Clinical trial NCT05479097
Conditions: Hypertension
Sponsor: University of Wisconsin, Madison
Start date: 2023-02-06; Completion date: 2023-12-31
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a single group study assessing the feasibility of hypertension management by community health workers (CHWs) equipped with a mobile clinical decision support (CDS) application and working with remote physician supervision.

Detailed description:
An estimated 1.13 billion people worldwide are currently living with hypertension, the leading preventable cause of death and disability. Two thirds of these patients live in low- and middle-income countries (LMIC). Treatment of hypertension has been found to be cost-effective in reducing morbidity and mortality across a broad range of settings. Despite this, less than 10% of patients with hypertension in LMIC have good control of their blood pressure. Health systems in LMIC, which are often focused on providing episodic care for acute illnesses and suffer from inadequate and poorly distributed health care infrastructure and workforce, are ill-equipped to address the rise in chronic non-communicable diseases (NCDs) such as hypertension. Governments and NGOs are increasingly turning to community health workers (CHWs) - lay people trained to carry out a variety of tasks and who often are from or have a close connection to the communities they serve - to help fill care gaps for hypertension and other NCDs in LMIC. In most cases, CHWs have played supportive (e.g. providing patient education) rather than direct care roles. While such programs have led to improved chronic disease outcomes, they still rely on clinic-based physicians, mid-level providers or nurses to directly provide medical management, and therefore do not address the essential problem of inadequate primary care infrastructure and workforce, particularly in rural areas. Overcoming this problem is key to reducing the growing burden of untreated hypertension in LMIC.

To solve this problem, the investigators are developing an innovative mobile application to assist CHWs in the treatment of hypertension in adults with remote physician supervision. This application is built on the widely-used CommCare platform and will provide clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care. The investigators will develop and test this approach in a rural area of Guatemala with poor primary care infrastructure and where the team has worked extensively in the past and has an ongoing collaboration with a local NGO, the San Lucas Mission, and affiliated CHWs. Through this collaboration, the investigators have developed and implemented a CHW-led rural diabetes program enabled by a CDS mobile application and have demonstrated that CHWs can safely and effectively manage diabetes using the application. The hypothesis is that the investigators will be able to adapt the model to hypertension management and are evaluating the feasibility of this approach with this pilot study.

Interventions: intervention 1: Anti-Hypertensive
Intervention descriptions: intervention 1: Based on information entered by the CHWs into the CommCare application designed for this study, the application will provide recommendations (and underlying rationale for these recommendations) for prescription of antihypertensives (amlodipine and/or losartan OR enalapril) and medications to reduce cardiovascular risk (aspirin and atorvastatin) if indicated, lifestyle modification, and referral to the supervising physician if indicated for potential complications of hypertension.

Protocol documents:
ICF_002.pdf: 
Official Title: A feasibility study of a novel mHealth clinical decision support application to
enable community health workers to manage hypertension with remote physician supervision
NCT number: NCT05479097
Document description: Consent forms (English and Spanish versions)
Document date: 01/27/2023


University of Wisconsin - Madison
Research Participant Information and Consent Form
                 
Study Title: A feasibility study of a novel mHealth clinical decision support application to enable 
community health workers to manage hypertension with remote physician supervision
Principal Investigator:  Sean Duffy MD (Phone: 608-354-7930) 
  (Email: sean.duffy@fammed.wisc.edu)
                 
Description of the research
You are invited to participate in a research study to see if community health workers can medically 
manage high blood pressure (hypertension) in patients from rural communities.  This project is 
important because it will show if community health workers, when aided by mobile applications for 
clinical decision support (called CommCare), can take care of your high blood pressure.  
Hypertension is the leading preventable cause of death worldwide.  Small improvements in 
hypertension control could have an effect on the health of many.
You have been asked to take part in this project because you have been told that you have high 
blood pressure.
The purpose of the research is to see if community health workers (CHW) can manage high blood 
pressure (hypertension) in patients from rural communities.
This study will include 30 people from rural communities of the San Lucas Toliman municipality 
(Guatemala).  This research will be conducted at your rural clinic or in your home.
                 
What will my participation involve?
If you decide to participate in this research, you will be asked to meet with a community health 
worker (CHW) at an enrollment visit and monthly thereafter.  All study data will be collected using a 
mobile application running on a smartphone. At enrollment, information on basic demographic 
information (age, race, sex), past medical history, and current medications will be collected. CHWs 
will measure blood pressure, height, and weight. Patients will also be asked to complete some 
surveys. You will be asked about any side effects from your current medications and asked about 
any signs or symptoms of possible problems from high blood pressure, including ischemic heart 
disease, cerebrovascular disease, heart failure, and kidney disease. You will have blood drawn and 
the blood sample will be tested for lipids (fats), serum creatinine, electrolytes, and blood glucose 
(sugars). Based on the information entered by the CHWs into the mobile application designed for 
this study, the application will provide advice for the prescription of medications to lower blood 
pressure and additional medications to reduce cardiovascular risk if indicated, lifestyle changes, and 
referral to the supervising physician if indicated for potential problems of hypertension. CHWs will 
then provide you with these treatments assisted by recommendations from the application. Your 
care plan will be reviewed by a medical doctor each month and the CHWs will also be able to 
consult with a doctor at any time for advice on your care.
Your participation will last approximately 60-90 minutes per session and will require 7 sessions      
which will require 7-11 hours in total.
                 
IRB Approval Date: 1/27/2023              
University of Wisconsin – Madison


Are there any risks to me?
There are always risks when taking medications.  The medications selected for this project are 
known to be safe and you will be monitored for potential side effects. Your personal and medical 
information will be collected and there is a risk of a potential loss of your private information. Also, 
blood pressure measurements and blood draws can cause some discomfort.
                 
Are there any benefits to me?
The primary potential benefit to participants is improved treatment of hypertension and 
management of cardiovascular risk factors, leading to less risk of cardiovascular events, other 
complications of uncontrolled hypertension, and mortality. 
                 
