP thus, 
randomization will occur within PCP.  The study statistician (Dr.Li) will oversee 
randomization, which will be carried out using a SAS macro after completion of the consent 
procedures and baseline data collection. Patients will be randomly allocated to either the 
intervention (MJS DIABETES) or UC at a 1:1 ratio. A random number from 0 to 1 will be 
used to determine to which group the subject is assigned. The standard cut score will be set 
at 0.5 for the first n subjects from the same PCP. Those who receive a random number 
between 0 and 0.5 will be assigned to the UC group and those with a random number 
greater than 0.5 will be assigned to the MJS group. The balance between the groups within 
each PCP will be carefully weighted after the total number of subjects from a PCP reaches a 
number greater than n. Before the randomization procedure, the number of subjects 
randomized to each arm of the study for each PCP will be estimated using SAS macro 
programs. If more than the n subjects are randomized initially, the cut score for the next 
subject is equal to the ratio of the experimental arm (n1) to the subjects already randomized 

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(m) for that PCP (n1/m). The randomization log will be stored in a secure file, and will be 
password protected. Once a patient has met eligibility criteria and provided consent, the 
program manager will call the study statistician for the patient's group assignment. As is true 
for most behavioral interventions, the patient cannot be blinded to the group assignment. 
However, it is plausible that study staff could bias the study outcome by knowing the 
patient's group assignment. To mitigate the potential for this bias, the RA that is responsible 
for data collection will be blinded to the patients' group assignments and study hypotheses 
(i.e., single blind design).  
6.1.3 Selection of Instruments/Outcome Measures 
Table 7 describes the measures that will be administered and their timing.  Below, we 
describe each measure in detail. 
HbA1c level: will be assessed as the difference between HbA1c at baseline and 12 months. 
HbA1c levels will be extracted from patient's clinic EHR. HbA1c levels will be calculated as 
the average of all available clinic measurements for the 90 days surrounding the targeted 
study visit dates. If a participant does not have an HbA1c value within the EHR for any 
particular follow-up visit, a lab test will be scheduled to obtain a measure. Clinic HbA1c 
measurements made during 6 months prior to randomization will be treated as the baseline 
period. 
Medication adherence: will be assessed at baseline and 12 months. The Voils Self-Reported 
Medication Nonadherence Measurement will be used to assess the extent of nonadherence 
d
f
dh
T
ti
t
ti
t ’
dh
t
di
ti
i
th

26 
and reasons for nonadherence.To estimate patients’ adherence to a medication regime, the 
Proportion of Days Covered (PDC) metrics will be used. PDC metric is defined as a ratio of 
following: Numerator- days patient took drug/ Denominator- number of days between the 
first fill of the medication during the measurement period and the end of the measurement 
period. 
Charlson Comorbidity Index- is a method of categorizing comorbidities of patients based on 
the International Classification of Diseases (ICD) diagnosis codes found in administrative 
data, such as hospital abstracts data. Each comorbidity category has an associated weight 
(from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the 
weights results in a single comorbidity score for a patient. A score of zero indicates that no 
comorbidities were found. The higher the score, the more likely the predicted outcome will 
result in mortality or higher resource use 
Patient adherence to self-care behaviors will be assessed with the well-validated Summary 
of Diabetes Self-care Activities Measure. For this measure, patients are asked to indicate 
how many of the past seven days (response range 0 -7 days) they practiced the following 
self-care behaviors: follow a general diet, follow a diabetes specific diet, be physically active, 
monitor blood glucose, engage in foot care, and smoke (scored as a yes or no response).  
In the analyses, we will examine each behavior separately due to studies showing that 
engaging in one of the self-care behaviors does not correlate with practicing another 
behavior.  The Cronbach's alpha for the scales range from 0.69 to 0.84). 

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Patient knowledge (capability): will be assessed with the Diabetes Knowledge Scale, which 
contains 2 sections that are each scored separately. The general knowledge segment of the 
test has 14 items and is appropriate for adults with type 1 and type 2 diabetes. An additional 
9 items constitute the insulin use subscale that is appropriate for adults with type 2 using 
insulin. The test's readability was measured by the Flesch-
level was calculated at the fourth-grade reading level. The coefficient alphas indicate that 
the scale is reliable for both the general test (.77) and the insulin use subscale (.84). 
Patient self-efficacy (motivation): will be assessed with the 12-item Diabetes Self-efficacy 
Scale, which is assessed using a 10-point response from "1 = not at all confident" to "4 = 
very confident." For each item patients rated their confidence in their ability to perform a 
recommended self-care routine. Responses are summed to obtain an overall self-efficacy 
score, and for ease of interpretation, are transformed the score to a 100-point scale with a 
higher score representing greater self-
0.78, across diverse race/ethnicity populations and health literacy levels.  
Patient diabetes distress: will be assessed with the well-validated and widely used 17-item 
Diabetes Distress Scale, which is assessed using a Likert type scale from “1= not a 
problem” to “6= a very serious problem.” For each item patients rated the degree of distress 
the potential problem a person with diabetes may experience. To score, the sum of all the 
patient’s responses is divided by 17. A mean score of 3 or higher is considered a level of 
distress that needs medical attention.  In the event of an elevated score, a message will be 
sent to the patient’s primary care provider and be noted in the patient’s study record. 

