A Pilot Trial of the Feasibility of a Patient-Centered Mobile Health Self-Management Support Tool for Healthy Behaviors (SMART-HABITS) in Chronic Kidney Disease
Phase: NA
Conditions: Renal Insufficiency, Chronic, Hypertension
Sponsor: University of Pennsylvania

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
1 
Protocol Template for Human Subjects Research  
without an Investigational Product 
 
 
 
 
Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
Principal Investigator  
Sarah Schrauben, MD, MSCE 
Department of Medicine and Epidemiology 
930 Blockley Hall, 324 Guardian Dr, Philadelphia, PA, 
19103 
267-324-7588 
sarahsch@upenn.edu 
 
 
Funding Sponsor 
 
NIDDK/NIH 
Date 
April 2, 2021 
 
NCT Number 
04858295 
 
 
 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
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1. Background Information and Rationale 
1.1 Introduction 
The escalating burden of chronic kidney disease (CKD) and end-stage renal disease (ESRD) is widely acknowledged, 
and thus kidney disease presents itself not only as a very potent cause of mortality and morbidity but also as a serious 
economical challenge around the world, which makes it necessary to optimize its management.1,2 Currently, the 
management of CKD includes extensive participation in self-management behaviors, including monitoring blood glucose 
and blood pressure, maintaining physical activity, changing eating patterns, adhering to complicated medication regimens, 
and avoiding nephrotoxins, in the effort to slow kidney disease progression and reduce adverse outcomes.3 
 
However, CKD patients demonstrate high rates of non-adherence to self-management, leading to increasing costs, 
morbidity and mortality, and overall poor outcomes, which presents a compelling need to better understand how to help 
this population self-manage the disease.4 To improve self-management, it is to develop core self-management skills, 
which include problem-solving, decision making, action planning, goal-setting, seeking social support, and resource 
utilization, as well as to explore factors related to engagement.5,6 In other chronic diseases, important influences of 
engaging in self-management include improved knowledge, self-efficacy (or the confidence in their ability to overcome 
barriers in order to perform self-management behaviors7-13), and social support.14-19 Individuals with CKD have also 
identified similar factors as important to them for self-managing.20 
 
Therefore, effective self-management support that improves self-efficacy, knowledge, and social support could ultimately 
improve engagement in self-management behaviors in pre-dialysis CKD, which could then favorably influence the course 
of the disease.21 The Institute of Medicine defines self-management support (SMS) as “the systematic provision of 
education and supportive interventions to increase patients’ skills and confidence in managing their health problems, 
including regular assessment of progress and problems, goal setting, and problem-solving support”.22 SMS is recognized 
as widely effective across numerous chronic conditions, and a meta-analysis of SMS programs found improved clinical 
outcomes.23 The benefits of SMS in kidney disease is growing, although most programs have focused on ESRD, which 
have led to improvements in disease specific and self-care knowledge, health-related quality of life, health service 
utilization, progression and understanding of CKD, and increased physical activity.24-33 Participants of SMS programs also 
report finding them helpful and those who have not yet participated in such a program express interest and willingness to 
participate, and learn how to self-manage.34-36 
 
The use of digital technology to support chronic disease self-management is growing, as advances in technology have 
made real-time assessments of health behaviors and their influences possible with minimal respondent burden.29,37 An 
example of one of these digital solutions is mobile health (mHealth) technology, the use of mobile and wireless devices to 
enhance health and wellness by extending health interventions and research beyond the reach of traditional clinical 
care.38 Recent studies that have examined mHealth tools across various diseases have shown significant improvement in 
medication adherence, weight management, HbA1c, stress levels, smoking quit rates, and self-efficacy, as well as high 
level of patient satisfaction, and levels of familiarity with mobile technology.39-43  
 
Therefore, mHealth technology offers an attractive and novel tool to support CKD patients integrate self-management into 
their lives through a SMS program. Specifically, the smartphone is an especially attractive option for SMS and remote 
monitoring due to their ubiquity, connectivity, computational power, portability, and relatively low cost.44-46 According to a 
Pew Research Center Survey conducted in November 2016, 90% of US adults own a cell phone and nearly 77% of all 
Americans own a smartphone, including 64% among lower income Americans, 74% those aged 50-64 years and 42% of 
those 65 and older.47 Smartphones can collect data for purposes such as patient monitoring, reminders, and 
recommendations, as well as offer additional functionality offered by their built in devices and connection with other 
devices.  
 
The planned intervention, entitled, Supporting Self-Management of Healthy Behaviors in  (SMART-HABITS), aims to 
provide SMS for CKD patients by providing text messages delivered as motivational reminders and support to encourage 
blood pressure self-monitoring and physical activity monitoring, and will also provide access to educational resources and 
opportunities to engage in social support.  The SMART-HABITS intervention will undergo feasibility testing in a single 
group prospective trial within a renal clinic affiliated with the Division of Renal-Electrolyte and Hypertension within the 
University of Pennsylvania Health System.  
 
1.2 Name and Description of Intervention 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
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Altogether, SMART-HABITS aims to increase self-efficacy, disease-specific knowledge and social support via mHealth 
through the Way to Health Platform in order for CKD patients to enhance self-management and its core skills. The 
coupling of mHealth technology and SMS is novel, innovative, and potentially cost-effective. Although various mHealth 
interventions have been developed across a spectrum of chronic illnesses with promising results48-53, there have been few 
such applications to support health behaviors in patients with CKD, of which have primarily focused only on a single 
component of self-management.54-56 Expanding on this,, SMART-HABITS encompasses multiple behavior change 
techniques, and is centered in the Health Belief Model and the Social Cognitive Theory in order to foster behavior change 
and improve self-management.18,57-62 
 
A critical component to the success of any mHealth program is the willingness and ability of the target population to adopt 
and effectively utilize the technology. The attitudes towards mHealth have been assessed in other chronic diseases46,63-66, 
but there has been limited data on those with kidney disease, which has been primarily assessed only in kidney in 
transplant recipients. Among kidney transplant recipients, interest in receiving CKD education and SMS through mHealth 
has been confirmed through focus groups, and surveys, and kidney recipient participants of an mHealth intervention were 
comfortable using mobile phones and being monitored using mobile technology, with many of already owning and using 
smartphones.67-69 In order to improve the SMART-HABITS program, it is important to understand and consider patients’ 
opinions and preferences, we plan to perform semi-structured interviews with participants at the end of the study for 
further refinement of the program.  
 