How will my confidentiality be protected?
Confidentiality means that we will keep your personal information protected.  Your information will 
be protected by having all study visits performed in a private room or, at a minimum, out of earshot 
of other people. Data will be collected on encrypted, password-protected smartphones using the 
CommCare application, which is also password protected and encrypted. Study data will be stored 
on CommCare's secure server, which is HIPAA compliant, secure University of Wisconsin servers, 
and secure computers in Guatemala. Any hard copies of data containing your personal health 
information will be stored in locking filing cabinets in controlled-access facilities.
Only approved personnel working on this project will have access to the data.
Protected health information (PHI), is information about your physical or mental health that 
includes your name or other information that can identify you. To do this study, we will use things 
you tell the research team about your health.
Your authorization for researchers to use your PHI does not have an end date.  However, you can 
choose to take back your authorization for researchers to use your health information.  You can do 
this at any time before or during your participation in the research. If you take back your 
authorization, you will not be able to take part in the research study. To take back your 
authorization, you will need to notify the researchers.
The information collected in this study, including your health information, may be used or shared 
for future related research.
                 
Whom should I contact if I have questions?
You may ask any questions about the research at any time. If you have questions, concerns, or 
complaints, or think that participating in the research has hurt you, talk to the research team or 
contact the Principal Investigator Sean Duffy MD at 608-354-7930 (phone or WhatsApp).
                 
If you have any questions about your rights as a research patient or have complaints about the 
research study or study team, call the confidential research compliance line at 1-833-652-2506. 
Staff will work with you to address concerns about research participation and assist in resolving 
problems.
                 
Any participation in research study is completely voluntary.  If you decide not to participate or to 
withdraw from the study, you may do so without penalty.
                 
IRB Approval Date: 1/27/2023              
University of Wisconsin – Madison


Your signature indicates that you have read this consent form, had an opportunity to ask any 
questions about your participation in this research and voluntarily consent to participate. You will 
receive a copy of this form for your records.
                 
Name of the Participant (please print): __________________________________________
                 
Signature: _________________________________________________________________
                 
Date: _____________________________________________________________________
                 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This website will 
not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time.
IRB Approval Date: 1/27/2023              
University of Wisconsin – Madison

Prot_000.pdf: 
Official Title: A feasibility study of a novel mHealth clinical decision support application to
enable community health workers to manage hypertension with remote physician supervision
NCT number: NCT05479097
Document description: Study protocol
Document date: 10/2/2023


PRINTED ON: 6/14/2024
1 / 46
University of Wisconsin-Madison
MR IRB Application
Study # : 2022-0794
Principal Investigator:
Sean Duffy
Basic Study Information
1. Formal Title
This is the title that will appear in correspondence.
* Provide the full, formal study title.
A feasibility study of a novel mHealth clinical decision support application to enable
community health workers to manage hypertension with remote physician supervision
 
2. Transferred Study
Answer Yes to this question only if:
a) the principal investigator (PI) for this application is coming to UW-Madison, UW
Health, or the Madison VA from another institution and,
b) they plan to open a study here that is already IRB-approved at their previous
institution.
* Is this study being transferred from another institution?
  
Yes 
No
3. Principal Investigator
* Identify the Principal Investigator.
Sean Duffy
Type of Research Application
1. Type of Research Application


PRINTED ON: 6/14/2024
2 / 46
* Select one of the following: Full review
PI Information
1. Principal Investigator
PI : Sean Duffy
2. Primary Appointment
* Is the PI’s primary appointment through the University of Wisconsin
– Madison?
  
Yes 
No
2.1. Appointment Details
* Identify the appointment under which the PI will conduct this
research.
 
Title
Type UDDS
Department Combined Name
Assistant Professor
(CHS)
AS
A532050 SMPH/FAMILY MED/CLINIC
WINGRA
2.2. Appointment Not Found
Check if the appointment is not listed above.   
Protocol Feasibility
School of Medicine and Public Health policy 70.10 requires departments to
assess and document the feasibility of non exempt human subjects
research prior to IRB review.
SMPH departments are required to evaluate and confirm local capacity
(e.g., qualified staff, adequate resources and facilities, sufficient patient


PRINTED ON: 6/14/2024
3 / 46
population) to warrant pursuit of a research study. Feasibility assessments
help identify and address potential factors that can prevent or slow study
execution.
Please see https://ictr.wisc.edu/protocol-feasibility/ for guidance and
to download the “Research Feasibility Attestation Form.”
1. Research Feasibility Attestation Form
Upload the signed "Research Feasibility Attestation Form."
There are no items to display
Study Team
1. Points of Contact Selection
Points of contact can edit the application and will receive email notifications about this
submission.
Please do not use personal email addresses (e.g., Gmail, Hotmail, etc.). A campus
business email can be changed following the instructions here.
If the PI is serving as the only study point of contact, indicate that here.
Can’t find someone in the chooser? See this FAQ for help.
To register a NetID, click here.
* Identify the points of contact for this study (limit of four).
Name
Email
Mary Checovich
mary.checovich@fammed.wisc.edu
Taryn Valley
tmvalley@wisc.edu
2. All Other Study Team Personnel
List ONLY UW-Madison, UW Health, or Madison VA personnel. External personnel will be
listed elsewhere in the application.
Please do not use personal email addresses (e.g., Gmail, Hotmail, etc.). A campus
business email can be changed following the instructions here.