27 
Patient outcome expectations (motivation):  will be assessed with the 20-item Outcome 
Expectations Questionnaire (adapted from McCaul et al., 1987), which assesses 
participants' perceptions of the positive and negative consequences of performing diabetes 
self-care behaviors (e.g., "If I exercise daily, my diabetes will be better controlled").  The 
measure has been previously validated in a diverse sample of patients with type 2 diabetes, 
 
Patient-provider communication (opportunity): will be assessed with the Interpersonal 
Processes of Care Survey, a patient-reported, multidimensional instrument designed to 
assess interpersonal aspects of care.  It is validated for patients of diverse racial/ethnic 
groups and available in Spanish and English.  The IPC assesses 7 subdomains of 
communication, patient-centered decision making, and interpersonal style.  As in previous 
studies, we will also include diabetes-specific communication items related to the 
fundamental areas of diabetes education including: diet ("how to plan your meals to improve 
 
Patient demographic data will include race/ethnicity, place of birth, years in the US, primary 
language, age, gender, household income, education level, marital status, employment 
status, health insurance status, smoking and drinking behaviors, and medical comorbidity. 
PCP demographic data will include gender, race/ethnicity age, years of medical practice, 

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years practicing at the FHC or FGP, and how well they know the patient (range from very 
well to not at all).  
Characteristics of disease and medication regimen: All patients will have their EHR reviewed 
at baseline and 12 months. Information extracted from the charts will include diabetes 
characteristics such as clinic HbA1c readings, duration of diabetes, evidence of target organ 
damage, changes in diagnosis, medical comorbidity, clinic appointment attendance, and 
other medications prescribed and their dosages. In addition, we will collect information on 
the number and classes of diabetes medications prescribed and dosages as this reflects the 
intensity of treatment by providers and will serve as a covariate in the analysis to allow us to 
account for the influence of medication management on changes in HbA1c over the course 
of the study. 
Health Care Utilization: Will be assessed at 6 month and 12 month follow-ups. Health care 
utilization is a self-reported questionnaire that assesses the use of healthcare services such 
as hospitalization, clinic visits and emergency department visits for T2D care for every 6 
months during the course of the trial. 
Perceived usefulness: will be measured with a 4-item survey that are derived from the well-
validated Technology Acceptance Model-version 3 (TAM3) survey that assesses the 
perceived benefits and drawbacks of the tool on performing tasks/job functions. This 
measure will be administered to patients and PCPs during the usability sessions during the 
formative phase as well as at the 12-month study visit.  The internal consistencies of this 
scale is 0 94

28 
scale is 0.94
Perceived ease of use: will be measured with a 4-item survey derived from the TAM3 survey 
that assesses the degree of effort that users perceive is needed to use the tool. This 
measure will be administered to patients and PCPs during the usability sessions during the 
formative phase as well as at the 12-month study visit. The internal consistencies of this 
scale is 0.93. 
Relevance: will be measured with a 2-item survey derived from the TAM3 survey that 
assesses the relevance of the tool on performing tasks/ job functions. This measure will be 
administered to patients and PCPs during the usability sessions during the formative phase 
as well as at the 12-month study visit. 
Report Quality: will be measured with a 3-item survey derived from the TAM3 survey that 
assesses the users’ evaluation of the quality of the report provided by the tool. This measure 
will be administered to patients and PCPs during the usability sessions during the formative 
phase as well as at the 12-month study visit. 
Result Demonstrability: will be measured with a 2-item survey derived from the TAM3 
survey that assesses the users’ perceived ability to explain or talk about the tool with others. 
This measure will be administered to patients and PCPs during the usability sessions during 
the formative phase as well as at the 12-month study visit. 
Communication: will be measured with a 2-item survey derived from the TAM3 survey that 
assesses whether the users communication with healthcare provider improved after using 

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tool. This measure will be administered to patients and PCPs during the usability sessions 
during the formative phase as well as at the 12-month study visit.
Behavior intention of use: will be measured with a 4-item survey derived from the TAM3 
survey that assesses the likelihood of using the tool within a specific time frame. This 
measure will be administered to patients and PCPs during the usability sessions during the 
formative phase as well as at the 12-month study visit.
Use behavior:  Data on patient and PCP use of the MJS intervention will be extracted from 
the tool at the end of the clinical efficacy phase and include the following metrics: # of 
EHR report, # clicks within EHR report, time spent in EHR report, audiotaped clinic visit.
Physician communication: will be measured with two Physician Communication surveys. 
One is a 13-item survey which is assessed using a Likert type scale from “1= poor” to “5= 
excellent” and the other a 9-item survey which is assessed using a Likert type scale from 
“1= strongly agree” to “5= strongly disagree”. Both surveys will be used to see if the 
intervention had an impact on physician’s communication skills (which we hypothesize 
would impact patient self-management behaviors) and to determine whether there was any 
contamination across study arms. 

29

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6.1.4 Intervention Administration 
Treatment Fidelity: will be based on the NIH Behavior Change Consortium Treatment 
 
intervention skills (Details of the treatment fidelity approach is outlined in Table 6 above). 
6.1.5 Reaction Management 
In the event that any of the participants (patients and PCPs) experience anxiety as a result 
of participating in the formative and/or clinical efficacy phases of this trial, we will provide a 
list of mental health services that are offered at no or low-cost through the NYU Langone 
Health network of participating FHCs and/or FGPs. If immediate attention is warranted, the 
clinic social worker and/or psychologist will be contacted. 
6.2.1 Efficacy 
The efficacy of the intervention will be assessed via the primary outcome, reduction in levels 
of HbA1c from baseline to 12 months.  HbA1c levels will be abstracted from patients' 
medical record.  
6.2.2 Safety/Pregnancy-related policy 
Patients who are pregnant or planning to become pregnant in the next 12 months are 
excluded from participation in this trial. 
6.2.2.1 Adverse Events Definition and Reporting 
(
)
f

30 
The Principal Investigator (PI) will be responsible for quality control including reviewing and 
reporting adverse events. The plan will comprise the following elements: 
 
Adverse events will be reported to the IRB.  
 
A detailed plan to address serious events that may arise during study visits, such as 
HbAic values that indicate a diabetic emergency, is in place. Critical blood sugar 
values are defined as: 300 mg/dl or higher OR less than 40 mg/dL). In the event that 
the RA encounters such readings at any point in the study visit process or via 
transmission of home readings, the following protocol will be triggered: (1) Let the 
participant know that these values are very high and recommend follow-up with 
Event Form. The Project PI and key personnel will meet every 6 months to review 
adverse events reports, participant complaints, if any, and dropout rates.  Data will 
be provided at those meetings by the investigators on key variables that may 
indicate harm, including changes in HbA1c and cardiovascular risk profile.   
 
