Development of a Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy (Moms@Home)
Phase: NA
Conditions: Hypertension in Pregnancy, Chronic Hypertension, Gestational Hypertension
Sponsor: University of Massachusetts, Worcester

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 1 of 18 
Template 
Revised 03/15/2021 
 
Official Study Title: Development of a Mobile Health Intervention to Improve Blood Pressure 
Management in Pregnancy (Moms@Home) 
 
NCT Number : K23HL163450 
 
Date of Document : November 7th 2024 
 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 2 of 18 
Template 
Revised 03/15/2021 
1. TITLE 
Development of a Mobile Health Intervention to Improve Blood Pressure Management in 
Pregnancy (Moms@Home) 
 
2. EXTERNAL IRB REVIEW HISTORY 
NA 
 
3. PRIOR APPROVALS: 
NA 
 
4. OBJECTIVES 
Aim 1: Conduct a pilot randomized controlled trial (RCT) of Moms@Home vs. enhanced 
standard care (ESC). We will enroll 100 pregnant women (50% from racial/ethnic minority 
groups) with gestational or chronic HTN to determine whether Moms@Home vs. enhanced 
standard care (BP monitor, diary) improves HBPM adherence (primary outcome). We will also 
determine the feasibility, acceptability, and sustainability of the 8-week intervention. Hypothesis 
1: Participants in the intervention MOMS@HOME group will have better adherence to HBPM, 
compared to participants in the control ESC group at 8 weeks.  
 
5. BACKGROUND 
Description of the Problem : Hypertension in pregnancy is highly prevalent, its frequency is 
increasing in the United States, and accounts for 40% of maternal mortalities in the US. The time 
required for frequent in-person visits, inadequate counseling, and the asymptomatic nature of 
hypertension are major barriers to effective blood pressure (BP) control in pregnant women. 
These issues can be addressed through the use of home BP monitoring (HBPM), which reduces 
the risk of preventable and devastating clinical events and reduces racial inequities in people who 
are pregnant. Obstetric societies recommend HBPM for all people who are pregnant with 
hypertension, but many studies suggest that the rates of counseling for HBPM and uptake are 
low.  
 
Significance : Barriers to blood pressure (BP) control in people who are pregnant can be 
addressed by home BP monitoring (HBPM), which has multiple advantages over clinic-based BP 
but is underutilized in people who are pregnant. Improving BP control and reducing health 
inequities are top national priorities, as the adverse effects of hypertensive disorders in 
pregnancy are lifelong and convey a 2–8-fold increased risk of cardiovascular disease.1–3 
Although people wo are pregnant are motivated to self-manage BP, barriers to BP control based 
on clinic-based BP measures include the challenges with mothers having time off from work and 
costs for frequent visits, lack of information about self-care, and low engagement with in-person 
clinic visits.4-9 Clinic-based BP is a poor surrogate for average daily BP, and HBPM values are 
superior with regard to reliability and prognostic value for mortality and adverse pregnancy 
events.10–13 By facilitating more timely HTN diagnosis and BP control, HBPM reduces the risk 
of preventable and devastating clinical events.14–17 Adults using HBPM are more likely to take 
BP medications and have diagnosed, treated, and controlled HTN.18–20  
Digital health interventions can overcome barriers to HTN management but need to be tested in 
people who are pregnantwith HTN. CareEvolution’s MyDataHelpsTM (MDH) mobile health 
application (app) was designed to promote HBPM and facilitate communication between people 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 3 of 18 
Template 
Revised 03/15/2021 
and their care teams. Designed by diverse Patient Advisory Groups, MDH’s secure health 
dashboard displays BP data and sends text notification reminders to perform HBPM. The MDH 
app has been used to support multiple NIH-funded cohorts including the electronic Framingham 
Heart Study (eFHS), RURAL, MIPACT, and DETECT.21  In the eFHS, women were more likely 
than men to enroll in HBPM, with 62% regularly using HBPM through 1 year.21,22 In pregnant 
women, digital health interventions improve patient engagement and health equity while 
allowing for early detection of pregnancy-related problems and communication with care 
teams.17,23 Digital health also reduces wait times and access barriers based on geography or 
mobility.24-28 Increasing smartphone adoption and validated Bluetooth BP monitors, with ability 
to transmit data remotely, have made HBPM more accessible.29-31  
The most effective self-management interventions, including digital health interventions in 
pregnancy, are grounded in Social Cognitive Theory and incorporate four primary constructs: 
training/modeling, self-monitoring, goal setting, and reinforcement.32,33 Moms@Home will 
integrate these constructs to increase self-efficacy and improve BP control.34,35  
Storytelling is an evidence-based approach with universal appeal to support behavior change and 
BP control, especially in racial/ethnic minority groups. Storytelling is based on a rich oral 
tradition common in Black and Hispanic cultures and appeals to the human affinity for sharing 
stories.36,37 This approach is especially effective at reaching persons of racial/ethnic minority 
groups if the stories are grounded in shared experiences.38,39 Storytelling’s effectiveness in 
changing behavior relates to breaking down cognitive resistance through transportation 
(absorption in the story) and “homophily” (similarities between the storytellers and participants) 
to change attitudes, skills, and behaviors37,40. Integration with technology and the care team can 
sustain behavior change, but input from patients and providers is critical. 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
Participant inclusion/exclusion: 
Inclusion criteria: 
(1) Age 18-50 
(2) Singleton or multiple pregnancies 
(3) English or Spanish speaking 
(4) Diagnosis of Chronic hypertension (8-26 weeks gestational age) or gestational 
hypertension (20-26 weeks gestational age) 
(5) A patient of the UMass Memorial Health OB/MFM clinics in Worcester, MA 
(6) Willing to share HBPM data 
(7) Comfortable with the use of smartphones and mobile apps 
Exclusion criteria: 
(1) Severe HTN (BP greater than or equal to 160/110mmHg at the enrollment visit) 
(2) Current diagnosis of preeclampsia 
(3) Active substance use 
(4) Serious physical illness or any illness that makes them unable to interact with a smart 
device 
(5) Enrolled in another HBPM program 
(6) Excluded from study participation by their provider 
(7) Inability to provide informed consent 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 4 of 18 
Template 
Revised 03/15/2021 
(8) Prisoners  
OB/MFM Provider Inclusion/Exclusion (N=10):  
Inclusion criteria: OB/MFM providers (attending physicians, residents, advanced 
practitioners, nurses) involved in caring for RCT participants. 
Exclusion criteria: Inability to verbally communicate in English.  
 