PRINTED ON: 6/14/2024
4 / 46
Study team members listed below will have read-access only and will not be able to edit
the application. They also will not receive email notifications.
Can’t find someone in the chooser? See this FAQ for help.
To register a NetID, click here.
List all the other members of the study team (not including the PI or
points of contact).
Name
Email
Valerie Aguilar
vaguilar@wisc.edu
Juan Aguirre
jjaguirre@wisc.edu
Ian Arthur
iarthur@wisc.edu
Alvaro Bermudez-Canete
bermudezcane@wisc.edu
Guanhua Chen
gchen25@wisc.edu
Pablo Nunez Perez
nunezperez@wisc.edu
Kaitlin Tetreault
tetreault2@wisc.edu
Elizabeth White
eawhite4@wisc.edu
Study Team Roles
1. Primary POC
If the PI is serving as the primary point of contact, indicate that here.
* Identify the primary point of contact for this study.
Mary Checovich
2. Human Subject Involvement
* Does this study involve recruiting, consenting, or interacting with
human subjects?
  
Yes 
No
2.1. Study Team Details
For each study team member below, click the D button and check the boxes to indicate
that study team member's roles for this study. Note: Some study team members may not
have any roles listed below.


PRINTED ON: 6/14/2024
5 / 46
Tell us which study team members will: recruit human subjects, obtain
informed consent from human subjects, interact with human subjects, or
perform cognitive assessments on human subjects.
Study Team Member
Recruit
Subjects
Obtain Informed
Consent
Interact with
Subjects
Valerie Aguilar
 
 
yes
Juan Aguirre
 
 
yes
Ian Arthur
 
 
yes
Alvaro Bermudez-Canete
 
 
 
Mary Checovich
 
 
 
Guanhua Chen
 
 
 
Sean Duffy
yes
yes
yes
Pablo Nunez Perez
 
 
 
Kaitlin Tetreault
 
 
 
Taryn Valley
 
 
yes
Elizabeth White
 
 
 
Funding
1. Funding Administered by UW Madison
Answer no to this question if this study will only be supported by VA funding; you will
have the opportunity to add VA funding later in the application.
* Do you have pending or approved funding administered through
Research and Sponsored Programs (RSP) or Business Services to
support this project?
  
Yes 
No
1.1. Funding Sources
For federal funds, pending sources may be listed if the grant has received a
highly meritorious score. For example, an impact score of <30 is an indication of
a highly meritorious NIH grant proposal. Receipt of a request for Just In Time
(JIT) documentation is another indication of a highly meritorious proposal.


PRINTED ON: 6/14/2024
6 / 46
For non-federal funds, pending sources may be listed if you have confirmation
from the sponsor that funding will be awarded due to merit AND the sponsor has
a peer-review process.
For industry, do not select industry sponsors who are only providing
drug/device OR only limited support for the study.
* Use this chooser to select each funding source administered
through UW-Madison that will support this study or project.
 
Funding Source Details
View
PI Name
Duffy,Sean  
Proposal
ID
MSN245065  
Award ID
MSN245065  
Funding
Title
mHealth to Enable Task Sharing for Hypertension Care in
LMIC  
Project ID
No Value Entered  
Sponsor
(Source)
DHHS, PHS, NATIONAL INSTITUTES OF HEALTH  
Sponsor
Reference
Number
1R21TW011891-01  
Primary
Sponsor
No Value Entered  
Primary
Sponsor
Reference
Number
No Value Entered  
Federal
Yes  
Status
Active  
Start
Date
8/10/2021  
End Date
4/30/2026  
2. Other Funding
* Do you have pending or approved funding NOT listed on this page?
  
Yes 
No


PRINTED ON: 6/14/2024
7 / 46
Conflict Of Interest
Please review the study team member Outside Activities Report (OAR) and
managed entities data below before answering the questions on this page.
The following study team members have not completed
their OAR for the year:
Valerie Aguilar, Juan Aguirre, Ian Arthur, Alvaro Bermudez-
Canete, Pablo Nunez Perez, Taryn Valley, Elizabeth White
NOTE: Per campus policy all study team members must
submit an OAR every year and keep it up to date.
No study team members have any managed entities at
this time.
1. Intellectual Property
* Do any study team members involved in the design or conduct of
the research (including their spouses and dependent children) own
intellectual property that will be used in the study or project?
  
Yes 
No
2. Other Entities
* Besides the sponsor(s) of this project or entities listed above, do
any study team members have a fiduciary or financial relationship with
entities that will be involved in this study or that may be significantly
affected by it?
  
Yes 
No
3. Incentives


PRINTED ON: 6/14/2024
8 / 46
* Do any of the study team receive any incentives for recruiting
human subjects or any other purpose directly related to the study or
project?
  
Yes 
No
VA Status
All studies that fall under Madison VA purview must be reviewed and
approved by the VA Research and Development (R&D) Committee in
addition to being reviewed by the Health Sciences IRB. For information
about the VA R&D Committee review process, please contact
VHAMADRDCoordinator@va.gov.
1. VA Status
* Does this study involve the Madison VA (Wm. S. Middleton VA
Hospital); e.g., funding from the VA, conducted under VA appointment,
use of VA facility, recruitment of veterans or use of their data or
samples at the Madison VA?
  
Yes 
No
Scientific Review: PRMC & CRU
1. Cancer Related
* Is the scientific question of the protocol cancer related?
  
Yes 
No 
2. Targeting Cancer Patients
* Are you specifically targeting cancer patients for enrollment in this
study?
  
Yes 
No 


PRINTED ON: 6/14/2024
9 / 46
3. Use of Cancer Data or Images
* Does this study involve the review and/or use of biological
specimens/data/images/records from cancer patients?
  
Yes 
No 
4. Use of CRU
If the answer to this question is Yes, you must upload a copy of the CRU application to
the Submit activity form.
* Will this study use the Clinical Research Unit (CRU)?
  