Any unexpected adverse reactions that are associated with the research and that are 
fatal or life threatening will be reported to the IRB within 24 hours of discovery. Any 
unexpected adverse events associated with the study that are moderate to severe in 
nature, but not life threatening, will be reported to the IRB in 5 days. 

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Summaries of adverse events reports will be made to AHRQ/Merck in the yearly 
progress or report or, at the end of year 2, in the final report, unless the nature of a 
particular event is such that it bears immediate reporting to AHRQ/Merck. 
 
If a serious adverse event occurs as a result of the study, consideration will be given 
to stopping the study early. In the event of early stopping of the study, the IRB will be 
promptly notified. 
6.2.3 Pharmacokinetics (if applicable) 
Not applicable 
6.2.4 Biomarkers (if applicable) 
Not applicable 
6.3.1 Study Schedule 
In the formative phase, the total expected duration of participation for both patients and 
providers is 14 hours over the course of 12 months.  The estimated time for each visit during 
this phase is as follows: 
 
Participation in 1 focus group: 2 hours 
 
Participation in the design workshop: 8 hours 
 
Participation in usability sessions: 4 hours 
In the clinical efficacy phase, patients will participate in six study visits over the course of 12 

31 
y p
p
p
p
y
months. The duration of the intervention is 12 months, inclusive of this time.  The 
intervention includes receiving and responding to up to 3 daily text messages.  It is 
estimated to take 2 minutes to respond to all text messages each day. 
 The estimated time for each study visit is outlined below: 
 
Screening: 10 minutes 
 
Consent/Baseline: 45 minutes 
 
Follow-up visits at 3, 6, 9: 30 minutes each visit 
 
Final study visit at 12 months: 60 minutes (patients) and 30 minutes (PCPs) 
6.3.2 Informed Consent 
Both patients and PCPs will provide informed consent to participate in either phase of this 
study. The protocol and consent will be approved by the New York University IRB.  
Due to COVID-19 and to keep the safety of both our research team and research subjects, 
we will be collecting consent via telephone. A trained Research Assistant will schedule a 
time with eligible interested participants to go over the written consent via telephone. 
Research Assistants will email or mail a copy of the consent to participants in preparation for 
the telephone consent. After going over the written consent via telephone, research 
assistants will also send the consent via a RedCap link where the participant has the 
opportunity to read the consent and sign electronically, confirming that they read and 

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understood the consent. Research Assistants will also document on RedCap the time and 
date of the telephone consent and note that the consent process was done via telephone 
due to COVID-19. 
 
PCPs: A trained RA will meet with PCPs that express interest to provide a fuller description 
of the study. During this meeting, the PCP will be given a fuller description of the study in 
clear, easy to-understand language, emphasizing the points made during the 
letter/telephone/email invitation.  All PCPs will told that their responses are anonymous and 
confidential, that they may refuse to participate in the project or withdraw at any time without 
explanation and further, that such action will in no way affect their relationship with the 
primary care practice. If the PCP remains interested in participating, the RA will provide a 
copy of the consent form for him/her to read. PCPs will be asked to repeat back the salient 
points of the consent form to make sure that they understand the study they are agreeing to 
participate in. If the healthcare provider desires to participate, s/he will sign, and the RA will 
co-sign. PCPs will receive a copy of the signed informed consent. A second copy will be 
stored in a secure, locked filing cabinet in a dedicated room.  
Patients:  For phase 1 of the study, patient initial verbal consent will be conducted during a 
telephone call with a RA. During the telephone call the RA will give a fuller description of the 
study to the participant in clear, easy to-understand language, emphasizing the points made 
during the initial telephone call/letter/Epic invitation.  All patients will be told that their 
responses are anonymous and confidential that they may refuse to participate in the project

32 
responses are anonymous and confidential, that they may refuse to participate in the project 
or withdraw at any time without explanation, and further, that such action will in no way 
affect their future interactions with their PCP. If the patient remains interested in 
participating, they will have the option to either complete the focus group in-person in a 
dedicated room or via a remote session using NYU’s secure Webex conferencing platform.  
For patients opting to complete the focus group remotely, the RA will send a copy of the 
informed consent to them for signature and include a pre-stamped envelope with return 
address. The RA will also include a letter with their contact information so the patient can 
contact the RA to ask for help in reading the consent form. Patients will be asked to mail 
back their signed consent to the study team before their scheduled focus group. Once the 
informed consent is received by the RA, the RA will sign and mail a copy to the patient. The 
original consent will be stored in a secure, locked filing cabinet in a dedicated room.  
For Phase 2 of the study, patient consent will be conducted during an in-person meeting 
with a RA in a private space at the FHC or FGP.  During the meeting the RA will give a fuller 
description of the study to the participant in clear, easy to-understand language, 
emphasizing the points made during the initial telephone call/letter/Epic invitation.  All 
patients will told that their responses are anonymous and confidential, that they may refuse 
to participate in the project or withdraw at any time without explanation, and further, that 
such action will in no way affect their future interactions with their PCP. If the patient 
remains interested in participating, they will be provided with a copy of the consent form to 
literacy issues, the RA will read and explain the consent him/her. Patients will be asked to 

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repeat back to the salient points of the consent form to make sure that they understand the 
study they are agreeing to participate in. Patients who exhibit any cognitive deficits will not 
be eligible to participate in this study. If the patient desires to participate, s/he will sign, and 
the RA will co-sign. Participants will receive a copy of the signed informed consent.  A 
second copy will be stored in a secure, locked filing cabinet in a dedicated room.  
The RAs on the project will have previous experience working on intervention trials and as 
part of this work have obtained informed consent from demographically diverse participants. 
Further, the RAs will be experienced with consenting Spanish-speaking participants. If the 
participants speak Spanish they will receive an IRB approved Spanish translated Consent 
form. The Spanish consent form will be explained by a Spanish-speaking RA. A modification 
will be submitted that contains only translated research materials, including the informed 
consent documents. 
6.3.3 Screening 
Trained RAs will be responsible for screening potentially eligible participants from the FHCs 
and FGPs. Once a potentially eligible patient is identified for this study, they will be screened 
by telephone using a standardized form that outlines the study's inclusion and exclusion 
criteria.  Study staff will obtain verbal consent prior to beginning the eligibility screening. 
Only participants that meet all eligibility criteria will be scheduled for a subsequent face-to-
face meeting to obtain written informed consent. 
6.3.4 Recruitment, Enrollment and Retention 