SMART-HABITS is intended to be delivered outside the clinical encounter and employ accessible technology to empower 
patients diagnosed with pre-dialysis CKD to manage their condition by enhancing knowledge of CKD through low literacy 
education materials, support engagement in self-monitoring of blood pressure, increasing participation in physical activity 
or weight loss through customized task prompts via text message, and promote social support through accountability 
sponsors and linked to community resources as described in the following sections.  
 
Within SMART-HABITS’ smartphone web-based application, there will be a portal which:  
- 
Provides educational information that incorporates both clinical and lay-experiential CKD knowledge 
- 
Displays personally set goals and real-time progress to goals 
- 
Links to social support  
 
The following sections further describe the components of the program:  
 
1) Education: informational content on CKD related health risks, self-management behaviors to slow progression of 
disease and prevent complications; provide examples of how everyday lifestyle activities can impact CKD.  
• 
The education section in the web-based application will include the following sections: 
General Information about Kidney Disease 
 
1. Kidney Disease and Manage You Kidney disease: https://www.youtube.com/watch?v=M8kbD4mgxFA 
2. Detect and Manage Your Kidney Disease: 
https://www.youtube.com/watch?v=ZhWHpJN3KaY&feature=emb_logo 
3. Trustworthy Information about Kidney Disease: https://www.niddk.nih.gov/health-information/kidney-
disease/chronic-kidney-disease-ckd 
4. High blood pressure and Kidney Disease: https://www.kidneyfund.org/prevention/are-you-at-risk/high-blood-
pressure.html 
5. Diabetes and Kidney Disease: https://www.kidneyfund.org/prevention/are-you-at-risk/diabetes.html 
 
Tips for Checking your blood pressure at home 
 
1. https://www.youtube.com/watch?v=6oYUYcK57Kc 
 
 
Tips about Physical Activity 
1. Health Benefits of Physical Activity: https://www.nia.nih.gov/health/real-life-benefits-exercise-and-physical-activity 
a. If also have diabetes: https://www.youtube.com/watch?v=z-UfMvBoGVU 
2. Daily Physical Activity Goals: https://www.youtube.com/watch?v=xBCgB8EvzYo 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
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3. Examples of exercise and physical activity: https://www.nutrition.gov/topics/exercise-and-fitness/exercise-
examples-and-videos 
 
 
 
2) Developing Goals and Action plan: setting personalized goals for blood pressure self-monitoring and physical 
activity 
• 
Patients will complete a patient-generated “action plan” to assist in developing goals to help them initiate changes 
and achieve success in managing their condition effectively 
o 
Develop goals for blood pressure control by the end of the study and the level of adherence to blood 
pressure measurements  
o 
Develop daily step count goal for physical activity over the study period 
 
3) Support Adherence and Increase Self-efficacy: 
• 
Provide personalized daily and weekly texts to encourage participation and progress towards blood pressure 
monitoring, physical activity goals 
• 
For blood pressure readings that are texted to the Way to Health platform,the participant will receive predefined 
comment on the control of their blood pressure 
• 
For each daily step count transmission, the participant will also received similar feedback  
• 
Additionally, if the participant elects to enroll an accountability sponsor, progress will be shared with this individual 
 
4) Monitoring:  
• 
For the participants using the OMRON Connect app, self-monitoring will be captured by electronically recording 
blood pressure measurements via Bluetooth by participant using a wireless blood pressure device (OMRON 5 
series cuff) 
o 
CKD patients will be asked to self-measure blood pressure using a blood pressure cuff at home at least 3 
times per week and then further personalized by goal-setting  
• 
Remote monitoring of physical activity will be done via a physical activity sensor (Fitbit Inspire 2) that is worn as a 
watch and link the data to the Fitbit app in order to help patients monitor their own personal progress. 
 
5) Social Support:  support through kin/sponsor 
• 
As indicated above in supporting adherence, by sharing feedback and progress with family members, peers 
or any other identified sponsor/support aims to support adherence.  
• 
In addition, there will be a link provided to the available social support: 
o 
Peers Lending Support- free, anonymous phone calls with other CKD patients 
(http://www.kidney.org/patients/peers/index.cfm) 
• 
Participants will also be provided with directions to access friends and a community with the FitBit App.  
• 
 
 
1.3 Relevant Literature and Data 
At all stages of CKD is a massively increased risk of CVD and associated events and early death.70 Hypertension is a 
leading caused of cardiovascular disease events. Hypertension is an asymptomatic but dangerous condition, which 
carries risk of catastrophic cardiac, renal and cerebrovascular events. However, commonly, it is inadequately controlled. 
There is evidence that self-monitoring of blood pressure at home is useful in improving medication adherence, and 
controlling BP.71-73 A previous systematic review of randomized controlled trials demonstrated that SBP readings in people 
undertaking home monitoring was significantly lower than control patients.74 Further evidence suggests that greater 
reductions in BP may be achieved by the addition of behavioral support for self-monitoring.75-77 This may be further 
facilitated when combined with efficacious lifestyle changes, such as increasing physical activity78,79, or weight loss.  
Physical inactivity is also leading risk factor for CVD80-82 , and it has also been suggested that it contributes to the 
development of CKD in the general population.83 However, higher levels of physical activity can lower all-cause 
mortality84,85, CAD80,49586, diabetes87, lower rate of nephropathy88 and renal dysfunction89,90 in diabetic patients, and weight 
gain91, and  weight loss is associated with cardiovascular health benefits92,93, reduction in the incidence of diabetes by 
50%94,95, and lowering of systolic blood pressure1.0-2.4 mmHg96. Additionally, two studies suggest that weight loss is 
beneficial for renal function97,98 but there is insufficient evidence that it affects CKD progression. These findings along with 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
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others provide evidence that reducing multiple risk factors concurrently, rather than targeting single factors, is likely to 
deliver greater reduction in cardiovascular disease events99.  
 
Telehealth is being increasingly used to assist patients and healthcare professionals responsible for their care to monitor 
medication conditions. A variety of delivery methods are available, from web-based methods to telephone touch pads.100 
Increasingly, widespread access to the Internet and mobile phones means that healthcare digital interventions are 
accessible to the majority of patients and can be used to provide information and support at any time the patient needs 
it.101  Ehealth/mHealth can empower patients by providing better access to personalized information and support for active 
involvement in treatment and self-management. A large meta-analysis found a small but significant positive effect of 
digital interventions on health-related behaviors102, while a Cochrane review found evidence that computer-based health 
interventions for those with chronic health conditions significantly improved knowledge, health behaviors, and clinical 
outcomes.103 Therefore, this intervention program has been developed to incorporate previously identified effective 
intervention components (self-monitoring, and behavioral support).  
 