Yes 
No 
ClinicalTrials.gov Information
This page is designed to aid in identifying ClinicalTrials.gov registration
requirements. Registration may be required by the FDA, NIH, or if you are
planning to publish in a journal that follows International Committee of
Medical Journal Editors (ICMJE) guidance. Please answer each question
carefully.
UW-Madison has a free service available to assist you in registering your
record with ClinicalTrials.gov. Contact CT.gov_Help@clinicaltrials.wisc.edu
for more information.
For information on registration and results reporting requirements see our
KnowledgeBase page or contact the Office of Research Compliance at
ClinicalTrials.gov_Support@research.wisc.edu.
1. Study Intervention(s)
Prospective assignment means enrolling study subjects and collecting data on them
in the future. It is a study not solely reliant on existing or retrospective data. It is not a
requirement to have multiple groups or arms for a study to be considered prospectively
assigned.


PRINTED ON: 6/14/2024
10 / 46
An intervention is any manipulation of the subject or subject's environment for the
purpose of modifying one or more health-related biomedical or behavioral processes
and/or endpoints. Any study that is not observational (where participants may receive a
drug, device, medical procedure, or behavioral intervention as part of their standard
clinical care) should be considered interventional. Examples include: drugs/small
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques);
delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change
health-related behavior (e.g., diet, cognitive therapy, exercise, development of new
habits); treatment strategies; prevention strategies; and, diagnostic strategies.
A health-related biomedical or behavioral outcome is defined as the pre-specified
goal(s) or condition(s) that reflect the effect of one or more interventions on human
subjects’ biomedical status, behavioral status, or quality of life. Examples include:
positive or negative changes to physiological or biological parameters (e.g., improvement
of lung capacity, gene expression); positive or negative changes to psychological or
neurodevelopmental parameters (e.g., mood management intervention for smokers;
reading comprehension and /or information retention); positive or negative changes to
disease processes; positive or negative changes to health-related behaviors; and,
positive or negative changes to quality of life.
* Are subjects prospectively assigned by the protocol to any
intervention(s) that are being evaluated for any health-related
biomedical or behavioral outcomes?
  
Yes 
No 
2. ClinicalTrials.gov Determinants
* Check the box(es) that apply to this study:
NIH funded, when registration is a required condition of the grant (consult your award
letter or with your NIH Program Officer if unsure)
3. FDA or NIH Requirement
* Based on your responses, registration with ClinicalTrials.gov may be
required by the FDA or NIH. Will UW-Madison (study team or service
line support staff) register the study with ClinicalTrials.gov?
  
Yes 
No 


PRINTED ON: 6/14/2024
11 / 46
External Collaborations
1. Outside UW Activities
* Will any UW/UW Health or Madison VA personnel conduct any of
the following study activities at locations outside the UW/UW Health
or Madison VA: subject recruitment, obtaining informed consent, or
interacting or intervening with subjects?
  
Yes 
No 
1.1. Describe Activities at Non-UW Locations
* Describe what activities will be occurring outside the
UW/UW Health or Madison VA and at which locations.
Recruitment of subjects and all study activities will occur in the rural
communities of the municipality of San Lucas Tolimán at mobile clinics run
by our Guatemalan partner, the San Lucas Mission (SLM).
 
 
2. Requesting UW Serve as IRB
Please note that you must consult with RELIANT before you submit a request for the
UW to serve as the reviewing IRB for external sites or individuals. A consultation may be
requested here.
* Are you requesting that UW Madison serve as the reviewing IRB for
any external sites or individuals?
  
Yes 
No 
2.1. External Entity Type
Sites with an IRB or FWA typically include universities and larger hospitals or
health systems. A database of current FWAs and IRB registrations can be found
here: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-and-fwa-
status/index.html
Individuals not affiliated with an entity with an IRB or FWA typically include
people working with community organizations, schools, or non-profits.


PRINTED ON: 6/14/2024
12 / 46
* Indicate for which of the following you are requesting that
UW Madison serve as the reviewing IRB.
Individuals not affiliated with an entity with an IRB or Federalwide Assurance
(FWA)
3. Study Team Responsibilities
See: Study Team Responsibilities When UW Madison is Serving as the
Reviewing IRB
* Do you confirm the study team has reviewed and will meet the
responsibilities described in Study Team Responsibilities When UW
Madison is Serving as the Reviewing IRB?
  
Yes 
No 
Reviewing IRB: Individuals
Use this page to list individuals for whom you are requesting UW Madison
serve as the reviewing IRB. Individuals listed on this page should only be
those unaffiliated with an entity with an IRB or Federalwide Assurance
(FWA). Please contact the Reliance Team Reliance and Navigation Team
(RELIANT) (irbreliance@wisc.edu) with any questions about who should be
listed on this page.
1. External Individuals
Using the add button below, list each individual for whom UW Madison
will serve as IRB of record.
Full
Name
Organizational
Affiliation
Identify
Recruit
Subjects
Interact
With
Subjects
Obtain
Informed
Consent
Other
Human
Subjects
Training
Good
Clinical
Practice
Training
Training Docu


PRINTED ON: 6/14/2024
13 / 46
Olga
Ajcalon
San Lucas
Mission
yes
yes
yes
Training and
supervision of
community
health workers
11/24/2024 
2022-
0794_Ajcalon_
Audelina
Alvarez
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Audelina Alvare
Miriam
Marisol
Alvarez
San Lucas
Mission
yes
yes
yes
 
11/10/2024 
Miriam Alvarez 
Carmen
Castro
Calabay
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Carmen Castro
2.pdf(0.01)
Cesia
Castro
Chuta
San Lucas
Mission
yes
yes
yes
Training and
supervision of
community
health workers
11/24/2024 
2022-
0794_CastroCh
Alejandro
Chavez
independent
contractor
no
no
no
Mobile
application
design,
community
health worker
training,
technical
support and
troubleshooting
6/13/2024  
Acuerdo de Inv
Alejandro.pdf(0
Alejandro
Chavez
independent
contractor
no
no
no
Mobile
application
design,
community
health worker
training,
technical
support and
troubleshooting
6/13/2024  
Alejandro Chav
2021.pdf(0.01)
Guisela
Coche
Castro
San Lucas
Mission
yes
yes
yes
 