7. STUDY-WIDE NUMBER OF SUBJECTS 
NA 
 
8. STUDY-WIDE RECRUITMENT METHODS 
NA – this is not a multi-site study. 
 
9. STUDY TIMELINES 
Duration of an individual subject’s participation in the study: 8 weeks  
Duration of the post-study focus groups is estimated to be 1-1.5 hours 
Duration anticipated to enroll all study subjects: 1.5 years, longer if not meeting recruitment 
goals. 
Estimated timeline for investigators to complete this study: 2 years  
 
10. STUDY ENDPOINTS 
Aim 1: 
Primary outcome measures: 
- 
Home Blood Pressure Monitoring (HBPM) adherence at 8 weeks 
- 
Feasibility of Moms@Home– assessed through post-intervention focus groups 
(intervention group only) 
- 
Acceptability of Moms@Home – assessed through the End-user Mobile Application 
Rating Scale survey administered at 8 weeks, and the post-intervention focus groups 
(intervention group only) 
Secondary outcome measures: 
- 
Engagement with the Moms@Home mobile app will be measured by number of logins, 
time spent in the app, and storytelling videos watched (4, 8 weeks) 
- 
BP measures - HBPM measures will be gathered from the Moms@Home app and paper 
BP diaries. Electronic health record review will be used to determine clinic BP values 
- 
Medication adherence – change in medication adherence will be assessed through a brief 
survey (baseline, 4, 8 weeks) 
- 
Goal attainment scaling - goal attainment will be rated using a 5-point goal attainment 
scale (baseline, 8 weeks) 
- 
Physical activity - change in physical activity will be tracked by the FitBit (baseline, 4, 8 
weeks) 
- 
Moms@Home app sustainability measured with a short sustainability survey (4, 8 weeks) 
- 
Healthcare utilization measures (ex. # of clinic visits, ED visits, admissions) and clinical 
outcome measures (ex. gestational age at delivery, preeclampsia) (baseline, 4, 8 weeks 
- 
Self-efficacy measure using the self-efficacy for hypertension questionnaires (baseline, 4, 
8 weeks) 
 
Primary safety endpoints 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 5 of 18 
Template 
Revised 03/15/2021 
- 
N/A 
Secondary safety endpoints 
- 
N/A 
The primary outcome measures will be assessed using the Observed vs Expected number of 
HBPM readings recorded for participants over the study period. Group comparison will be done 
between the Moms@Home group vs ESC group. 
 
11. PROCEDURES INVOLVED 
Patients who are seen at the four UMass Memorial Health OB/MFM clinics in Worcester, MA 
will be recruited for the study. Participants will be recruited with the use of culturally sensitive 
recruitment materials and outreach plans vetted by the study’s Patient Advisory Group (approved 
through STUDY00000395). Participants will be identified using a list generated by the Research 
Informatics core, through direct referrals from OB/MFM providers and community-based 
organizations via flyers, emails, and social media messages. Flyers (electronic and print) will be 
shared with community partners (e.g., Together For Kids Coalition, Worcester YMCA) via email 
or via hard copies. Community partnering organizations and individuals in the patient advisory 
group may post these flyers on their websites and social media platforms. Invitation letters will 
also be sent through MyChart (patient portal) and to home addresses 5–7 days before clinic visits 
with an opt-out link and phone number. Follow-up calls will be made to assess interest from 
people who do not respond to the invitations within 1-2 days before clinic visits. We aim to 
enroll 50% Black, Hispanic, and Asian pregnant individuals, as these populations need to be 
overrepresented to mirror disease presentation and achieve equitable representation. 
 
Participants will be seen during their in-patient encounters or outpatient clinic visits to be 
consented if interested in the study and after providing more information about the study. After 
consenting, participants will then be randomized to Moms@Home arm or the ESC arm of the 
study using a permuted block randomization method stratified by clinic, in blocks of multiples of 
two. Those not providing consent will be asked a few questions to collect information on why 
they are declining participation. 
 
A contact list of people declining to participate will be stored in Redcap and destroyed 6 years 
after study completion. 
 
OB/MFM caregivers will be introduced to the Moms@Home approach and trained on the HBPM 
report (which will be delivered every 2 weeks during the study) at monthly OB/MFM department 
meetings and through job aids leading up to and during the start of the study. 
 
Study arms: 
Moms@Home intervention arm: Participants randomized to Moms@Home will receive the 
Moms@Home app (± Samsung smartphone), the digital BP monitor and cuff, and FitBit activity 
tracker. An orientation, FAQ sheet and HBPM pamphlets will include HBPM instructions, safety 
protocols, an introduction to the app, and tech support for the digital BP monitor, app, and FitBit. 
The FAQ sheet and HBPM pamphlet will be generated and submitted through a later 
modification of the IRB for approval before use. Participants randomized to the Moms@Home 
intervention arm will be helped by research staff to download and set up the MDH app and will 
be provided with a Bluetooth enabled blood pressure cuff and a FitBit that syncs with MDH . 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 6 of 18 
Template 
Revised 03/15/2021 
Participants in the Moms@Home arm who do not have a smartphone, or have a limited data plan 
and prefer a study phone will be provided with a study smartphone, which they will return after 
their time on the study. Participants will each select personalization for daily notifications and set 
one personal goal. Participants will also be reminded to take daily home blood pressure 
measurements to be synced into the app.  
 