• 
Rationale for inclusion of an education component: There is a low baseline understanding of CKD health 
risks. Increasing knowledge of CKD is a critical pathway to ensuring that patients can be taught how to integrate 
self-management activities and participate in care decision and planning.104 For example, patients need to be 
taught that maintaining appropriate blood pressure readings105, blood glucose control and taking their medication 
as prescribed all work together to protect kidney health106. Research has shown that patient understanding of 
CKD improves self-management and outcomes.107-110 Conversely, CKD patients who have a poor understanding 
on their disease process tend to participate less in their health care management.111 Additionally, CKD patient 
education programs may improve overall mood and feelings of good health110 and many patients desire CKD 
education.36,112,113  
 
However, simply providing information is not sufficient for behavior change and people may struggle to integrate this 
information into their lives.114 The following components were guided by health behavior theory to further bolster behavior 
change: 
 
• 
Rationale for inclusion of goal-setting and action planning:  
o 
Developing core self-management skills, such as action planning and goal-setting is central to improving 
adherence to self-management behaviors.5 A systematic review of SMS programs that used health 
information technology revealed that goal-setting was among the successful solutions, which also 
included education, monitoring, and collaboration.115  
• 
Rationale for inclusion of adherence support:  
o 
Follow up prompts have been associated with increased effectiveness.62 Previous studies have indicated 
that patients with higher self-efficacy have improved problem solving, open communication, and patients-
provider partnership.11,116-118 Increased self-efficacy has also been shown to be correlated to engagement 
in self-management behaviors, and improved outcomes (i.e., health status, decreased hospitalizations, 
improved QOL in dialysis patients).8,10,11,116,117,119-125 
• 
Rationale for monitoring:  
o 
Self-monitoring is a component of effective behavior interventions.61,126 Other chronic disease studies 
found that electronic self-documentation of blood sugars and weights, as in diabetes and heart failures, 
respectively, was shown to be an effective strategy to promote self activation.127,128  
o 
Remote monitoring via mobile phones has been shown to be an effective and sustainable strategy for 
improving health outcomes, increasing adherence to medical regimens and reducing costs in some 
chronic illness.42,44,128-131 
• 
Rationale for inclusion of social support:  
o 
As trusted sources of information, family and community members have the potential to help overcome 
sociocultural barriers and institutional/medical mistrust, which is prevalent among those with a large 
burden of CKD.132 In CKD, family, friends, and other social groups provide practical and emotional 
support and facilitate self-management (e.g., changing dietary patterns, increasing physical activity).133-136 
The Internet has also become a resource for the development of social support systems for those 
affected by chronic diseases, including kidney disease.137 
o 
The Internet has also become a resource for the development of social support systems for those 
affected by kidney disease, and an analysis of online discussions revealed patients are actively 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
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discussing CKD on social media.137,138 CKD patients have reported they desire social support139 but are 
unsure of available support and wish that SMS programs included information about local, community-
based resources, organizations and support groups.140 
 
2. Study Aims and Research Questions 
The primary aim is to assess the feasibility of using a smartphone-based behavioral intervention, SMART-HABITS, to 
support self-management of individuals with pre-dialysis CKD patients.  
 
Research Questions: 
- 
Will patients with CKD adopt SMART-HABITS? 
- 
Will patients with CKD adhere to prompts of the SMART-HABITS intervention? 
- 
Will patients with CKD wear and use wearable remote sensors (i.e. wireless blood pressure cuff and physical 
activity sensor)? 
- 
How many patients with CKD will drop out throughout the study period? 
- 
Is SMART-HABITS acceptable to patients? 
- 
What are patient views and experiences of using SMART-HABITS? 
- 
Is there any change in blood pressure control throughout the study period? 
- 
How well did participants achieve their step count goals throughout the study period? 
- 
Did SMART-HABITS associate with improved self-efficacy, knowledge, attitudes to mHealth, self-management, or 
quality of life? 

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3. Investigational Plan 
A cross-over prospective trial of feasibility of a smartphone-based behavioral intervention in a real-life setting.  
 
General Schema of Study Design 
 
 
 
 
 
Nephrology Practices: PCAM and Presbyterian 
Identification of Potential Participants(48-72 weeks): 
- 
Letter of invitation sent by research team after reviewing schedule for follow up visits, followed 
by phone call 
- 
Study advertisement posters within the practice 
- 
Pre-Screen all eligible patients who respond to invitation or inquire about poster 
Conducted remotely through Way to Health: Baseline consultation and enrollment:  
- 
Screening survey: Assess eligibility 
- 
Informed Consent 
- 
self-reported height, weight  
- 
Patients given unique log-in for Way to Health  
- 
Patients provided with instructions with how to use wearable devices (BP cuff and FitBit) 
- 
Provide authorization for data to be shared from wearable devices 
- 
Complete survey questions 
Intervention (12 weeks)  
- 
Arm 1 (first 6 weeks): Text message reminders to check BP and text BP readings to 
research team 
o 
Tailored text message feedback for transmitted BP readings 
- 
Arm 2 (first 6 weeks): push notification reminders via OMRON Connect app on 
participant’s phone to check BP and BP readings shared via OMRON app 
- 
Start of week 7: Arms cross-over 
- 
All participants: 
o 
Personal dashboard with access to educational and social support 
resources 
o 
Daily text message reminders and feedback for step count data 
o 
Re-engagement protocol for low participation 
o 
Weekly feedback on BP monitoring adherence 
Outcome assessments (end of 12 weeks) 
- 
Primary outcome assessments of adoption, adherence, and acceptability 
- 
Secondary outcome assessments of effectiveness and reach 

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3.2 Allocation to Treatment Groups 
Participants will be prospectively enrolled and randomized into one of two arms. Randomization will occur after enrollment 
on the Way to Health Platform utilizing random number generator. Specifically, permuted block randomization will be used 
for balance between cross-over arms throughout the investigation. The study coordinator will maintain the master list and 
securely store the randomization files. 
 
3.3 Study Duration, Enrollment and Number of Sites 
Recruitment and conduction of the trial is expected to start two years after notice of K23 award (3/1/2021) and be 
complete by four years after notice of award (4/1/2023). There are two  study sites, located at the Renal Clinics affiliated 
with the Renal, Electrolyte and Hypertension Division in the Perelman Center for Advanced Medicine and in Presbyterian 
Medical Center.  
 
3.3.1 Total Number of Subjects 
The study will be limited to 40 patients with CKD and hypertension. 
 
3.3.2 Duration of Study Participation 
The intervention will be conducted for each participant over a 12-week period. 
 
3.4 Study Population 
Patients with stage 3 or 4 CKD and hypertension seen in the Renal Clinic at PCAM and Presbyterian Medical Center 
scheduled for a follow up appointment.   
 