33 
Providers will be recruited through in-service talks at the clinics. Four methods, described 
below, will be employed to recruit the maximum number of eligible patient participants. 
Signed informed consent will be obtained from participants who meet the study eligibility 
criteria. 
Method 1: Recruiting Using EHRs through EPIC: We will use EPIC to identify potentially 
eligible patients seen in the FHC/FGPs, based on DRG codes indicating presence of type 2 
diabetes. We will develop a roster of potentially eligible patients for each treating physician 
in the practice.  Physicians will be asked to review the roster and indicate, for each patient, 
whether an intervention targeting tracking patient-reported outcomes via text messaging is 
appropriate. Lists of patients deemed appropriate (i.e., "yes") by the physician will be 
generated. Following permission from FHC/FGP treating physicians to recruit their patients 
to the study, patients will be approached and screened using the following process: (a) A 
letter signed by the treating physician and Dr. Schoenthaler will be sent to the treating 
physician's patients notifying them of the study, and informing that an NYULH clinical staff 
person will contact them to explore their willingness to consider participation, or that their 
patients can call directly to the study staff to ask about the study.  (b) Study staff will call or 
email patients who agree to be contacted, describe the study and, if the patient expresses 
an interest, conduct preliminary screening by telephone. Verbal consent is obtained by study 
staff prior to eligibility screening.  (c) For potentially eligible patients with active MyChart 
accounts that have agreed to be contacted for research and indicate yes under the 
“recruiting ok?” option on EPIC, study staff will send the already IRB approved email script 

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via Epic. The patient will receive the message via MyChart and it will automatically be noted 
on their EHR as an encounter message. (d) Written informed consent will be obtained with 
subsequent face-to-face visit for eligible participants. An IRB-approved waiver of 
authorization will be obtained prior to searching the EHR. 
Method 2: Participant self-referral through EPIC EHR MyChart alerts: We will provide 
the NYULH Epic Research Integration team with a list of potentially eligible patients 
provided to us by NYULH DataCore services through an IRB-approved waiver of 
authorization. The Epic team will create weekly reports on upcoming appointments from this 
potentially eligible patient's list, and will send these patients an alert notification two weeks 
prior to these appointments. These alert will inform patients to check MyChart electronic 
record for a new message. A modification will be submitted with the alert text prior to starting 
the study. 
We will provide a NYULH Epic Research Integration team with an IRB-approved patient-
facing script to be posted in the Epic electronic health record patient portal (MyChart) with a 
brief study description and encouragement to discuss the study with their treating physician 
on their next appointment. After this encounter, the Epic Research Integration team will send 
a second alert to potential participants after their medical appointment for them to check 
MyChart for another IRB-approved message reminding patients to contact study staff for 
any questions or to express their interest to participate. At this point, study recruitment 
proceeds as per protocol: (a) study staff describe the study and, if the patient expresses an 
interest, conduct preliminary screening by telephone. Verbal consent is obtained by study 

34 
staff prior to eligibility screening. (b) Written informed consent will be obtained with 
subsequent face-to-face visit for eligible participants. A modification will be submitted with 
the alert text prior to starting the study. 
Method 3: Self-referral from advertisements placed in the FHC/FGPs: IRB-approved 
fliers and brochures containing an overview of the study will be created and displayed in the 
clinical practice setting for those who may be interested. Interested patients will be provided 
with the phone number of the study staff that they may call to obtain additional information 
about the study. Those participants contacting the study office will be provided a brief 
description of the goals of the study and what their participation would entail. Those who 
remain interested will be screened to assure that they meet eligibility criteria and schedule 
an informed consent and eligibility visit. We will contact the patients' healthcare 
provider/agent to determine if their patient is fit to participate in the study.  A modification will 
be submitted with flyers prior to starting the study. 
Method 4: Physician referral: During the provision of routine ambulatory care, physicians 
will identify potentially eligible participants and ask about their interest in a study that 
proposes to examine how patient and providers talk about taking medications. Interested 
patients will be advised to contact the study by telephone to discuss possible enrollment. 
Interested patients will be provided with the phone number of the investigators that they may 
call to obtain additional information about the study.  Those participants contacting the study 
office will be provided a brief description of the goals of the study and what their participation 

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would entail.  Those who remain interested will be screened to assure that they meet 
eligibility criteria and schedule an informed consent visit.  
Retention Plan          
 We will use several strategies to retain practices and participants while they are enrolled in 
the trial. These include: (1) Signed memorandum of understanding (MOU): We have found 
that this formal agreement ensures that the sites understand the purpose of the study and 
their roles and responsibilities for participation, which increases the likelihood of retention. 
The MOU also highlights the benefits of participating in the project. All sites will be asked to 
sign this agreement as part of the recruitment and enrollment process. (2) Identify a practice 
champion or key contact to act as a liaison: This is also crucially important to ensure fidelity 
to the implementation of the MJS DIABETES intervention into the clinic workflow. (3) Offer 
monetary incentives for participation. For patients, this includes offering appropriate 
incentives (including cell-phone data plan subsidies), time to complete study visits, periodic 
phone calls, and transportation to the sites (total incentive: Formative phase: $
Efficacy trial: $50). PCPs in both phases will be offered an incentive of $50 for their time. (4) 
Maintain communication: For patients, following consent, we will request the names, 
addresses, and telephone numbers of two friends or relatives, so we can contact patients in 
the event of a missed appointment. This approach has been a helpful strategy in prior trials. 
We will implement additional strategies that have led to successful retention of racial/ethnic 
minority patients in clinical trials such as: provision of a toll-
flexible schedu