11/11/2024 
Guisela Coche 
Maria
Elena
Coraxon
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Maria Elena Co
Martha
Coz
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Martha Coz IIA
Amparo
Rita Culan
Pérez
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Amparo Rita C
Alma
Veronica
Florian
San Lucas
Mission
yes
yes
yes
 
11/10/2024 
Alma Veronica 
Silvia
Esperanza
Garcia
San Lucas
Mission
yes
yes
yes
 
11/10/2024 
Silvia Garcia II
Samuel
Gonzales
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Samuel Gonzal
Magaly
Guarcas
Batzibal
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Magaly Guarca


PRINTED ON: 6/14/2024
14 / 46
Dora
Maribel
Hernandez
Perez
San Lucas
Mission
yes
yes
yes
 
11/10/2024 
Dora Hernande
Clavelina
Leon
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Clavelina Leon 
Yoselin
Emelina
Letona
Lopez
San Lucas
Mission
yes
yes
yes
 
5/27/2025  
Yoselin Letona
Ana
Teresa
Lopez
Martin
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Ana Lopez Mar
Jose
Vicente
Macario
San Lucas
Mission
yes
yes
yes
 
11/24/2024 
2022-
0794_Macario_
Romelia
Macario
Cosigua
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Romelia Macar
Renato
Martin
Perez
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Renato Martin 
Blanca
Meijia
Xamba
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Blanca Meijia X
Clara
Culan
Perez
San Lucas
Mission
yes
yes
yes
 
11/10/2024 
Clara Perez IIA
Sonia
Perez
San Lucas
Mission
yes
yes
yes
 
11/24/2024 
Sonia Perez IIA
Roxana
Pilo Lopez
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Roxana Pilo Lo
Ingrid
Recinos
San Lucas
Mission
yes
yes
yes
 
3/2/2026
 
Ingrid Maribel 
Abelino
Sabuc
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Abelino Sabuc 
Ana
Patricia
Sabuc
Mejia
San Lucas
Mission
yes
yes
yes
 
11/10/2024 
Ana Patricia M
Dominga
Salazar
San Lucas
Mission
yes
yes
yes
 
11/24/2024 
2022-
0794_Salazar_
Saira
Noemi
Sequec
Macario
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Saira Macario 
Yolanda
Alian
Sicay
Cutuj
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Yolanda Alian S
2.pdf(0.01)
Manuela


PRINTED ON: 6/14/2024
15 / 46
Simalaj
Coraxon
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Manuela Simala
Candelaria
Tobar
Salugui
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Candelaria Tob
Yuli
Elizabeth
Toc Chuc
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Yuli Elizabeth T
Mariluvia
Tos Buch
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Mariluvia Tos B
Maria Tun San Lucas
Mission
yes
yes
yes
 
11/10/2024 
Maria Tun IIA 2
Rafael Tun San Lucas
Mission
no
yes
no
Local medical
director, co-
investigator.
Supervise
community
health workers
carrying out
study activities
7/9/2024
 
Rafael Tun - C
Training 2021.p
Telma
Viridiana
Gomez
San Lucas
Mission
yes
yes
yes
 
6/16/2026  
Telma Viridiana
2.pdf(0.01)
Delfina
Xiap
Chenol
San Lucas
Mission
yes
yes
yes
 
7/26/2025  
Delfina Xiap Ch
Sharing Data Outside UW
1. Sharing Data Outside UW Madison
* Will subject data, images, or specimens be shared outside the UW
Madison?
  
Yes 
No 
2. Sending Data or Specimens
* Select which of the following will be released outside the UW
Madison/Madison VA (Wm. S. Middleton VA Hospital).
Data

Images


PRINTED ON: 6/14/2024
16 / 46

Specimens
3. Recipients
Select the entities with whom the data, images, or specimens will be
shared.
Institution Name
Smart IRB Member
AAHRPP Accredited
Other
There are no items to display
4. Other External Recipients
For entities or individuals not listed above, list them here.
Data will be shared with Guatemalan team members affiliated with the San Lucas
Mission (health promoters and physicians).
 
5. Purpose of Sharing Data or Specimens
* Describe the purpose of sending the data, images, or specimens to
each recipient site. If data, images, or specimens will be included in
registry or repository, state that below.
These team members will be interacting with subjects, collecting study data,
contacting subjects for the follow-up study visit if applicable, and providing or
arranging clinical care for subjects as necessary.
 
6. Information Included
* Describe what information will be included with the data, images,
or specimens that will be shared.
Patient demographic and contact information, past medical history, social history,
vital signs, medication list, information on current symptoms, lab test results.
 


PRINTED ON: 6/14/2024
17 / 46
7. Identifiability
* Select the level of identifiability of the data, images or specimens
being shared.
Directly Identifiable

Coded (i.e., indirectly identifiable)

Anonymous (i.e., de-identified)
8. Transmitting Data or Specimens
* Describe how the data, images, or specimens will be transmitted
(e.g. Box) and how confidentiality will be protected (e.g., who
maintains the key code).
Guatemalan study team members will access subject data through the secure,
HIPAA-compliant CommCare platform. The CommCare application itself is encrypted
and password- protected and will only be accessed on password-protected Android
devices and Windows computers, which will be kept in a locked cabinet or room
when not in use.
 
9. Return of Data or Specimens
* Address whether the data, images or specimens will be returned to
UW Madison and if not, why not (e.g., samples will be exhausted).
Data will be shared with study personnel at UW Madison through the CommCare
platform, but will also be retained with San Lucas Mission staff for purposes of
ongoing patient care.
 