3.4.1 Inclusion criteria 
The criteria will aim to capture adult patients with hypertension (treated with three or less anti-hypertensive medications) 
and chronic kidney disease stage 3 or 4 managed in participating nephrology practices that will be aged 18 or over. 
Eligible patients will also be required to have an iPhone or Android smartphone that they state are willing to carry with 
them the majority of the time while enrolled in the study, able to comprehend English, , and have the ability to walk. 
Further inclusion criteria include a mean blood pressure reading of <=180/100 mmHg from historical blood pressure 
readings in the electronic medical record, and able and willing to provide informed consent 
 
3.4.2 Exclusion criteria 
Exclusion criteria included conditions that made participation infeasibility (inability to provide consent or read or speak 
English); having had MI or stroke within the previous six months, inability to self-monitor (e.g., diagnosis of dementia), 
inability to walk, already participating in another physical activity study,  or stated for any other reason that they did not 
expect to be able to complete the study. Other exclusion criteria include: vulnerable populations, likely to receive a kidney 
transplant within 1 month of enrollment into the trial, living in a long-term care or rehabilitation institution, likely to have 
their care transferred to another facility outside participating clinic areas during the course of the study, planning to travel 
or live consecutively out of the country for more than one month, participating in another intervention trial, cognitive 
impairment, mean blood pressure reading of >180/100 mmHg (stage 3 hypertension or greater requiring more urgent 
intervention than would be available in the study), hypertension not managed by the nephrologist in the clinic, prescribed 
more than three anti-hypertensive medications (i.e. resistant hypertension), an acute cardiovascular event in last 3 
months (as blood pressure and antihypertensive medication may not be stable), and any other reason they do not expect 
to be able to complete the study. 
 
4. Study Procedures 
4.1 Screening and Enrollment Visit 
At screening and enrollment (to be conducted remotely using the Way2Health platform), eligibility will be ensured and 
informed consent will be taken. Upon completion of the informed consent and screening survey questions (Appendix III), 
the Way2Halth platform will automatically create a unique study ID. Individuals not wanting to take part in the study will be 
provided with a form to return should they wish to decline to take part in the trial. This will ask for basic demographic 
information and their reasons for declining, including an option to give a reason if they prefer not to.  At study entry all 
participants will be given a brief training via the PSOM-secure Zoom video-based platform on how to use the Way to 
Health application after downloading onto their smartphone. Participants will be provided with details regarding how to 

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contact the research team via email or phone at any time if they subsequently wish to withdraw from the study. This 
contact information will remain easily accessible via the participants’ individual Way to Health web portal dashboards 
throughout the study. 
 
Participants will mailed an OMRON 5 series wireless blood pressure cuff (BP7250) or if preferred by the participant, given 
the OMRON blood pressure machine at one of the nephrology practices using appropriate social distancing and face 
coverings. The blood pressure monitor given to each participant will be checked for accuracy. Participants will be directed 
to a brief training video on how to correctly measure their blood pressure using this device. Participants will also be mailed 
a physical activity sensor watch (Fitbit Inspire 2) that will monitor their step counts, or if preferred by the participant, they 
will be given the FitBit at one of the nephrology practices using appropriate social distancing and with face coverings. The 
participants will be asked to wear the Fitbit every day for the entire 12 weeks. All participants will be asked to authorize 
the electronic transmission of de-identified data to the study database from the devices during the Way2Health enrollment 
phase.  
 
Instructions on how to correctly set up both wireless devices will also be mailed and available online as a google doc (see 
Appendix II).  
 
Participants will be asked to complete baseline questionnaires and report on their sociodemographic characteristics, 
including age, gender, highest level of education, and race/ethnicity, baseline step counts on their smartphone or on a 
computer. They will also be asked to fill out an action plan for their BP and daily step count goals. The intervention will 
commence after these baseline measures have been collected.  
 
At the end of the study, qualitative interviews will be scheduled with willing participants to provide an in-depth 
understanding of the factors that may facilitate or diminish the acceptability of the intervention and adherence to the 
implementation. Open-ended inductive questions will be used to elicit user perspectives and experiences of the 
intervention, allowing participants to freely describe their experiences and views in their own way. Interviews will be audio-
recorded, fully transcribed and analyzed thematically.  
 
4.4. Subject Completion/Withdrawal 
Participants will be withdrawn from the study if they become no longer eligible to participate (e.g., no longer can walk or 
self-monitor BP). Participants who choose not to continue with the study will be offered the opportunity to continue self-
monitoring only rather than withdrawing completely from the study and asked if they would be willing to be interviewed for 
additional feedback.  
 
5. Study Evaluation and Measurements 
 
5.1 Screening and monitoring Evaluations and Measurements 
A screening mean blood pressure measurement of ≤180/100 mmHg using historical blood pressures documented in the 
electronic medical record is required for enrollment. Additional measurements include the remote transmission of BP 
monitoring and daily step counts. Questionnaires listed below will collect patient reported measures.  
 
5.2 Efficacy Evaluations 
The efficacy measures in this trial are only secondary or exploratory as the study’s purpose is to assess feasibility. The 
study was not powered to detect efficacy or effectiveness. The evaluations of effectiveness will include questionnaire 
scores, BP measures and step counts at baseline, 4, 8 and 12 weeks. Questionnaires will be administered at baseline, 4 
weeks, 8 weeks, and end of the study (after 12 weeks). 
 
5.3 Feasibility Evaluations 
To assess feasibility, we will collect information on participant retention rates, usage of the SMART-HABITS application, 
transmitted blood pressure and step count data, usability surveys, and conduct semi-structured interviews to assess user-
experience.  
 
6. Statistical Considerations 
Since this is a feasibility study, there are no true primary endpoints for statistical consideration. 
  

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6.1 Primary Endpoints 
The RE-AIM framework, which focuses on five dimensions (reach, effectiveness, adoption, implementation and 
maintenance), considered to be important for behavioral health interventions will guide the evaluation for the primary 
endpoints of feasibility of the SMART-HABITS program. 
- 
1) Adoption: a) participant retention rate at 4, 8, and 12 weeks, b) Percentage of participants who used SMART-
HABITS at any point during the 12 weeks. 
- 
2) Adherence: a) percentage of self-monitored BP transmissions performed out of the recommended and b) 
percentage of step count data transmissions out of the recommended. 
- 
3) Acceptability: a) improvement of the pre- and post-study scores on the attitudes toward mHealth questionnaire, 
b) satisfactory ratings on the ease of use survey during the study and at the end of the study and, c) interview 
feedback after the end of the pilot study. 
 