Enhanced Standard Care (ESC) arm: Participants randomized to Enhanced Standard Care 
(ESC) will receive the digital BP monitor and cuff, a paper diary to record BP values, and a 
FitBit activity tracker. A modified orientation and FAQ sheet will include the same HBPM 
instructions, safety protocols, and tech support for the digital BP monitor and FitBit. Participants 
will each set one personal goal. Participants will also be reminded to take daily home blood 
pressure measurements to be recorded in the paper diary. 
 
At home, over the 8-week RCT, participants will be instructed to measure their BP daily (2 
readings, separated by 1 min) after a 3 min rest period. An HBPM video for reference will be 
part of the Moms@Home portal. The Moms@Home portal can be programmed with English or 
Spanish as default language and all videos will have Spanish subtitles. Traffic light (red, yellow, 
green) alerts and actions for abnormal BP values will be reviewed using a teach-back method. 
Participants will also be instructed to wear the study FitBit for daily activity and heart rate 
monitoring. Data from the FitBit will be transmitted through the MDH app to the study team for 
participants randomized to the intervention arm. For participants who are randomized to the 
enhanced standard care  arm, de-identified physical activity i.e. daily steps, heart rate data and 
sleep data will be collected via encrypted methods through the FitBit app. Staff will be able to 
confirm data transmission prior to the participant heading home. The research team will call 
participants 1–3 days after their scheduled start to address any concerns, ensure data capture, and 
provide tech support. 
 
Participant data will be collected at baseline (study entry) and the 8-wk follow-up in the privacy 
of the OB/MFM office (before or after clinic visits). Participants will be asked about their age, 
ethnicity/race, medication use, baseline HBPM use, and health literacy. If the 8-wk follow-up 
cannot be scheduled in person, this will be conducted over the phone or over Zoom. All 4-week 
follow-up visits will be done through a phone check-in. Study staff responsible for outcome 
assessment will be blinded to group assignments. Assessments will be pre-tested to ensure the 
time burden does not exceed 30 minutes. 
 
 
Post-intervention focus group: After completing the 8-wk pilot test, three participant focus 
groups (intervention arm only, N=5/group, 1–1.5-hours) will discuss their experience and 
barriers/facilitators to engagement with Moms@Home.  
 
Two focus groups with providers (N=5/group for a total of 10 providers, 1-hour) will focus on the 
home BP report experience, with one group of low utilizers and a second group of high utilizers of 
the electronic health record HBPM reports. Verbal consent for providers interested in focus group 
participation will be documented in Redcap. 
 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 7 of 18 
Template 
Revised 03/15/2021 
All focus groups will be held at UMass if in-person (in the ACC building 4th floor conference 
room or the Memorial campus Peter Levine or 4-West conference room) or on Zoom depending 
on the schedules/preferences of the participants. These groups will be co-led by Dr. Kovell and a 
research coordinator trained in qualitative interviews. Both participant and provider semi-
structured guides will be developed using the implementation measures of acceptability, 
appropriateness, and feasibility. The semi-structured guides will be submitted through a later 
modification of the IRB application for approval before the interviews are conducted. The focus 
group recordings will be uploaded to the password protected UMass Chan QMC network drive. 
Back-up copies of the video files will be stored in an external, password-protected hard drive and 
a Secure Digital (SD) card. Transcripts will be stored in the same hard drive and a password 
protected UMass Chan QMC network drive. 
 
12.DATA AND SPECIMEN BANKING 
All participants will be assigned a participant ID. Redcap and the Moms@Home app will be 
used for data collection and data banking. All digital data will be password protected and 
encrypted so that only research personnel can access stored data using the RedCap system. 
 
We will create a master list linking the study IDs to identifiers which will be stored in RedCap. 
Access to this master list will be limited to only members of the study team members that need to 
work on this list. We will destroy the master list of identifiers 6 years after study completion. We 
may use the de-identified research data in other future research. We may also share de-identified 
research data with researchers that are not part of UMass Chan. In these cases, we will not share 
names or other details that directly identify participants. 
Recordings from the focus groups will be destroyed after verification of notes. Detailed field 
notes, de-identified transcripts and linking documents, and codebooks will be maintained for 6 
years after study closure. The study team will ensure the appropriate files are deleted from the 
external hard drive, QMC drive, and SD card as specified.  
 
According to our study’s data management and sharing plan (DMSP), de-identified human 
subjects’ data from the study will be available in clinicaltrials.gov. “The final dataset will include 
de-identified self-reported demographic and behavioral data from participants and home blood 
pressure monitoring (HBPM) data from the Moms@Home app. If acceptable to NHLBI, we will 
work with the NHLBI BioData Catalyst (BDC) to deposit the appropriate data. Otherwise, this 
final dataset will be kept on hand and distributed upon reasonable request after an appropriate 
data-use agreement has been put in place. All data will be de-identified prior to release.” 
 
13.DATA ANALYSIS AND MANAGEMENT 
Provide a power analysis and/or support for the sample size proposed for this study  
Power calculations for this pilot trial are based on a 2-group, 2-sided Chi-square test of 
proportions with alpha=0.05. Assuming the intervention will improve HBPM adherence from 
10% to 35% (based on our prior work with non-pregnant adults with HTN), we will achieve 
80% power when the sample size is 43 per arm (N=86). We will recruit 100 participants to 
account for ~15% attrition. We base our proposed sample size also on pragmatic 
considerations related to recruitment, retention, and our focus on feasibility, providing 
important information for design and recruitment for a future R01 to test Moms@Home in a large 
RCT. 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 8 of 18 
Template 
Revised 03/15/2021 
 