10. Informing Subjects
* Are subjects being informed of the plans to share data, images, or
specimens?
  
Yes 
No   


PRINTED ON: 6/14/2024
18 / 46
Study Procedures and Special Populations
1. Study Procedures Involved
Select "Review or use of information from health care records"
* If your study involves any of the following special procedures or
considerations, additional information may be needed. Select all that
apply. If none apply, check Not Applicable.
Interviews, focus groups, surveys, questionnaires, assessments (e.g., QOL, SCID, BDI,
etc.)
International Research
2. Special Populations
If you will collect data points identifying individuals as any of the following, select the
corresponding box(es).
* Is the research designed to include any of the following
populations? Select “Not Applicable” if the research will not include
any of the populations below. NOTE: If enrolling pregnant women,
children, or prisoners, and you can identify them as such, check the
box.
Illiterate or Low-literacy participants
Non-English Speaking subjects or subjects whose primary language is not English
Poor/uninsured, elderly/aged, or educationally disadvantaged
Research Design and Procedures
1. Overall Purpose
Describe the research questions or gap in knowledge the study proposes to address or
contribute to in language that someone who is educated but not an expert in the field
can understand.


PRINTED ON: 6/14/2024
19 / 46
* What is the overall purpose and aim of this project or study?
This is a single group study assessing the feasibility of hypertension management by
community health workers (CHWs) equipped with a mobile clinical decision support
(CDS) application and working with remote physician supervision.
2. Pre-Existing Information/Background Knowledge
* What prior information or knowledge exists to support the conduct
of this project or study?
An estimated 1.13 billion people worldwide are currently living with hypertension, the
leading preventable cause of death and disability.[1,2] Two thirds of these patients
live in low- and middle-income countries (LMIC).[1,2] Treatment of hypertension has
been found to be cost-effective in reducing morbidity and mortality across a broad
range of settings.[3] Despite this, less than 10% of patients with hypertension in
LMIC have good control of their blood pressure.[2] Health systems in LMIC, which
are often focused on providing episodic care for acute illnesses and suffer from
inadequate and poorly distributed health care infrastructure and workforce, are ill-
equipped to address the rise in chronic non-communicable diseases (NCDs) such as
hypertension.[4–6] Governments and NGOs are increasingly turning to community
health workers (CHWs) - lay people trained to carry out a variety of tasks and who
often are from or have a close connection to the communities they serve - to help
fill care gaps for hypertension and other NCDs in LMIC.[7–10] In most cases, CHWs
have played supportive (e.g. providing patient education) rather than direct care
roles. While such programs have led to improved chronic disease outcomes, they still
rely on clinic-based physicians, mid-level providers or nurses to directly provide
medical management, and therefore do not address the essential problem of
inadequate primary care infrastructure and workforce, particularly in rural areas.
Overcoming this problem is key to reducing the growing burden of untreated
hypertension in LMIC.
To solve this problem, we are developing an innovative mobile application to assist
CHWs in the treatment of hypertension in adults with remote physician supervision.
This application is built on the widely-used CommCare[11] platform and will provide
clinical decision support (CDS) to CHWs based on protocols from the WHO[12,13]
and the International Society of Hypertension[14] for antihypertensive medication
initiation and titration, lifestyle counseling, and identification of patients requiring a
higher level of care. We will develop and test this approach in a rural area of
Guatemala with poor primary care infrastructure and where our team has worked
extensively in the past and has an ongoing collaboration with a local NGO, the San
Lucas Mission, and affiliated CHWs. Through this collaboration, we have developed
and implemented a CHW-led rural diabetes program enabled by a CDS mobile
application and have demonstrated that CHWs can safely and effectively manage
diabetes using the application.[15,16] We hypothesize that we will be able to adapt
the model to hypertension management and are evaluating the feasibility of this
approach with this pilot study.
[1] World Health Organization. Hypertension Fact Sheet 2019.
https://www.who.int/news-room/fact-sheets/detail/hypertension (accessed
November 13, 2019).
[2] Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, et al. Global


PRINTED ON: 6/14/2024
20 / 46
Disparities of Hypertension Prevalence and Control: A Systematic Analysis of
Population-Based Studies From 90 Countries. Circulation 2016;134:441–50.
[3] Zhang D, Wang G, Joo H. A Systematic Review of Economic Evidence on
Community Hypertension Interventions. Am J Prev Med 2017;53:S121–30.
[4] Hunter DJ, Reddy KS. Noncommunicable diseases. N Engl J Med 2013;369:1336–
43.
[5] World Health Organization. Global Action Plan for the Prevention and Control of
Noncommunicable Diseases 2013-2020. WHO; 2013.
[6] Checkley W, Ghannem H, Irazola V, Kimaiyo S, Levitt NS, Miranda JJ, et al.
Management of NCD in low- and middle-income countries. Glob Heart 2014;9:431–43.
[7] Vedanthan R, Bernabe-Ortiz A, Herasme OI, Joshi R, Lopez-Jaramillo P, Thrift AG,
et al. Innovative Approaches to Hypertension Control in Low- and Middle-Income
Countries. Cardiol Clin 2017;35:99–115.
[8] Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, et al. Effects of Community-
Based Health Worker Interventions to Improve Chronic Disease Management and
Care Among Vulnerable Populations: A Systematic Review. Am J Public Health
2016;106:e3–28.
[9] Mishra SR, Neupane D, Preen D, Kallestrup P, Perry HB. Mitigation of non-
communicable diseases in developing countries with community health workers.
Global Health 2015;11:43.
[10] Khetan AK, Purushothaman R, Chami T, Hejjaji V, Madan Mohan SK, Josephson
RA, et al. The Effectiveness of Community Health Workers for CVD Prevention in
LMIC. Glob Heart 2017;12:233–43.e6.
[11] Svoronos T, Mjungu P, Dhadialla R, Luk R, Zue C, Jackson J, et al. CommCare:
Automated quality improvement to strengthen community-based health. Weston: D-
Tree International 2010.
[12] World Health Organization. WHO | HEARTS Technical Package 2019.
https://www.who.int/cardiovascular_diseases/hearts/en/ (accessed November 14,
2019).
[13] World Health Organization. Guideline for the pharmacological treatment of
hypertension in adults. Geneva: World Health Organization; 2021.
[14] Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, et al. 2020
International Society of Hypertension Global Hypertension Practice Guidelines.
Hypertension 2020;75:1334–57.
[15] Duffy S, Svenson J, Chavez A, Kelly M, Wise P. Empowering Community Health
Workers With Mobile Technology to Treat Diabetes. Ann Fam Med 2019;17:176.
[16] Duffy S, Norton D, Kelly M, Chavez A, Tun R, de Guzmán Ramírez MN, et al.
Using Community Health Workers and a Smartphone Application to Improve Diabetes
Control in Rural Guatemala. Global Health: Science and Practice 2020.
https://doi.org/10.9745/GHSP-D-20-00076.
3. Study Procedures and Interventions
Provide an overview of the types of records that will be reviewed, what information from
these records will be collected, and the kinds of analyses that will be performed on the
study data. If data from multiple sources will be used describe this here (e.g., medical
record information connected to imaging or billing information or data from multiple
institutions collated).
* Briefly describe the procedures and interventions that will be
performed for this project or study and all study arms involved. Do not
include information on recruitment or consent.