35 
study. We will also send reminders for upcoming study visits in the form of mailed letters, 
telephone calls, and secure messages sent through MyChart and doxcimity. For PCPs, we 
will maintain contact through an emailed newsletter for these sites that provides updates 
about national and statewide health care initiatives but does not discuss intervention-related 
information. We will also remind PCPs of the protocol at the monthly meetings. 
To increase enrollment into the study, all participants will also be asked about their ability to 
receive text messages during the consent procedures.  Those individuals who express 
concern about participating due to the fees associated with receiving text messages (due to 
either not having a text messaging plan or a limited allowance of messages per month) will 
receive reimbursement for the messages that are sent as part of the study. Patients who will 
accrue the most text messaging charges and do not have a text messaging plan will be 
reimbursed $25 in total. 
6.3.5 On Study Visits 
Screening Visit: During this visit, trained RAs will use a standardized form to screen 
patients based on the study's inclusion and exclusion criteria.  Verbal consent will be 
obtained prior to beginning the eligibility screening.  Only patients that meet all eligibility 
criteria will be scheduled for the face-to-face consent/baseline visit.  This visit should take 10 
minutes. 
Consent/Baseline Visit: At this visit, trained RAs will describe the study in easy-to-
understand language.  If the patient remains interested, the RA will obtain written informed 

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consent in the patient's preferred language (English or Spanish).  Following informed 
consent, patients will complete the baseline study measures (see Measures Table 7).  
Finally, patients will be randomized to the intervention or control arms.  This visit will take 
approximately 45 minutes. 
Follow-up study visits at 3, 6, and 9-Months (post randomization): Patients will 
complete self-report measures with a bilingual RA. Patients in the MJS group will also be 
asked about any challenges to using MJS since their last study visit.  The visit will be 
conducted either via telephone with a RA or REDCap, depending on the patient’s 
preference. These visits will take approximately 30 minutes each.  
6.3.6 End of Study and Follow Up 
Final study visit at 12-Months (post randomization): Patients will complete the self-report 
measures and have their chart review completed. Patients in the MJS group will also 
complete measures regarding perceived use, ease of use and use behavior. Patients will 
also complete an exit interview where they will be queried about their experiences using the 
MJS tool over the past 12 months and recommendations for improvements. The visit will be 
conducted either via telephone with a RA or REDCap, depending on the patient’s 
preference. This visit will take approximately one hour. 
In addition, providers will be asked to complete, measures regarding perceived use, ease of 
use, use behavior and physician communication at 12 months. Providers will also complete 
an exit interview where they will be queried about their experiences using the MJS-EHR 
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interface over the past 12 months and recommendations for improvements. The PCP study
visit will take approximately 30 minutes. 
 
 
6.4.2 Sample Size Considerations 
Formative phase: Sample size estimates for this phase are based on best practices for 
maximizing information power of qualitative research. Information power is determined by 
the specificity of the study aims, use of theory, and dialogue quality. It is recommended to 
begin with 4-8 participants and add to the sample, as needed to maximize information 
power. 
Clinical Efficacy Phase: Power calculations are based on comparable studies using mHealth 
solutions to improve clinical and patient-reported outcomes in patients with T2D. We expect 
a group difference of 0.6%-1.4% between MJS DIABETES and UC groups at month 12 as 
suggested in Baron et al. This study compared the effects of a mHealth intervention on 
HbA1c and PROs including health-related quality of life and depression among a sample of 
81 patients with T2D.  Based on this study, we assume that a SD of HbA1c is 1.6%. Using a 
two-sample t test, for 80% power and 5% type I error, we can detect a 0.6% group 
difference with n=113 per group. With that same sample size, we are able to detect a 0.3% 
reduction in HbA1c for the MJS DIABETES group at month 12 compared to baseline. An 
attrition rate of 20% will ensure that 282 patients (141 per group) complete the study and 

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have adequate data. This attrition rate is comparable to other clinic-based T2D trials in 
vulnerable populations. 
6.4.3.1 Primary Analyses 
Our analytic plan to achieve our outcomes at each phase is as follows:  
For the formative phase, focus groups will be transcribed (and translated in English) 
verbatim and coded using Atlas.ti. The analysis of the qualitative data from patient and PCP 
focus groups will be done in two parts: 1) A brief report of the predominant themes for 
immediate use in the design workshop, described below, and 2) content analysis of the 
sessions to be shared in future publications in order to advance the science on the use of 
PROs for diabetes management in primary care practices.  
For the brief report, Dr. Schoenthaler and a trained RA will conduct a debriefing meeting 
after each focus group to create a summary that outlines the key barriers, facilitators, needs 
and workflow preferences among patients and PCPs. After completing all 3 focus groups, 
the RA will calculate the mean importance ratings for each of the PROs discussed by the 
patients and PCPs. The study team will use the mean scores in concert with 
recommendations for selection of PROs in diabetes research outlined by Reaney et al. to 
identify the appropriate PROs that will be collected in the clinical efficacy trial. The brief 
report will drive the development of workshop materials and exercises (draft MJS content, 
workflow maps), as described below.  
For the content analysis, session transcripts will be analyzed by Dr. Schoenthaler and 

37 
consultant, Dr. Rosal, [who are experienced in qualitative research], using the constant 
comparison method. Specifically, the coders will independently review the transcribed focus 
groups to identify themes related to the design of the MJS intervention for English and 
Spanish-speaking patients, and PCPs, and barriers and facilitators to uptake. The coders 
will iteratively develop a codebook during this process to maintain coding consistency and 
transparency in coding decisions. Discrepancies in coding will be resolved through an 
interactive process of re-
the codebook will be updated to reflect any changes. Assessments of inter-rater agreement 
will be calculated using Krippendorff's alpha to ensure an acceptable level of agreement is 
reached (>0.80) between the coders.  To evaluate the usability of MJS DIABETES, we will 
follow best practices for instant data analysis (IDA) of usability data. After each session, the 
study team will meet to brainstorm the usability and workflow issues (e.g., content, 
readability, navigation, alerting and visualizations) that were observed. Each identified issue 
will be then categorized as either: critical (unable to complete the task), severe (significant 
delay or frustration in task completion), or cosmetic (minor issue). Each of these issues will 
be mapped onto the transcribed audio and screenshots captured during the sessions to 
provide specific and detailed recommendations for refinement of the MJS mobile platform 
and EHR interface before proceeding to the next testing session. After completing all of the 
sessions, we will conduct affinity mapping to identify the major issues that were causing 
critical and severe errors in the testing sessions. This inductive process involves 
aggregating the separate issues identified in the brainstorming sessions into larger themes 
related to usability and workflow of MJS DIABTES. This creates a more synthesized and 