Describe the data analysis plan, including any statistical procedures   
We will compare HBPM adherence (primary outcome) between the two arms (Moms@Home 
and ESC). Other outcomes (see section 10) will be compared using generalized estimating 
equations accounting for the appropriate distribution (e.g., binomial — dichotomous outcome 
such as HBPM adherence, or Poisson/Negative Binomial — count). We will quantify missing 
data and dropouts and examine reasons for ineligibility and discontinuation. All data 
distributions will be examined, and summary statistics calculated by group using an intention-
to-treat approach. We will also include other potential modifiers of the intervention effect, potential 
confounders, and other covariates of interest. In the event of possible effect modification, we will 
explore the nature of the relationship through the use of interaction terms and subsequent 
subgroup analysis. This approach will be used for measures with pre-post measurements as well 
as those collected post-implementation only. Although the pilot study may not have adequate 
statistical power for testing our hypotheses of improved BP control and medication adherence, 
we will conduct an exploratory analysis of any treatment effects. We will also examine HBPM 
adherence by race/ethnicity. Per-protocol analysis will also be performed using all data available 
from randomized participants without replacement of missing data. Goal attainment scaling, step 
count, and sleep duration will be characterised for each participant, and then compared between 
the Moms@Home and ESC groups using a Wilcoxon-Mann-Whitney rank-sum test. In an 
exploratory analysis, we will compare HBPM, BP control, activity, frequency of visits, and 
pregnancy outcomes between the primary groups and subgroups (stratified by race/ethnicity, 
health literacy, income level, age, obesity, and trimester). Qualitative analyses will use applied 
thematic and content analysis for post-intervention focus groups. All quantitative analyses 
will be conducted using SAS 9.4 or STATA version 18. We will estimate relevant parameters 
including estimates of trial retention, intraclass correlation coefficient, standard deviation, and 
effect size for future R01 power calculations. 
 
Describe any procedures that will be used for quality control and data security of collected 
data  
• Principles underlying our approach to quality control include: (1) standardization of 
measurements and interventions; (2) use of clear and specific protocols for all activities, 
including training for data collection, intervention, and data processing; (3) validation and 
verification of all data collection and management procedures through data editing, double 
entry of data, bias detection (e.g., digit preference or unexpected runs) and use of software 
capable of checking for out-of-range values and other sources of outliers; (4) 
implementation of a data cleaning protocol which includes checks for consistency and 
examinations of frequency tabulations; and (5) regular meetings and progress reports to 
provide specific, well-documented feedback to the project personnel concerning potential 
difficulties as well as sufficient follow-up to ensure that problems are resolved in a timely 
fashion. Any changes to data sets resulting from these queries will be recorded through an 
electronic audit trail.  
 
All data activities will occur in the context of reproducible research. Specifically, datasets 
and analyses will be generated under documented protocols and standard operating 
procedures that allow other investigators to replicate findings. All variables will have 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 9 of 18 
Template 
Revised 03/15/2021 
descriptive names and statistical programs will be annotated and archived, with the goal of 
making it easy to generate (and reproduce) research products. 
 
Computerized data forms and other records will be kept in UMass Chan Redcap and a 
network QMC drive behind its firewall, where access is restricted to authorized personnel 
(with access through network username and password). Backup paper copies kept in a 
separate, secure location in locked cabinets in locked offices accessible only to research 
staff. Electronic data back-ups will be performed at least daily. To protect against 
inappropriate access, we will first handle and transmit only de-identified data wherever 
possible. Data transmissions will be handled over secure VPN connections or other secure 
procedures, and data will be encrypted wherever feasible. Analytic datasets will be stripped 
of patient identifiers, with re-identifying master lists kept in a separate, secure place. 
 
• FitBit will have access to participant data from device (i.e. daily step count, heart rate and 
sleep data). When participant sign up for their FitBit account, they will agree to a privacy 
policy.(see here : Fitbit Legal: Privacy Policy). Each participant will be assigned a study 
ID and a study Fitbit login so that data is de-identified on export. FitBit is considered 
HIPAA approved and all information collected from device will remain confidential and 
will remain on secure servers.    
 
 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS 
This study has minimal risks to subjects and adverse events are not anticipated, therefore, there is 
no data safety committee.  
 
Study staff will monitor the Moms@Home platform twice daily and receive alerts for abnormal 
values (BP >140/90 mmHg). Study staff will call participants after the alert to ensure they 
reached the healthcare team or to direct participants to labor and delivery for severe elevations 
(BP >160/110 mmHg) or BP >140/90 mmHg with any preeclampsia symptoms. Similarly, we 
may encounter low BPs. For symptomatic systolic BP <90 mm Hg or DBP <50 mm Hg, 
participants will be instructed to call their OB/MFM office (symptoms, e.g., lightheaded, faint, 
experiencing vision changes, etc). 
 
As is the current practice in the OB/MFM clinics, out of range blood pressures in the ESC group 
will be the responsibility of the participant to communicate them to their OB/MFM team. All 
participants will be given the phone number for the research staff to call in case there are 
questions about HBPM measures during business hours. Outside of business hours, the ESC 
participants will be instructed to report abnormal values by making a phone call or Epic MyChart 
message to their OB/MFM caregivers.  
 
To protect participants against the risk of loss of confidential information, data abstractors will 
not be allowed to create or keep any other data records besides the formal records that will be 
created in the electronic data capture systems. We will obtain only the most limited personal 
identifiers as needed to accomplish the follow-up contact goals of the study, including patient 
name, email address, and other necessary information.  

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 10 of 18 
Template 
Revised 03/15/2021 
 
With regards to confidentiality, all patient data will be stored on a secure server accessed via 
encrypted devices only. All records with personal identifiers will be destroyed 6 years after  
completion of the study by shredding of the hard paper copy and destruction of the electronic 
files. Any participant with severe hypertension (described above in exclusion) will not be eligible 
for this study, and the participant’s primary Obstetrician or MFM will be notified of the severe 
range blood pressure.  
 