PRINTED ON: 6/14/2024
21 / 46
CHWs will meet with patients at enrollment visit and monthly thereafter. All study
data will be collected using the CommCare application running on Android
smartphones or tablets. 
At enrollment, information on basic demographic information, past medical history,
and current medications will be collected. CHWs will measure blood pressure, height
and weight. Patients will also be administered the Hypertension Self-Care Activity
Level Effects (H-Scale) questionnaire and the Patient Assessment of Chronic Illness
Care (PACIC) survey on their satisfaction with their current hypertension treatment.
They will be assessed for side effects of current medications and signs and
symptoms of possible complications of hypertension, including ischemic heart
disease, cerebrovascular disease, heart failure, and kidney disease. Blood will be
drawn by venipuncture or capillary sample to assess lipid profile, serum creatinine,
sodium, chloride, potassium, ALT and blood glucose. 
Based on information entered by the CHWs into the CommCare application designed
for this study, the application will provide recommendations (and underlying rationale
for these recommendations) for prescription of antihypertensives (amlodipine and/or
losartan OR enalapril) and medications to reduce cardiovascular risk (aspirin and
atorvastatin) if indicated, lifestyle modification, and referral to the supervising
physician (Dr. Tun) if indicated for potential complications of hypertension. 
CHWs will then provide these interventions assisted by recommendations from the
application. These procedures (aside from the enrollment panel of lab tests and
questionnaires described above) will repeat at monthly visits. 
CHWs will be able to contact Dr. Tun, Dr. Letona, or PI/PD Dr. Sean Duffy during the
visit as needed for advice on patient management. After each visit, clinical data will
be uploaded to CommCare’s secure server and reviewed within one week of the visit
by Dr. Duffy, Dr. Letona, and/or Dr. Tun, who will verify the current treatment plan
and contact the coordinators of the CHW program if any changes to treatment are
necessary, including the addition of other medications outside of the treatment
algorithms per their clinical judgement. In the case that changes are necessary,
CHWs will contact patients via phone or visit them at home to communicate and
carry out changes.
CHWs will provide continuous feedback on the application, as well as program
workflows and logistics. Based on this feedback, as well as monthly analysis of
patient data, we will revise application algorithms, workflows, and user interface.
This pragmatic design will allow for iterative application and program improvements,
leading to a refined product that we can then scale up and evaluate in a larger
controlled trial during the R33 phase of this NIH funded project. 
At the 6 month visit, the blood tests and questionnaires listed above will be
repeated and subjects will undergo semi-structured interviews to gain additional
insight into their experience with the program.
4. Incidental or Adventitious Findings
* Will any study procedures produce incidental or adventitious
findings (e.g., imaging scans, laboratory blood tests, depression
screening questionnaires, etc.)?
  
Yes 
No 


PRINTED ON: 6/14/2024
22 / 46
5. Instruments Involved
This question is intended to identify projects involving the development or use of
medical devices. This does not apply to surveys, questionnaires, or statistical analysis
software.
* Are there instruments of any kind, including software, tests run on
samples, and algorithms, used in the study?
  
Yes 
No
5.1. Health-Related Purpose
  * Are any instruments used for health-related purposes
including diagnosis or treatment?
  
Yes 
No 
5.2. Specific Medical Mobile Application
* Does this study involve a medical mobile application focused
on specific health related conditions and not just general
wellness activities?
  
Yes 
No 
5.3. Instrument Assessment
Please contact the FDA Regulated Research Oversight Program if you are
unsure whether your project involves assessing the safety and/or efficacy of an
instrument.
* Do any aims of the study involve assessing the safety
and/or effectiveness of those instruments? 
  
Yes 
No 
5.4. Data Submitted to FDA
* Will data from the proposed activity be submitted in an
application to the FDA?
  
Yes 
No 


PRINTED ON: 6/14/2024
23 / 46
Reporting Results
Studies with potential for discovery of incidental or adventitious findings
require special consent form language. Review the guidelines on consent
form language in HRP-503 Consent Form Template.
1. Originating Procedure
* Identify the procedure that could create the findings. (e.g., imaging
scan, laboratory blood test, depression screening questionnaire, etc.)
Laboratory tests may identify conditions previously unknown to subjects, such as
kidney disease, liver disease, or diabetes.
 
2. Results Released
* Will findings be released to subjects?
  
Yes 
No 
2.1. Type of Results
  * Describe which findings will be released to subjects, and
why. Explain what the subject (or their doctor, if applicable)
could do with this information.
All abnormal laboratory findings will be released to the patient as they could
be clinically important and may require alteration of current treatment plans.
The supervising physicians for this study will use laboratory results to guide
treatment related to the aims of the study (hypertension and cardiovascular
risk reduction) as well as to provide appropriate management and/or referral
to other physician(s) for management of abnormalities not related to the
specific aims.
 