6.2 Secondary Endpoints 
The secondary measures of effectiveness will include: a) change in pre-pilot and post-pilot questionnaire scores regarding 
CKD knowledge, self-efficacy, self-management, eHealth literacy and disease-related quality of life; b) change in baseline 
BP (as determined by the first BP measure transmitted) compared to mean BP after 4, 8, and 12 weeks, and c) change in 
mean step count in first week compared to mean step count after 4, 8, and 12 weeks. 
 
An additional endpoint includes an assessment of “Reach”, which will be the number and characteristics of participants 
enrolled in the study.  
 
6.3 Statistical Methods 
We will describe the study population with mean values (standard deviations) or medians and quartiles as appropriate for 
continuous variables and percentages for categorical variables using STATA software. Specifically, we will report the 
enrollment rate, the retention rate, and participant ratings on ease of use surveys. We will explore if these characteristics 
differ by age, gender, and education level with analysis of variance and Pearson’s Chi2-testing. We will report the 
adoption as the percentage of participant still enrolled in the intervention at 4, 8, and 12 weeks and the percentage of 
participants who used SMART-HABITS at any point during the 12 weeks of the pilot trial. We will report the percentage of 
the self-monitored BP transmissions performed out of the recommended and also the percentage of the step count data 
transmissions out the recommended during the pilot trial. 
 
We will perform an exploratory analysis of the change in 1) pre- and post-trial questionnaire scores, and 2) baseline BP 
and first week mean step count compared to the mean BP and step counts after 4, 8, and 12 weeks using paired t-tests, 
recognizing that over time the amount of information will diminish as we anticipate fall out, but also, a longer time for the 
intervention to have an effect. We will explore the association of baseline questionnaire scores with adoption and 
adherence with linear regression models adjusted for age, sex, race, and education. These will be exploratory analyses 
since the study was not powered to detect a statistically significant difference. We hypothesize that higher adherence and 
adoption will be associated with increased scores on baseline measures of self-efficacy, attitude toward mHealth, and 
self-management. We will also explore for trends in adherence with generalized linear mixed effects models and if blood 
pressure control or amount of steps modifies trend in adherence. 
 
6.4 Sample Size and Power 
The primary purpose of the pilot trial is to assess for acceptance and feasibility of a patient-centered mHealth self-
management support intervention. Therefore, no sample size was formally computed. 
 
7. Study Intervention 
7.1 Description 
The intervention will utilize the Way to Health platform to provide: a) text message reminders, b) text message tailored 
feedback in response to transmitted data on blood pressure (in the text message arm) and daily step counts, c) positive 
affirmation text messages sent throughout the study to encourage behavior participation, d) provide links to educational 
resources, including a video on demonstrating how to correctly perform blood pressure self-mentoring in the portal, e) 
provide links to community resources and CKD patient forums within the portal, and the f) option to select a accountability 
partner to share the participant's reminders and feedback. The intervention was developed using a theory-based, and 
evidence-based approach.  
 

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The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial 
randomization and enrollment processes, messaging (text, e-mail, voice), self-administered surveys, and secure data 
capture for research purposes.141,142 Way to Health has been used in prior behavior intervention studies.143-146  
 
At enrollment, a questionnaire (see Appendix IV) will be completed by all participants to capture demographics, kidney 
disease knowledge, ability to manage kidney disease, confidence in managing kidney disease, opinions of and ability to 
use mobile health technology. At enrollment, participants will complete a patient-generated “action plan” (questions in 
Appendix IV) in order to set realistic goals and encourage participants to create goals that involve positive action- with the 
minimum targets. Participants will develop short-term goals to help initiate changes and achieve success.  
 
 
Participants will be asked to check their BP at least three times per week and then to communicate these BP 
readings with the research team using text message or with the OMRON Connect app (depending on the phase- 
please see below), and upon receipt, the participants will then receive tailored feedback. 
 
Participants will be asked to set a daily step goal of at least 3,000 steps per day at the start of the study and 
transmit their step count information to the research team on a daily basis. By providing a minimum threshold puts 
more emphasis on encouraging more sedentary individuals to walk more and less emphasis on getting highly 
active individuals to be more active. Participants will be reminded once a day in the evening to sync their steps 
with the FitBit app in order to transmit them to the Way to Health platform. Participants will receive daily individual 
performance feedback on their steps from the previous day. Participants will later be sent messages to see if they 
would like to increase their daily step goal. 
 
 
Participants will be instructed how to correctly undertake BP self-monitoring to promote self-efficacy through a 
demonstration video available on Way to Health. Participants will be asked to rehearse self-monitoring at the initial study 
visit via a secure video-based platform using Zoom.  
o 
Phase 1 (weeks 1-6): 
o 
After consenting to participate in the study, participants will be randomized to start with Texting (Arm 1) or 
the OMRON Connect App (Arm 2) to communicate BP readings. 
o 
Each arm will receive specific instructions pertinent to the specific phase tasks - available as a google 
document and will also be mailed at the beginning of the study (Appendix II).  
o 
Participants randomized to the texting arm in Phase 1 will receive automated text message reminders to 
check their BP on a personalized basis (minimum of three days per which) as participants will choose 
which days and times to receive these reminders at the beginning of the study. Participants will then 
transmit the BP readings with text message to the secure Way to Health server.  If a blood pressure 
reading is not received within 3 hours, another reminder will be sent. Automated text message feedback 
will be sent after the BP reading is recorded with a tailored message regarding any further required 
actions based upon the BP readings obtained. Any participant with a single systolic blood pressure 
reading >200mmHg or two consecutive systolic blood pressure readings >180 mmHg or diastolic blood 
pressure readings >110 mmHg will be contacted immediately by an MD (Dr. Schrauben) for assessment 
(including evaluation for symptoms of hypertensive emergency) and referral to the emergency 
department, if indicated. Please see full text message algorithm (Appendix VII).  
o 
Participants randomized in Phase 1 to the OMRON Connect App arm will complete the same survey 
questions as those in the Texting Arm. Participants using the OMRON connect app will also receive 
reminder messages on a similar frequency as the texting arm and will also be customized the partiicpant’s 
schedule as they can choose which days and times to receive push notification reminders delivered by 
the OMRON connect app. Upon receipt of the BP reading, participants will receive similar BP feedback 
(Appendix VII). 
o 
Phase 2 (weeks 7-12): 
o 
At the conclusion of week 6, individuals will “crossover” to the opposite study arm and will continue in the 
study for an additional 6 weeks using the opposite technology to communicate their BP readings.  
 