Although our study poses minimal risk to subjects and no adverse events are expected due to the 
nature of the study, we will follow the adverse event procedure of the UMass Chan Medical 
School. The current guidelines require that items meeting the criteria of prompt reporting (ex. 
harm experienced by a participant that is unexpected and probably related) will be reported to the 
IRB within 5 business days of the investigator becoming aware of the event. 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT 
Subjects may withdraw from the study at any given time during the study period. Participants 
can withdraw at any time before or during the follow up visit phase, by requesting their data not 
be utilized. Subjects will not be withdrawn without their consent unless the study is cancelled. 
 
16. RISKS TO SUBJECTS 
Minimal physical risk is involved in this study. The main risks to participants include 1) 
emotional reaction and stress in completing a health assessment and monitoring BP, 2) time 
taken to complete assessments/focus groups, and 3) potential breech of confidentiality of the 
collected individually identifiable data. We believe risks associated with participation in this 
research study to be minimal and of low likelihood.  
 
Regarding the risk of subjects’ personal information being lost or exposed, this is unlikely, and 
study staff will ensure to the best of their ability that information is protected. Given the risk of 
emotional reaction/stress to surveys, all participants will be taken through an overview of these 
surveys during the consent process to help them with their expectations of the surveys. The study 
Patient Advisory Board (as mentioned above) will be asked to vet and take sample surveys to 
ensure each survey does not exceed 30 minutes and surveys do not overwhelm study 
participants. 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS 
Participating in this RCT may increase understanding of the complications of hypertension and 
the value of home monitoring to improve blood pressure control to prevent these complications. 
There is no potential for benefit for participation in the focus groups. There is potential for 
improved BP control, self-efficacy, and BP awareness for patients who participate in this RCT.  
 
18. VULNERABLE POPULATIONS 
Pregnant women 
We will be enrolling women who are pregnant (please see section 6 for inclusion criteria) with 
the ability to consent to participate. There is no anticipated physical harm to the participant or the 
fetus.  
 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 11 of 18 
Template 
Revised 03/15/2021 
Children 
Children will not be included in this study. 
 
Prisoners 
Prisoners will not be included in this study. 
 
Adults Unable to Consent 
We will not include these patients in the study. 
 
UMass Chan/UMass Memorial employees or students may participate in the RCT or focus 
groups. Their student status or employment would not be influenced in any way if they do or do 
not participate. No one in the study team directly supervises or is fully responsible for any 
employees, students, interns or residents who could potentially be enrolled in this study. If any 
obstetrics and gynecology residents or attendings, maternal fetal medicine fellows or attendings, 
or cardiology fellows partially supervised by the PI or co-investigators are possible participants, 
a 3rd party research assistant or research coordinator will be asked to consent to avoid any 
possible coercion or undue influence. 
 
 
19. MULTI-SITE RESEARCH 
NA 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH 
We have partnered with the Community Engagement and Collaboration Core of the UMass 
Center for Clinical and Translational Science to convene a Patient Advisory Group (see above) 
to assist in study procedures as mentioned above. 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS 
Home BP measure results will be shared with Moms@Home participants through the 
Moms@Home portal. See Section 11 for how results will be shared with participants and their 
health care providers. A brief end-of-study flyer with the main study findings will be sent to all 
interested participants when the study is complete. 
 
22. SETTING 
Subjects will be identified and recruited in the four OB/MFM clinics at UMass Memorial 
Hospital (mentioned above) from where they are referred and from the UMass Memorial 
Hospital inpatient service to enroll in the study. Consenting will happen in private rooms at the 
OB/MFM clinics or in private rooms in the hospital. Subjects will be given adequate time to 
have all their questions answered and to carefully consider participation. EHR data collection 
and chart review will be done in the investigators’ private offices and in touch-down spaces in 
the clinic and hospital.  
 
23. RESOURCES AVAILABLE 
PI – The PI has led multiple research projects involving human subjects and has been involved 
in recruiting for several RCTs. The PI has training on clinical investigation and protection of 
human subjects through NIH coursework, time serving as an IRB committee member, and from 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 12 of 18 
Template 
Revised 03/15/2021 
fellowship training. The PI will be overseeing each supporting role of the study personnel and 
ensure that the study team has appropriate CITI training. The PI will help recruit participants and 
manage the Redcap database. The PI will train the study staff on the study protocol, the process 
of consenting, and how to administer the surveys. The PI will plan to spend at least 1 hour per 
week on oversite of the staff and updating the Redcap database. 
 
The Co-Investigators will assist the PI in research design and development, as well as analytic 
aspects and coding of the study. They will support in recruitment and informed consent 
procedures. 
 
Research Coordinator – The Research Coordinator will oversee recruitment through 
communication with our community partners and OB/MFM clinicians. This person will assist 
the PI and the Co-Investigators in implementing all aspects of the project. The research 
coordinator will be responsible for working with the research assistants. The Research 
Coordinator will ensure that all study staff have appropriate CITI training and are aware of the 
most current study protocol. The research coordinator will spend on average 4 hours per week 
enrolling patients and updating the Redcap database. 
 
Research assistants – The research assistants will be trained by the PI, co-investigators, or 
research coordinator on the protocol, the process of consenting, how to measure BP, and how to 
administer the surveys. Either the PI or co-investigators will demonstrate the consenting process 
with a participant and with the research assistant shadowing the process. They will be taught the 
process of informed consent. The research assistants will be taught to ensure that participants 
have a complete understanding of the purpose of the study, the surveys involved, the risks 
involved, and the demands placed upon them as a participant. They will be taught to determine 
capacity – the participant’s ability to acquire and retain knowledge about the study, and the 
ability to understand the consequences of giving consent. The research assistants will help to 
design recruitment flyers. They will interface with the OB/MFM clinics to screen for appropriate 
participants for the study. They will be trained to consent with the support of an interpreter. The 
research assistants will spend on average 4 hours per week enrolling patients and updating the 
Redcap database. 
 