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comprehensive understanding of the most severe and frequent issues that must be 
addressed before testing MJS DIABETES in the RCT. Previous research have shown that 
using IDA can reduce the amount of time needed for analysis by 90%, while achieving 85% 
overlap in identifying critical usability issues compared to traditional qualitative analytic 
methods. The primary output of this step is the fully functional, well-integrated MJS 
DIABETES intervention for testing in the clinical efficacy trial. 
For the clinical efficacy phase, the primary analysis is intent-to-treat (ITT). For the ITT 
approach, all patients that are randomly assigned to the intervention or UC groups will be 
included in the analysis, regardless of program and evaluation compliance. The primary 
outcome is the mean reduction, compared to baseline, in HbA1c at 12 months in the MJS 
diabetes intervention vs. UC arm.  HbA1c will be treated as a continuous variable in this 
analysis. We will test the treatment X time interaction in a random effects linear regression 
model to test the time-specific differences in HbA1c at 12 months attributable to the 
intervention. We also will use the "lincom" command in Stata to estimate differences in time-
specific changes from baseline. In additional analyses, we will adjust for covariates (e.g., 
ethnicity, gender, age, income, education, employment, insurance) unbalanced between the 
treatment arms at baseline at p=0.10. 
6.4.3.2 Secondary Objectives Analyses 
For secondary aim 1, analyses will examine the intervention effect individually on each self-
care behavior and as a summary score at 12 months. The measures will be treated as 
continuous variables. As with the primary aim, we will test the treatment X time interactions

38 
continuous variables. As with the primary aim, we will test the treatment X time interactions 
in a random effects linear regression model to test the time-specific differences in each of 
the individual self-care behaviors, and the summary score at 12 months. The "lincom" 
command in Stata will be used to estimate differences in time-specific changes from 
baseline.  Adjustments for covariates will be made if randomization does not produce 
balanced groups. We will also estimate the proportion of patient and PCP use of MJS 
DIABETES as defined by number of PROs answered, error messages received, response 
times, number of EHR PRO reports accessed, clicks within the EHR PRO report, and 
retention rates over the 12-month study to calculate mean, median and standard deviation. 
We will perform statistical modeling to determine the direction and degree of association 
between change in PROs and change in the primary and secondary outcomes.  
For secondary aim 2, we will estimate a just-identified path model using the robust weighted 
least squares estimator to investigate relationships among the theoretical mediators of 
diabetes knowledge, self-efficacy, and outcomes expectation and patient-provider 
communication and the adherence and HbA1c outcomes, Based on our conceptual model, 
we will test the direct effects from the theoretical constructs to the self-care behaviors 
(individually). In addition to the direct effects, the indirect effects from each variable to 
HbA1c via adherence will be estimated as the product of component direct effects and 
tested using bootstrapped 95% confidence intervals. Finally, we will estimate the direct 
effects of the predicted model of adherence on HbA1c reduction. Predicted probabilities of 
the secondary outcomes and HbA1c will be calculated from path model coefficients to 
elucidate the magnitudes of direct and indirect effects. 

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6.4.3.3 Safety/Pregnancy-related policy 
Patients who are pregnant or planning to become pregnant in the next 12 months are 
excluded from this trial. 
6.4.3.4 Analysis of Subject Characteristics 
Baseline characteristics and outcomes will be summarized descriptively using mean values 
and standard deviation or frequency descriptions.  During preliminary analysis, we will also 
examine: (1) comparability of treatment arms at baseline (based on Chi-squared statistics or 
t-tests, as appropriate) based on participant characteristics, (2) relationships between the 
response variables and potential covariates, and (3) predictors of missing data/drop-out. We 
will document any observed reasons for missing data during data collection.  
6.4.3.5 Interim Analysis (if applicable) 
Not applicable 
6.4.3.6 Health economic evaluation 
Not applicable 
6.4.5 Handling of Missing Data 
Univariate statistics and missing value analysis modules will be used to check the number 
and pattern of missing. We will use Little test to check the assumption of missing data 
completely at random (MCAR) or missing at random (MAR). Identified predictors of missing 
data will be included as covariates in a random effects framework, to provide unbiased 
f
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39 
estimates of the intervention effect under an assumption of MAR (i.e., missingness depends 
on observed covariates but not on unobserved covariates). We will conduct sensitivity 
analyses to assess departures from this assumption. 
 
 

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7 - Trial Administration 
7.1 Ethical Considerations 
This study will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki. 
To mitigate any breaches in security or privacy as it relates to the MJS DIABETES 
intervention, we will adhere to policies by the Federal Office of the National Coordinator for 
Health IT as well as the principles of the Markle Framework for Networked Personal Health 
Information and the technical specifications of the O-Auth protocol for user authentication. 
Based on these sources, the Privacy and Security Plan will include: 
 
Development of explicit policies governing the access to individual PRO data in the 
MJS intervention (e.g., limited to study staff who require it for authorized, legitimate, 
and documented purposes). 
 
A firm policy prohibiting the study staff or consultants (i.e., Rip Road, Dr. Rosal) from 
access to individual patient health records, except for specific purposes of research 
approved by the IRB. 
 
Encryption of all sensitive user data within the MJS mobile platform and EHR 
interface to prevent unauthorized access and disclosure in the case of a physical 
loss. No PHI will be collected on the MJS platform. 

40 
Regular training and reminders sent to study staff and consultants about system 
security and the need to follow related protocols to protect the confidentiality of user 
information. Policies will also be established for handling violations to security 
protocols, if they arise. 
 