 
Motivating and positive affirmation messages will be sent to participants on a weekly basis (Appendix VII). After 4 weeks, 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
12 
and 8 weeks of the intervention, a usability survey (Appendix V) will be sent out to assess the ease of use of SMART-
HABITS.  Automated messages will be sent at key milestones to promote adherence to study procedures. Weekly 
feedback will be sent the morning after the end of the week. Daily feedback on performance from the prior day will be sent 
each morning.  
 
 
Within SMART-HABITS’ smartphone web-based application, there will be a portal which provides: 
- 
Educational information that incorporates both clinical and lay-experiential CKD knowledge: Educational 
resources will present the health-related benefits of self-monitoring, reducing blood pressure, and increasing 
physical activity. Positive expectations will be outlined by ways that use self-monitoring BP and increasing 
physical activity may reduce the chances of experiencing negative health consequences.  
- 
Graphical displays of personally set goals and real-time progress to goals 
- 
Web links to social support  
 
Throughout the study, if participants are identified to have low engagement with the intervention, identified through remote 
monitoring and defined as no BP readings for >1 week or no step counts in 4 days, they will undergo a re-engagement 
protocol. The re-engagement protocol includes the research team contacting participants with text messages to re-engage 
them and if after two attempts, the participant continues to not be engaged, they will be called and interviewed over the 
phone to provide more granular information to assess real-time barriers.  
 
8. Safety Management 
There will only be direct contact with human subjects if they are given the wearable devices in person but this would only 
be done so in a socially distanced fashion (at least 6 feet apart) and with appropriate face coverings. There will be an 
intervention delivered by health information technology to help encourage healthy behaviors. The potential risk posed by 
study participation remains minimal, as the intervention is simply text reminders and collection of data from self-monitoring 
of blood pressure and physical activity via remote devices. According to the Food and Drug Administration (FDA) 
guidance, the Way to Health research platform, Fitbit and OMRON blood pressure machine wearable devices would be 
considered general wellness products since they meet the following two factors: (1) intended use that relates to 
maintaining or encouraging a general safety of health or a healthy activity or an intended use that relates the role of 
healthy lifestyle with helping to reduce the risk or impact of certain chronic disease or conditions (e.g, weight 
management, blood pressure management, physical fitness, self-esteem), and (2) present a low risk to the safety of users 
and other persons since the mHealth technology and wearable device are not invasive, are not implants, and do not 
involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory 
controls are applied (e.g., lasers or radiation exposure). General wellness products may include software programs and 
other products that are commonly, though not exclusively, available from retail establishments. A mobile application or 
wearable device that solely monitors and records physical activity or blood pressure might present a risk of inaccuracy, 
but the technology does not pose a risk to the safety of users and others persons if specific regulatory controls are not 
applied. Additionally, a mobile technology that reminds users of measures to reduce a medical condition or increase 
health does not pose a risk to the safety of users and others persons if specific regulatory controls are applied. Since we 
have access to participants smartphones, there is potential loss of confidentiality. Additionally, the risks posed by blood 
pressure monitoring, and participating in general wellness, such as increasing physical activity poses no greater risk than 
if not participating in study or usual care. Additionally, the health behavior interventions delivered through Way to Health 
have been shown to be safe. 
 
Additionally, this study will include the following data and safety monitoring plan. 
 
Purpose: The data and safety-monitoring plan is written to ensure the safety of participants and verify the validity and 
integrity of the data. This monitoring plan details the source data verification of intervention, safety parameters, and the 
frequency of monitoring and regulatory document review. 
Risk of Study: The study incurs minimal risk because the Way to Health research platform has proven to be safe in 
multiple prior behavioral health intervention studies, the technology and devices used in the feasibility trial are considered 
by the FDA to be general wellness products, and the real risk is to confidentiality. 
 
Responsible Parties of Monitoring 
1. Principal investigator: The PI will regularly monitor the data in collaboration with the research team. 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
13 
The PI will also be responsible for ensuring all source documentation exists for the data and all corrections are done 
according to the principles of Good Clinical Practice. 
2. IRB: periodic review by the University of Pennsylvania’s IRB. 
3. Research Assistant (RA): during the course of the study, safety and data quality monitoring will be performed on an 
ongoing basis by the RA, in addition to the PI. The RA will be responsible for monitoring all data collected. 
Ongoing Monitoring Meeting: monitoring days will be conducted periodically throughout the study; beginning no later than 
2 weeks after the first participant is enrolled. Subsequent monitoring meetings will be every four weeks. 
Assessing Adverse Events: Monitoring for adverse events will be conducted by the PI, Dr. Schrauben, and the RA. 
Participants will be asked an open-ended question via Way to Health to assess if participants are experiencing any 
medical concerns related to their participation in the study. 
Reporting Events: Any side effects of notable medical concerns will be reported to the PI to determine a course of action. 
Any adverse effect will be reviewed by Dr. Schrauben and Dr. Feldman (primary mentor). After removal of identification 
information, all serious adverse events will be reported to the University of Pennsylvania IRB and the funding agency 
within 24 hours. All adverse events will be recorded and a summary table reviewed by the IRB annually. 
Data, Safety, and Monitoring Report: The PI will provide a summary of the DSM report on an annual basis as part of the 
progress report. The DSM report will include the expected versus actual recruitment rates, retention rates, any quality 
assurance and regulatory issues that occurring during the past year, summary of adverse events, and any actions or 
changes with respect to the protocol. Copies of each report and documentation of IRB notation and receipt will be kept in 
the PI’s study file. 
 
9. Study Administration 
 
9.1 Treatment Assignment Methods 
All participants in the study will be assigned to the interventions but in a different order (first 6 weeks or second 6 weeks of 
the study) since this is a cross-over design.  
 
9.2 Data Collection and Management 
Questionnaires will be completed electronically through the Way to Health Platform on the SMART-HABITS app on a 
participant’s smartphone or on a computer at enrollment (Appendix IV) and at the end of study (Appendix VI). 
Questionnaires include:  
1. Measure of CKD Knowledge: Kidney Knowledge Survey (KiKS)147 
2. Measure of e-health literacy: eHealth Literacy scale (eHEALS)- an eight-item measure of eHealth literacy 
developed to measure individuals’ combined knowledge and perceived skills at finding, evaluating, and 
applying electronic health information to health problems.148 
3. Measure of chronic disease self-efficacy: Self-efficacy for Managing Chronic Disease Scale (SEMCDS)- 6 
item scale.149 
4. Self-management in Chronic Disease: Partners in health scale150,151  
5. Kidney Disease Quality of Life (KDQOL-36)152, consists of five subscales:  
o 
1- Physical component summary (12 items about general health, activity limits, ability to 
accomplish desired tasks) 
o 
2 -Mental component summary (12 items depression and anxiety, energy level, and social 
activities) 
o 
3- Burden of kidney disease (4 items on how much kidney disease interferes with daily life, takes 
up time, causes frustration, or makes the respondent feel like a burden) 
o 
4- Symptoms and problems (12 items about how much respondent bothered by CKD related 
symptoms) 
o 
5- Effects of Kidney Disease on Daily life (7 items about much how respondent bothered by fluid 
limits, diet restrictions, ability to work around the house or travel, feeling dependent on doctors or 
other medical staff, stress or worries, sex life and personal appearance).  
Several questions from the Attitudes toward mHealth and remote monitoring (10 item questionnaire).69  
 