Data analysts – will help manage the database on Redcap. They will help to input data into the 
Redcap database and analyze results. They will spend < 1 hour per week on the research process. 
 
All personnel involved will be CITI-trained and trained by the PI or co-investigators on the 
research protocols and their specific duties and responsibilities. Therefore, they will be 
adequately informed about the protocol, research procedures, and their duties and 
responsibilities. Study staff will devote ample time to conducting and completing the study 
procedures.  
 
24. LOCAL RECRUITMENT METHODS 
Invitation letters will also be sent through MyChart (patient portal) and to home addresses 5–7 
days before clinic visits with an opt-out link and phone number. Follow-up phone calls will be 
made to assess the interest of people who have not opted out and do not respond to the 
invitations 1-2 days before clinic visits. Participants will also be recruited through word of mouth 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 13 of 18 
Template 
Revised 03/15/2021 
and flyers (see attached, with QR code to link to Redcap). We will provide these recruitment 
materials to our community partners (see section 11). They will have the option to post the flyer 
to social media groups relevant to their communities. Community partners will also post flyers 
on church and community boards in areas where they know there will be high traffic.   
 
Participants will be screened for eligibility by study staff (see section 6). 
 
Participants who do not opt out and are eligible will be seen during their clinic visits and given 
further information about the study, as well as potential risks and benefits. If the participant is 
interested, the consent form will be shared with them and a more detailed conversation regarding 
the risks and benefits of enrollment will be had.  If consent is declined, the participant will be 
asked a few questions to collect information on why they are declining participation.  
 
To recruit the 10 OB/MFM providers, we will reach out in person or through personal e-mail 
invitations to individual providers who see patients enrolled in the study. We will also attend 
department meetings to advertise the opportunity until we reach the target number, aiming for 5 
high utilizers and 5 low utilizers (as described in section 11.) 
 
A study stipend will be provided to all participants who complete the baseline ($25) and 4-week 
($25) assessments. An additional $75 will be provided to participating subjects upon completion 
of the 8-week assessments and returning the BP monitor, FitBit, and Samsung phone (if 
applicable). Both arms of study participants will be eligible for these stipends, totaling $125. 
Moms@Home intervention group participants will be compensated $50 for completing the focus 
groups, and caregiver participants will be compensated $100 for completing focus groups.  
 
25. LOCAL NUMBER OF SUBJECTS 
We plan to enroll approximately 100 study participants for the RCT and 10 providers for the 
post-intervention provider focus groups (see section 11). 
 
26. CONFIDENTIALITY  
See sections 11, 12, and 13. De-identified data will be used whenever possible. 
 
With this submission, we have requested a HIPAA waiver which will allow us to conduct 
medical records review to prescreen potential subjects for eligibility before approaching the 
patient.  Since only minimal risks are involved in reviewing medical records, this will not 
adversely affect the rights and welfare of the patients.  However, we will make our best effort to 
protect patient confidentiality. Data will be collected on password protected and encrypted iPads 
directly into RedCap and through the Moms@Home app with unique study ID for participants. 
The MDH platform has been used for other research studies and has provided adequate 
protection for participant data collection.  
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
We have requested HIPAA waiver which will allow us to conduct medical records review to 
prescreen potential research subjects for eligibility before approaching the subject. Since only 
minimal risks will be involved for reviewing medical records, this will not adversely affect the 
rights and welfare of the subjects. Recruitment will take place solely in a private setting. 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 14 of 18 
Template 
Revised 03/15/2021 
Participants will be informed that participation is voluntary, and participants can change their 
mind at any time. The collection of any personal information will be limited to information 
necessary to conduct this research. Consent will be collected for all participants.  
 
The CITI-certified personnel will comply with HIPAA privacy rule to protect patients’ health 
information and confidentiality of personal information. Data will be entered into a secure 
RedCap database with a unique study ID (as described above in #26).  
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
This is a minimal risk study and will not have physical risks involved, therefore, no funds for 
compensation for research-related injury have been set aside. The following is in the ICF form, 
directed to the patient: 
“The University of Massachusetts Medical School does not provide funds for the treatment of 
research-related injury. If you are injured because of your participation in this study, treatment 
will be provided. You or your insurance carrier will be expected to pay the costs of this 
treatment. No additional financial compensation for injury or lost wages is available. You do not 
give up any of your legal rights by participating in this research. “ 
29. ECONOMIC BURDEN TO SUBJECTS 
NA. 
 
30. CONSENT PROCESS 
All staff will be trained by the PI or one of the co-investigators on how to consent (see section 23 
and 24). All staff will be provided with copies of the HRP- 090- SOP- Informed Consent Process 
for Research and HRP-091-SOP- Written Documentation of Consent pdfs. The consent process 
will take place in a private clinic or hospital room.  All participants will be allowed extra time to 
read the consent form through if interested. If a waiting period is requested by a potentially 
interested participant, they will be asked at subsequent clinic visits to participate. The consent 
document will include a number that participants can call if they change their mind about 
participation. We will clearly indicate that participation in the study is voluntary and is not going 
to affect the patient’s treatment plan. Informed consent through a RedCap e-consent with 
electronic signature field, with a back-up option of written informed consent depending on 
patient preference, will be sought for all RCT participants, and verbal consent as above for 
provider focus groups (see section 11). 
 
We will be obtaining consent for Spanish speaking subjects with the help of UMMH clinical 
interpreters and there will be an impartial witness (who understands both languages) present 
when an interpreter is used. We will have a short Spanish form with UMMS IRB approval for 
Spanish language speakers. We do not anticipate a significant population of Spanish speaking 
subjects based on enrollment in our intervention development studies. If we enroll more than 3 
Spanish speakers, we will translate the long-form consent and surveys into Spanish. 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
Consenting documentation will be scanned into EPIC.  
Verbal consent will be documented in Redcap (see section 11). 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 15 of 18 
Template 
Revised 03/15/2021 
 
32. DRUGS OR DEVICES 
This is not an IDE, IND, or abbreviated IDE study.The FitBit and its software does not qualify as 
a medical device according to the FDA guidance. 
 