A protocol outlining regular risk assessments and system audits to ensure a secure 
transmission of patients' data, including use of encryption protocols such as Secure 
Socket Layer (SSL) technology. 
As part of their participation in this study, patients and providers will receive a small amount 
of payment to reimburse them for their time and effort. The payment is needed to reimburse 
patients and providers for the additional travel to the FHC/FGPs for study visits and 
additional time to participate.  
7.2 Institutional Review Board (IRB) Review 
This study will be overseen by the NYU School of Medicine Institutional Review Board. All 
research staff will have completed and passed IRB and HIPAA training and will be 
thoroughly trained in appropriate consent procedures and the need to maintain strict 
confidentiality. All research protocols will be reviewed and approved by the IRB prior to 
gaining access to protected health information and subject recruitment 
7.3 Subject Confidentiality 
As part of the process involved in obtaining written informed consent, all patients/PCPs will 
be reminded that their responses are confidential and that they may refuse to participate in 

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the project or withdraw at any time without explanation, and further, that such an action will 
in no way affect their future interactions with the FHC or FGP. To ensure confidentiality, data 
will be associated with an individual participant only by an assigned identification number, 
the code for which will be kept in a locked drawer. Only members of the research team will 
have access to the participants' personal information file.  All computers containing 
confidential data will meet security requirements established by the HIPAA Security Rules, 
and established by the Office of Management and Budget (OMB) in OMB Circular No. A-
130, Appendix III - Security of Federal Automated Information Systems. Specifically, all 
electronic interview data will be saved on a secure server housed by NYULMC and backed 
up daily or weekly depending upon the receipt of data. PHI will be confined to a secure 
server that is not connected to the Internet. All computers will be password protected and on 
a private LAN network. No file and database servers are accessible to the public through the 
Internet. Prior to inclusion in any data set (internal and external), data will be stripped of all 
identifying information.  
Since text messages will be transmitted in this study, a variety of measures will be used to 
reduce information security risk. Patients' text responses will be securely handled via Rip 
Road's HIPAA compliant hardware infrastructure. Rip Road follows a set of well-developed 
policies and procedures vetted by top healthcare organizations in the management and 
protection of all data tracked through MJS. Patient information will be de-identified for 
administrative views and for analysis within the Rip Road system. Text messages will not 
identify patients as having a specific disease or include any PHI such as patients' name. 
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Patients will be informed that their data are stored, without identifiers, in the highly secure 
HIPAA-compliant Cloud.  They also will be informed that there is a remote possibility that the 
Cloud or their mobile account could be hacked and that information about study activities 
(communications, recorded behaviors) could be disclosed.  However, these data are not 
sensitive in nature. Devices will be configured with a participant ID and no other personal 
identifiers. It is possible that a participant could lose their mobile phone or leave it in a public 
location with the screen turned- on, enabling others to view personal information.  To 
address this, we will assist the participant in enabling a screen saver that is activated when 
the mobile phone has been idle for 5 minutes, as well as a 4-digit password that must be 
entered each time the device is turned-on. They will also be instructed on how they can turn 
off home screen notifications if they choose to. Finally, all study staff will be trained in the 
NYULMC Research Practice Fundamentals, which include training in issues of 
confidentiality and requires trainees to sign a confidentiality agreement. 
7.4 Deviations/Unanticipated Problems 
If any protocol changes are needed, the Principal Investigators will submit a modification 
request to the IRB.  Protocol changes will not be implemented prior to IRB approval unless 
necessary to eliminate apparent immediate hazards to the research subjects. In such a 
case, the IRB will be promptly informed of the change following implementation (within 10 
working days). 
 
 

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7.5 Data Quality Assurance 
In accordance with procedures for Good Clinical Practice, the PI will be responsible for data 
quality control including reviewing protocol compliance, data collection and verification. Data 
will be reviewed monthly. 
Since assessment data is all entered electronically, accuracy and completeness of the data 
is maximized through alerts and pop-ups if the data is inconsistent, out of range, or not 
entered.  The data entry procedures include a secure intra-net log-in that is password 
protected and data entry will have data quality checks with the electronic data system. 
Outcome measure data that involve questionnaire responses are collected in the secure 
REDCap. Exit interview data will be collected via either a telephone interview with the RA or 
through REDCap, depending on the patient’s preference. Safety data are collected in a 
separate database related to each participant.  
At the outset of the study, an investigator meetings will be held to introduce investigators 
and study personnel to the study protocol, data collection forms, procedures and regulatory 
requirements. During the course of the study, the program coordinator will make routine site 
visits to review protocol compliance, compare data collection forms  with individual subject's 
original source documents, assess test material accountability and ensure that the study is 
being conducted according to the pertinent regulatory requirements. The review of the 
subject's medical records will be performed in a manner to ensure that subject confidentiality 
is maintained. 
7 5 1 D t
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42 
7.5.1 Data Collection
Data collected in the study are divided into four categories: (1) outcomes, (2) covariates, (3) 
mediators, and (4) process measures. The measures table 7 provides information on the 
measure to assess each variable and timing of administration. All measures will be obtained 
by a trained RA using a standardized procedure. With the exception of the process 
measures, measures will be the same for both arms. 
Da
information kept under lock and key, and supervised by a designated high-level staff 
member. None of the analyses will permit individual identification. Only ID numbers will be 
used for communication with the RAs in the event of data anomalies. The clinical/research 
barrier will remain intact, in that it will not be necessary for the data-processing staff to know 
the identity of the participants. 
7.5.1.1 Access to Source 
(e.g., date of birth) that are necessary for analyses may be entered as part of the data set. 
Certain rules obtain for handling PHI: a) copies of hard copy data will be hand-delivered in a 
sealed envelope marked confidential (e.g., via messenger or directly by the RA) or sent via 
-encrypted electronic data, e.g., lab values will be accessed using 
a project-specific password or uploade
submission or upload to the NYU server, all data containing PHI will be encrypted using 
PGP or Silver Key encryption software (e.g., assessment data). PGP and Silver Key ensure 