Data collected from participants’ smartphone using Fitbit app and OMRON Connect ap, including survey and 
questionnaire responses and will be sent electronically to the Way to Health research platform and stored on a secure 
data server. This system is hosted onsite at the University of Pennsylvania with a level of security identical to that used for 
the clinical data of patients within the University of Pennsylvania Health System. 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
14 
 
We will use Federal Information Processing Standards (FIPS) to assure secure, HIPAA-compliant data control and 
management to minimize risks by using rigorous data security protocols to protect subject confidentiality and comply with 
all federal and HIPAA requirements. Databases will be password protected, further restricting access to only study 
personnel. Interview transcript data will be labeled with a unique ID number, which will be linked in a separate password 
protected file, to demographic data.  Study information will not be included in any medical records.  
 
All study computers will sit behind the University's firewall protection and in locked offices. Further, our computers are 
continually scanned for vulnerability and to insure that no personal identifying information is found in appropriate places. 
All analyses will be conducted on de-identified data on secure computers. Lastly, using network firewall technologies, the 
database administrator will prevent the three major sources of data security problems: unauthorized internal access to 
data, external access to data, and malicious intent to destroy data and systems. Controlled user access will ensure that 
only appropriate and authorized personnel are able to view, access, and modify study data. 
 
9.3 Confidentiality and Privacy 
The risk of loss of confidentiality is paramount since we will have access to the participant's phone number but extensive 
efforts will be made to ensure that participants’ confidentiality is maintained. To assure that participant confidentiality is 
preserved, individual identifiers (such as name) are stored in a single password protected system that is accessible only 
to research staff. Each participant will be assigned a unique study identification number and will never be tracked through 
the study by name, social security number, medical record number, and no other patient identifier other than mobile 
phone number. The study ID number will be used on all data collection instruments. A log of participant names, participant 
ID numbers, and pertinent registration information (e.g. emergency contact information) will be maintained in a locked 
area. Only de-identified data will be stored securely on servers.  
All study staff will be reminded to appreciate the confidential nature of the data collected and contained in these 
databases. The Penn Medicine Academic Computing Services (PMACS) will be the hub for the hardware and database 
infrastructure that will support the project and is where the Way to Health web portal is based. The PMACS is a joint effort 
of the University of Pennsylvania's Abramson Cancer Center, the Cardiovascular Institute, the Department of Pathology, 
and the Leonard Davis Institute. The PMACS provides a secure computing environment for a large volume of highly 
sensitive data, including clinical, genetic, socioeconomic, and financial information. Among the IT projects currently 
managed by PMACS are: (1) the capture and organization of complex, longitudinal clinical data via web and clinical 
applications portals from cancer patients enrolled in clinical trials; (2) the integration of genetic array databases and 
clinical data obtained from patients with cardiovascular disease; (3) computational biology and cytometry database 
management and analyses; (4) economic and health policy research using Medicare claims from over 40 million Medicare 
beneficiaries. PMACS requires all users of data or applications on PMACS servers to complete a PMACS-hosted 
cybersecurity awareness course annually, which stresses federal data security policies under data use agreements with 
the university. The curriculum includes Health Insurance Portability and Accountability Act (HIPAA) training and covers 
secure data transfer, passwords, computer security habits and knowledge of what constitutes misuse or inappropriate use 
of the server. We will implement multiple, redundant protective measures to guarantee the privacy and security of the 
participant data. All investigators and research staff with direct access to the identifiable data will be required to undergo 
annual responsible conduct of research, cybersecurity, and HIPAA certification in accordance with University of 
Pennsylvania regulations. All data for this project will be stored on the secure/firewalled servers of the PMACS Data 
Center, in data files that will be protected by multiple password layers. These data servers are maintained in a guarded 
facility behind several locked doors, with very limited physical access rights. They are also cyber-protected by extensive 
firewalls and multiple layers of communication encryption. Electronic access rights are carefully controlled by University of 
Pennsylvania system managers. We believe this multi-layer system of data security, identical to the system protecting the 
University of Pennsylvania Health Systems medical records, greatly minimizes the risk of loss of privacy. In addition, risk 
of loss of confidentiality will be minimized by storing signed informed consent forms in locked file cabinets in locked offices 
accessible only to trained study staff. Each subject will be assigned a unique identifier without identifying information, and 
data will be entered into an electronic database using only the unique identifier. Only trained study staff will have access 
to the code that links the unique identifier to the subject’s identity. Electronic data will be stored on secure, password-
protected firewalled servers at the University of Pennsylvania. 
 
The study team will work to uphold the privacy of the participants in several ways. First, any communications made 
among study staff regarding participants will use ID numbers only and never include names or other personal information. 
Second, all paper copies of participant data will be kept in locked files. Third, in all data sets, we will use ID numbers only.  

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
15 
A separate list of linking names with ID numbers will be accessible by the research team that is kept separate from data 
collected for the pilot study in a password-protected file on a password protected computer in a locked office.  
Whether in person or by phone, the research team will ensure that no persons who are not authorized by study 
participants to share personal health information are in the room when discussing informed consent (Appendix I) or during 
data collection at the initial study visit or at the end of study interviews.  
 
Dr. Schrauben and a research assistant will conduct the end-of-study interviews and will have formal training by the Mixed 
Methods Research Laboratory at the University of Pennsylvania. The training will include proper methods for handling 
sensitive issues that arise during the interviews (note that the interviews themselves are not intended to include sensitive 
issues but because of their open-ended nature this possibility must be considered). Data from the interviews will be 
transcribed using a HIPAA-compliant service and verbatim transcriptions will be provided to the study team void of any 
personal identifiers and thus, only anonymous data will be used for all analyses. 
 
 
9.4 Regularity and Ethical Considerations 
Dr. Schrauben will be responsible for carrying out registering the clinical trial and submitting summary results to 
ClinicalTrials.gov for public posting. Dr. Schrauben will also be responsible for registering the trial in ClinicalTrials.gov no 
later than 21 calendar days after the enrollment of the first participant and submitting results information no later than one 
year after the trial’s completion date. In addition, informed consent documents will include a specific statement relating to 
posting of clinical trial information at ClinicalTrials.gov. 
 