 
33. REFERENCES 
1. 
Wu P, Haththotuwa R, Kwok CS, et al. Preeclampsia and Future Cardiovascular Health: 
A Systematic Review and Meta-Analysis. Circ Cardiovasc Qual Outcomes. 2017;10(2). 
doi:10.1161/CIRCOUTCOMES.116. 
003497 
2. 
Office of the Surgeon General (OSG). The Surgeon General’s Call to Action to Improve 
Maternal Health [Internet]. Washington (DC): US Department of Health and Human Services; 
2020 Dec. Available from: https://www.ncbi.nlm.nih.gov/books/NBK568220/ 
3. 
Rich-Edwards JW, McElrath TF, Karumanchi SA, Seely EW. Breathing life into the 
lifecourse approach: pregnancy history and cardiovascular disease in women. Hypertension. 
2010;56(3):331-334. doi:10.1161/HYPERTENSIONAHA.110.156810 
4. 
Huang C, Wei K, Lee PMY, Qin G, Yu Y, Li J. Maternal hypertensive disorder of 
pregnancy and mortality in offspring from birth to young adulthood: national population based 
cohort study. BMJ. 2022;379:e072157. doi:10.1136/bmj-2022-072157 
5. 
Jakubowski BE, Hinton L, Khaira J, Roberts N, McManus RJ, Tucker KL. Is self-
management a burden? What are the experiences of women self-managing chronic conditions 
during pregnancy? A systematic review. BMJ Open. 2022;12(3):e051962. doi:10.1136/bmjopen-
2021-051962 
6. 
Izzo JL. Barriers to blood pressure control initiatives: Regional diversity, inadequate 
measurement techniques, guideline inconsistencies, and health disparities. J Clin Hypertens 
(Greenwich). 2019;21(2):204-207. doi:10.1111/jch.13466 
7. 
Ayyala MS, Coughlin JW, Martin L, et al. Perspectives of pregnant and postpartum 
women and obstetric providers to promote healthy lifestyle in pregnancy and after delivery: a 
qualitative in-depth interview study. BMC Women’s Health. 2020;20(1):44. doi:10.1186/s12905-
020-0896-x 
8. 
López-Azpiazu I, Martínez-González MÁ, Kearney J, Gibney M, Martínez JA. Perceived 
barriers of, and benefits to, healthy eating reported by a Spanish national sample. Public Health 
Nutrition. 1999;2(2):209-215. doi:10.1017/S1368980099000269 
9. 
Siu AL, U.S. Preventive Services Task Force. Screening for high blood pressure in 
adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 
2015;163(10):778-786. doi:10.7326/M15-2223 
10. 
Racial Disparities in Maternal Health and Mortality. Accessed February 11, 2023. 
https://www.bcbs.com/the-health-of-america/reports/racial-disparities-in-maternal-health 
11. 
Fryer K, Munoz MC, Rahangdale L, Stuebe AM. Multiparous Black and Latinx Women 
Face More Barriers to Prenatal Care than White Women. J Racial Ethn Health Disparities. 
2021;8(1):80-87. doi:10.1007/ 
s40615-020-00759-x 
12. 
da Silva PHA, Aiquoc KM, da Silva Nunes AD, et al. Prevalence of Access to Prenatal 
Care in the First Trimester of Pregnancy Among Black Women Compared to Other 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 16 of 18 
Template 
Revised 03/15/2021 
Races/Ethnicities: A Systematic Review and Meta-Analysis. Public Health Rev. 2022;0. 
doi:10.3389/phrs.2022.1604400 
13. 
Muntner Paul, Shimbo Daichi, Carey Robert M., et al. Measurement of Blood Pressure in 
Humans: A Scientific Statement From the American Heart Association. Hypertension. 
2019;73(5):e35-e66. doi:10.1161/ 
HYP.0000000000000087 
14. 
Schwartz JE, Muntner P, Kronish IM, et al. Reliability of Office, Home, and Ambulatory 
Blood Pressure Measurements and Correlation With Left Ventricular Mass. J Am Coll Cardiol. 
2020;76(25):2911-2922. doi:10.1016/j.jacc.2020.10.039 
15. 
Ward AM, Takahashi O, Stevens R, Heneghan C. Home measurement of blood pressure 
and cardiovascular disease:  systematic review and meta-analysis of prospective studies. J 
Hypertens. 2012;30(3):449-456. doi:10.1097/HJH.0b013e32834e4aed 
16. 
Bellomo G, Narducci PL, Rondoni F, et al. Prognostic value of 24-hour blood pressure in 
pregnancy. JAMA. 1999;282(15):1447-1452. doi:10.1001/jama.282.15.1447 
17. 
Margolis KL, Asche SE, Bergdall AR, et al. Effect of home blood pressure 
telemonitoring and pharmacist management on blood pressure control: a cluster randomized 
clinical trial. JAMA. 2013;310(1):46-56. doi:10.1001/jama.2013.6549 
18. 
Reboussin David M., Allen Norrina B., Griswold Michael E., et al. Systematic Review 
for the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline 
for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A 
Report of the American College of Cardiology/American Heart Association Task Force on 
Clinical Practice Guidelines. Hypertension. 2018;71(6):e116-e135. 
doi:10.1161/HYP.0000000000000067 
19. 
Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with 
text-based remote monitoring in the management of postpartum hypertension: a randomised 
clinical trial. BMJ Qual Saf. 2018;27(11):871-877. doi:10.1136/bmjqs-2018-007837 
20. 
Hirshberg A, Sammel MD, Srinivas SK. Text message remote monitoring reduced racial 
disparities in postpartum blood pressure ascertainment. American Journal of Obstetrics & 