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data safety by requiring dig
access to fax transmissions. This secure fax machine is housed in a locked area. All project 
related fax transmissions will contain a confidentiality notice. 
7.5.1.2 Data Storage/Security 
Hard copy data and log sheets are kept in a locked storage area behind a locked, alarmed 
door. Electronic data will be backed up daily or weekly depending upon the frequency of 
receipt/ entry. The backup disks will be stored in a fireproof safe in a different location. All 
computers are password protected and are on a private LAN network. There are no servers 
that are accessible to the public through the Internet. A hardware-based firewall separation 
protects against hackers and unauthorized access to all electronic data not maintained on 
the server, providing protection against viruses, worms and Trojan horses transmitted over 
the Internet. The firewall contains anti-virus software (McAffee Anti Virus) to protect the 
network from threats of viruses contained in email attachments. Through "push-technology" 
this anti-virus software is automatically updated for all virus definitions and other updates. 
Secure internet communication is established through a VPN tunnel which is configured 
through the firewall. 
7.6 Study Records 
Study records will include all regulatory documents, protocols, consents forms, data 
collection forms, subject medical records, surveys, and transcripts from audio-taped 
interviews and video-recorded usability sessions. 

43 
7.6.1 Retention of Records
In accordance with 45 CFR 164.530(j)(1) of HIPAA, research records including signed 
consent forms that contain the HIPAA authorization will be retained for 6 years after the date 
on which the subject signed the consent form or the date when it last was in effect, 
whichever is later.  In addition, we will maintain records of IRB activities for at least three 
years after completion of the research (45 CFR 46.115(b)). 
7.7 Study Monitoring 
The PI will be responsible for monitoring the study.  As noted in the Data Safety Monitor 
Plan, the PI will monitor the study activities along with a designated medical monitor, internal 
committee and IRB.The PI will review the study for protocol compliance, data collection and 
verification on a monthly basis. 
7.8 Data Safety Monitoring Plan 
The purpose of the data safety monitoring plan (DSMP) is to ensure the safety of 
participants and the validity and integrity of the data. Personnel involved in the monitoring 
activities will include: 
 
The PI 
 
Designated medical monitor (a physician in our program who will provide 
consultation on medical risks and who will review adverse events) 
 
Internal Committee (The PI and the Co-Investigators on the present proposal) 

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Institutional Review Board 
The PI will be responsible for quality control including reviewing protocol compliance, data 
collection and verification. Data will be reviewed monthly. Specifically, the plan will comprise 
the following elements: 
 
Monitoring participant recruitment and retention rates and developing a database 
tracking system to ensure there is no differential attrition by race/ethnicity, age, or 
gender 
 
Ensuring patient confidentiality through the use of unique identifiers.  In addition, all 
data will be saved on a secure server housed by NYU Langone Health and backed 
up daily or weekly depending upon the receipt of data. PHI will be confined to a 
secure server that is not connected to the Internet. All computers are password 
protected and on a private LAN network. Only IRB-approved study staff will have 
access to the data. No file and database servers are accessible to the public through 
the Internet. Prior to inclusion in any data set (internal and external), data will be 
stripped of all identifying information.  Finally, we will obtain a Certificate of 
Confidentiality. 
 
Reporting of adverse events to the IRB and to AHRQ/Merck: Adverse events will be 
reported to the New York University IRB. Summaries of adverse events reports will 
be made to AHRQ/Merck in the yearly progress or report or, at the end of year 2, in 
the final report, unless the nature of a particular event is such that it bears immediate 

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reporting to AHRQ/Merck. 
 
A detailed plan to address serious events that may arise such as increased anxiety 
while taping interactions that may include sensitive information, survey assessments, 
or patient hyper- or hypoglycemia. The plan will include a step-by-step algorithm to 
deal with such events. The Principal Investigator will monitor the data and conduct 
safety reviews, at a specified frequency appropriate to the level of risk (every 3 
months).  
 
Procedures for protocol adherence and deviations.  If any protocol changes are 
needed, the PI will submit a modification request to the IRB.  Protocol changes will 
not be implemented prior to IRB approval unless necessary to eliminate apparent 
immediate hazards to the research subjects. In such a case, the IRB will be promptly 
informed of the change following implementation (within 10 working days). 
 
Statistical review of the study will be conducted by the study statistician at the 
conclusion of Year 4. Interim analyses will be performed after half of the eligible 
sample has been randomized and completed the final study visit. However, if a 
serious adverse event occurs as a result of the study, consideration will be given to 
stopping the study early. In the event of early stopping of the study, the IRB will be 
promptly notified. 
7.9 Study Modification 

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The study may be modified or discontinued at any time by the IRB, AHRQ, Merck, or other 
government agencies as part of their duties to ensure that research subjects are protected. 
If any protocol changes are needed, the PIs will submit a modification request to the IRB.  
Protocol changes will not be implemented prior to IRB approval unless necessary to 
eliminate apparent immediate hazards to the research subjects.  In such a case, the IRB will 
be promptly informed of the change following implementation (within 10 working days). 
7.10 Study Discontinuation 
The study may be discontinued at any time by the IRB, AHRQ, Merck, or other government 
agencies as part of their duties to ensure that research subjects are protected. If a serious 
adverse event occurs as a result of the study, consideration will be given to stopping the 
study early. In the event of early stopping of the study, the IRB will be promptly notified. 
7.11 Study Completion 
The estimated completion date of this study is 08/31/2023. At that time, a progress report 
will be submitted to the IRB and the record will remain open for analysis of study data. Once 
all research-related interactions with participants are completed and collection and analysis 
of identifiable private data (as described in the IRB-approved protocol) are finished, the 
study will be closed with the IRB.   
7.12 Conflict of Interest Policy 
All study team members will complete a financial disclosure form. In the event a conflict that 
requires disclosure or management is identified, the PI will provide to the IRB in writing with 

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a summary of conflict and the conflict management plan. 
7.13 Funding Source 
This project will be funded by the AHRQ and Merck & Co., Inc. 
7.14 Publication Plan 
Publication of the results of this trial will be governed by the policies and procedures 
developed by the PI and study team.  Any presentation, abstract, or manuscript will be made 
available for review by AHRQ and Merck prior to submission.