There are no ethical considerations of the recruitment or intervention that are anticipated at this time. 
 
9.5 Recruitment Strategy 
We will recruit adult patients with chronic kidney disease stages 3 or 4 that also have diagnosed hypertension for the pilot 
study from Renal Clinics within the Department of Medicine at the Perelman School of Medicine for both genders and all 
races and ethnicities. We are targeting CKD stage 3 and 4 and hypertension since we believe that at these stages, a 
behavioral intervention could have a greater influence on the trajectory of blood pressure control and CKD complications. 
Additionally, patients with later stages of CKD reported they wished they had understood the importance of self-
management earlier.  
 
As a faculty member of the Division of Renal-Electrolyte and Hypertension within the Department of Medicine, the PI (Dr. 
Schrauben) will have access to patients that are seen in the Division-affiliated clinics located within the Perelman Center 
for Advanced Medicine (PCAM) and at Penn Presbyterian Medical Center. We will aim to recruit up to 40 patients with 
stage 3 or 4 CKD and hypertension over an 18-24 month period, which conservatively is 1-2 recruited patients per month. 
Since there are approximately 88 patients with stage 3 CKD and concomitant hypertension seen monthly in the Renal 
Clinic at PCAM, we do not anticipate difficulty enrolling participants during the study period since our conservative 
recruitment rate translates to approximately 2% per month.  
 
If recruitment is slower than expected, recruitment will be expanded to include an additional Division-affiliated Renal 
clinics (located at Radnor), and if it continues to lag, we will expand eligibility criteria to stage 2 and 5 CKD. In the event of 
lost to follow up, we will be able to contact participants via text message, and implement a re-engagement protocol, but if 
we observe 20% loss to follow up, we will enroll more patients. 
 
Recruitment will focus on patients scheduled for follow-up appointments in two nephrology clinics associated with the 
Renal Division within the Department of Medicine at the Perelman School of Medicine. Patients identified from review of 
the list of scheduled follow up appointments in the Renal Clinics who also have the diagnoses of CKD stage 3 or 4 and 
hypertension will be identified for potential eligibility for the study. After reviewing the schedule of follow up appointments 
in the renal clinic, the research team (i.e., Dr. Schrauben or a research assistant (TBD)) will first contact the nephrologist 
of the scheduled patient for potential eligibility. Then, a letter of invitation will be sent by the research team followed by a 
phone call. During the recruitment phone call, research personnel will review the inclusion and exclusion criteria, introduce 
the study rationale and procedures and try to answer any questions. In addition, there will be study advertisements posted 
within the clinic (for when in-person visits occur more regularly). With those who respond to the invitation or inquire about 
the posters, the interested individuals will be directed by the research team to the Way2Health enrollment site for further 
screening for eligibility using a screening survey. If the interested individuals have any remaining concerns or questions, 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
16 
they will be asked to contact the research team for further discussion. During the online enrollment process, informed 
consent will also be obtained. 
 
Patients eligible for the study will have blood pressure readings of less than SBP 180 mmHg and diastolic 110 mmHg in 
the previous 12 months. We will attempt to avoid commencing the intervention during time periods of extreme outdoor 
temperatures to prevent seasonal effects of physical activity participation.  
 
At the conclusion of the pilot study, we will perform purposive sampling of the study participants to ensure there is 
representation of participants with high and low engagement in the mHealth intervention to ensure maximum variation to 
assess user experience (n=5-10). 
 
Any subject facing materials, including by not limited to, recruitment letters, flyers, and text message templates, will be 
provided for IRB review prior to use. 
 
8.6 Informed Consent 
All research personnel associated with the study will have completed the CITI-Protection of Human Subjects Research 
Training as well as HIPAA Compliance Training.   
 
The process of informed consent will be carried out using the Way 2 Health online platform. During this process, 
individuals who have been deemed eligible will be informed of all aspects of the study so they can make an informed 
decision. Participants will then confirm their willingness to participate in the research study by electronically signing the 
informed consent form. Informed consent will be collected along with a HIPAA authorization form that will provide consent 
for study participation, which will entail downloading the Way to Health application onto each participants' individual 
smartphone, device authorization for the OMRON Connect app, OMRON blood pressure monitor, Fitbit and Fitbit app, 
along with agreeing to monitor BP and wear Fitbit for the entirety of the study, text message BP readings during the text-
message phase, syncing the wearable devices with apps during the appropriate study periods, receiving intermittent text 
messages from the study team, and completing questionnaires at the beginning, at 4-weeks, at 8-weeks and at the end of 
the study period. Patients will be informed of the potential risk of loss of confidentiality and the measures in place to 
protect against it. The application and devices will not record any personal or sensitivity information or require access to 
other information in the participant’s phone (e.g., contacts, location, etc.). 
 
All subjects will provide informed consent to participate in our study, including: access to their smartphone through Way to 
Health technology, access to wearable devices, transmission of data from remote sensors to the study database, sending 
surveys and messages to their phones, for a semi-structured interviews to be conducted at a later point in the study, and 
potentially including an individual to share reminder and progress messages. Participants will be told that they do not have 
to answer any questions if they do not wish and can drop out of the study at any time without affecting their medical care 
or the cost of their care. They will be told that they may or may not benefit directly from the study and that all information 
will be kept strictly confidential, except as required by law. Please see Appendix I for informed consent. 
 
 
9.7 Payment to Subjects 
Participants will be given a $25 gift card for compensation of their participation at two separate time points (at 6 weeks 
and at conclusion of study). For participants that agree to and participant in an end-of-study interview, they will also 
receive another $25 gift card. The participants will not be required to return the blood pressure cuff or the activity monitor 
and are encouraged to keep them for use after the study completion.  
 
9. Publication 
 
We anticipate that the results generated by this study will result in publications in peer-reviewed journals and these 
published results will include detailed methods to describe subject selection should other investigators wish to use the 
data generated for future research related to self-management in chronic kidney disease. In conducting this study, we will 
develop a unique dataset derived from the data collected through interviews and the feasibility trial. In the future, if 
valuable additional analyses of the data are proposed, we will take every effort to ensure that analyses are completed 
efficiently and to the highest standards. We will only share de-identified data for research purposes, and will require 1) 
Institutional Review Board approval, 2) appropriate measures to ensure security of the data, and 3) commitment to 

Study Protocol: Supporting Self-Management of Healthy Behaviors (SMART-HABITS) 
 
 
 
 
17 
destroying or returning the data after the analyses are completed. 
 
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