Gynecology. 2019;221(3):283-285. doi:10.1016/j.ajog.2019.05.011 
21. 
Ostchega Y, Zhang G, Kit BK, Nwankwo T. Factors Associated With Home Blood 
Pressure Monitoring Among US Adults: National Health and Nutrition Examination Survey, 
2011-2014. Am J Hypertens. 2017;30(11):1126-1132. doi:10.1093/ajh/hpx101 
22. 
Ostchega Y, Berman L, Hughes JP, Chen TC, Chiappa MM. Home blood pressure 
monitoring and hypertension status among US adults: the National Health and Nutrition 
Examination Survey (NHANES), 2009-2010. Am J Hypertens. 2013;26(9):1086-1092. 
doi:10.1093/ajh/hpt054 
23. 
Tang O, Foti K, Miller ER, Appel LJ, Juraschek SP. Factors associated with physician 
recommendation of home blood pressure monitoring and blood pressure in the US population. 
Am J Hypertens. 2020 Sep 10;33(9):852-859. doi:10.1093/ajh/hpaa093 
24. 
Boelig RC, Saccone G, Bellussi F, Berghella V. MFM guidance for COVID-19. Am J 
Obstet Gynecol MFM. 2020;2(2):100106. doi:10.1016/j.ajogmf.2020.100106 
25. 
Pealing LM, Tucker KL, Mackillop LH, et al. A randomised controlled trial of blood 
pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: A 
feasibility trial. Pregnancy Hypertension. 2019;18:141-149. doi:10.1016/j.preghy.2019.09.018 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 17 of 18 
Template 
Revised 03/15/2021 
26. 
Marko KI, Ganju N, Krapf JM, et al. A Mobile Prenatal Care App to Reduce In-Person 
Visits: Prospective Controlled Trial. JMIR mHealth and uHealth. 2019;7(5):e10520. 
doi:10.2196/10520 
27. 
Perry H, Sheehan E, Thilaganathan B, Khalil A. Home blood-pressure monitoring in a 
hypertensive pregnant population. Ultrasound Obstet Gynecol. 2018;51(4):524-530. 
doi:10.1002/uog.19023 
28. 
Tucker KL, Taylor KS, Crawford C, et al. Blood pressure self-monitoring in pregnancy: 
examining feasibility in a prospective cohort study. BMC Pregnancy Childbirth. 2017;17(1):442. 
doi:10.1186/s12884-017-1605-0 
29. 
Tucker KL, Sheppard JP, Stevens R, et al. Self-monitoring of blood pressure in 
hypertension: A systematic review and individual patient data meta-analysis. PLoS Med. 
2017;14(9):e1002389. doi:10.1371/journal.pmed.1002389 
30. 
Ohkubo T, Imai Y, Tsuji I, et al. Home blood pressure measurement has a stronger 
predictive power for mortality than does screening blood pressure measurement: a population-
based observation in Ohasama, Japan. J Hypertens. 1998;16(7):971-975. doi:10.1097/00004872-
199816070-00010 
31. 
Cairns AE, Tucker KL, Leeson P, et al. Self-Management of Postnatal Hypertension: The 
SNAP-HT Trial. Hypertension. 2018;72(2):425-432. 
doi:10.1161/HYPERTENSIONAHA.118.10911 
32. 
Kitt JA, Fox RL, Cairns AE, et al. Short-Term Postpartum Blood Pressure Self-
Management and Long-Term Blood Pressure Control: A Randomized Controlled Trial. 
Hypertension. 2021;78(2):469-479. doi:10.1161/HYPERTENSIONAHA.120.17101 
33. 
Whitaker KM, Ingram KH, Appiah D, et al. Pre-Pregnancy Fitness and Risk of 
Gestational Diabetes: A Longitudinal Analysis. Med Sci Sports Exerc. 2018 Aug;50(8):1613-
1619. doi:10.1249/MSS.0000000000001600 
34. 
Lupattelli A, Spigset O, Nordeng H. Adherence to medication for chronic disorders 
during pregnancy: results from a multinational study. Int J Clin Pharm. 2014;36(1):145-153. 
doi:10.1007/s11096-013-9864-y 
35. 
McManus DD, Trinquart L, Benjamin EJ, et al. Design and Preliminary Findings From a 
New Electronic Cohort Embedded in the Framingham Heart Study. J Med Internet Res. 
2019;21(3):e12143. doi:10.2196/ 
12143 
36. 
Spartano NL, Lin H, Sun F, et al. Comparison of On-Site Versus Remote Mobile Device 
Support in the Framingham Heart Study Using the Health eHeart Study for Digital Follow-up: 
Randomized Pilot Study Set Within an Observational Study Design. JMIR Mhealth Uhealth. 
2019;7(9):e13238. doi:10.2196/13238 
37. 
Arnaert A, Ponzoni N, Debe Z, Meda MM, Nana NG, Arnaert S. Experiences of women 
receiving mhealth-supported antenatal care in the village from community health workers in 
rural Burkina Faso, Africa. Digit Health. 2019;5:2055207619892756. 
doi:10.1177/2055207619892756 
38. 
Ahern DK, Woods SS, Lightowler MC, Finley SW, Houston TK. Promise of and 
potential for patient-facing technologies to enable meaningful use. Am J Prev Med. 2011;40(5 
Suppl 2):S162-172. doi:10.1016/ 
j.amepre.2011.01.005 

INVESTIGATOR STUDY PLAN – Moms@Home 
 V1.0 
 
                                                                                                                     Page 18 of 18 
Template 
Revised 03/15/2021 
39. 
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for 
diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 
2009;11(10):913-930. doi:10.1111/j.1463-1326.2009.01057.x 
40. 
Griffiths F, Lindenmeyer A, Powell J, Lowe P, Thorogood M. Why are health care 
interventions delivered over the internet? A systematic review of the published literature. J Med 
Internet Res. 2006;8(2):e10. doi:10.2196/jmir.8.2.e10