2.2. Entity Assessing Release


PRINTED ON: 6/14/2024
24 / 46
The IRB would not expect (and in some cases will not allow) the dissemination
of information to subjects generated from tests or procedures that are
considered experimental.
  * Indicate who will assess whether the information should be
reported to subjects and the qualifications of those making such
assessments. If it is based on a score, address whether the
samples are run in a CLIA-certified laboratory.
The supervising physicians (Dr. Tun, Dr. Letona, and Dr. Duffy) for this study
will guide reporting of incidental findings. Dr. Tun is a general practitioner and
Dr. Duffy is a family physician and both are skilled in the evaluation of
common laboratory tests (such as those used in this study) and
management of abnormalities in these tests.
 
2.3. Reporting Timeframe
  * Provide the timeframe for reporting findings to subjects,
and if applicable, their physicians.
Within 1 month.
 
2.4. Reporting Process
* Describe the process for reporting results to subjects,
including who will disclose results and whether any additional
resources are in place. If results will be place in the subjects'
medical records, please indicate this.
One of the supervising physicians will review patient data, including
laboratory tests, on a monthly basis. Incidental findings/abnormal results will
be discussed with the community health workers, who will then relay this
information to subjects and any recommendations/instructions for treatment
or other follow-up. Subjects will be able to access treatment or further
work-up for abnormalities as needed at Hospital Obras Sociales Monseñor
Gregorio Schaffer in San Lucas Tolimán, Guatemala (where Dr. Tun is the
attending physician). Abnormal results will be noted in the patient's medical
record.
 


PRINTED ON: 6/14/2024
25 / 46
Subject Identification: Medical Records
1. Medical Record Use
* Will medical records be used to identify subjects or records?
  
Yes 
No
1.1. CRDS Usage
CRDS assists UW investigators with developing data queries and delivering data
from the UW Health Enterprise Data Warehouse (EDW) to be used in feasibility
assessments, recruitment of participants, pilot studies, and retrospective
analyses.
* Will you use the Clinical Research Data Service (CRDS) to
identify subjects via these records?
  
Yes 
No 
1.2. Record Identification Details
* Describe how eligible subjects will be identified using
medical records, including 1) which records will be accessed and
2) who will identify eligible subjects.
Patients with hypertension who may be eligible to participate in the study
will be identified by community health workers (CHWs) and other study
personnel (including PI Dr. Duffy and research assistant Taryn Valley) from
lists of such patients maintained by the community health worker program,
as well as from records stored in the secure CommCare database of patients
identified as having hypertension through the concurrent study of
hypertension diagnosis by CHWs, which is also funded by this grant.
 
Risks and Benefits
1. Direct Benefits Intended
For this type of research there are generally no direct benefits to subjects. The
response to this question, "There are no direct benefits to subjects", would be
acceptable.


PRINTED ON: 6/14/2024
26 / 46
* Are any of the research activities intended to directly benefit
subjects?
  
Yes 
No
1.1. Direct Benefit Details
* Describe how subjects will benefit from the research activity.
Controlling hypertension reduces the risk of stroke, coronary artery disease,
congestive heart failure, end-stage renal disease, peripheral vascular
disease, as well as overall mortality. Providing statins, +/- aspirin, for
hypertensive patients who are at high risk of heart attack and stroke or
have a history of these complications greatly reduces the risk of these
potentially fatal or life-altering events.
2. Potential Benefits to Society
Describe how the research might help future patients.
* Describe the importance of the knowledge reasonably to be gained
from this study and what benefit the research may provide to society.
If we can show that CHWs can effectively manage hypertension with remote
physician supervision, this would have important implications for global hypertension
control. Currently, less than 10% of patients with hypertension in low- and middle-
income countries (LMIC) have blood pressure at goal. If this is shown to be an
effective strategy, task sharing with CHWs and other frontline health workers could
help to improve treatment of hypertension in LMIC, which often lack sufficient
numbers of more highly trained health workers, such as physicians and nurse
practitioners, to address this important global health problem.
3. Direct Physical Intervention
A physical intervention refers to study procedures that may pose a risk (however
minimal) to a subject's body (e.g., blood draws, MRI scans, drug or device trials,
exercise, dietary restrictions/supplements). Examples of activities that are NOT physical
intervention include obtaining informed consent and administering surveys.
* Does this study involve direct physical intervention with subjects?
  
Yes 
No  


PRINTED ON: 6/14/2024
27 / 46
3.1. Physical Risks and Discomforts
* Describe the most common or frequent physical risks and
discomforts expected related to study participation (e.g.
pain, bruising, redness/itching).
Bruising is a common outcome from drawing blood (venipuncture). Blood
pressure measurement does cause mild arm discomfort.
 
3.2. Unusual Physical Interventions
* Does the protocol involve physical interventions that will
NOT be conducted in clinical settings (e.g., blood draws in a
medical clinic) or designated research areas (e.g., exercise
testing in an approved lab) where they would normally occur?
  
Yes 
No 
3.2.1. Outside Physical Interventions
* Describe the physical interventions performed
outside a clinical setting or designated research area.
Measurement of blood pressure and other vital signs; blood
draws.
 
3.2.2. Interventions Location
* Describe where the interventions will occur.
These interventions will primarily occur in clinical settings
(clinical sites in rural communities run by the network of
community health workers with which we are collaborating), but
may occur during home visits.
 


PRINTED ON: 6/14/2024
28 / 46
3.2.3. Emergency Plan
* Describe the plan for handling emergencies,
including who will provide medical oversight, if
applicable.
Emergencies resulting from these interventions are not
anticipated. Guatemalan co-investigator Dr. Tun, study team
physician Dr. Letona, and PI Dr. Duffy will be available to consult
with community health workers (CHWs) remotely as needed and
transport to the hospital in San Lucas Tolimán can be arranged
so that Dr. Tun or Dr. Letona can evaluate a patient in person as
needed. All CHWs are trained in basic emergency care.
 
4. Potential Psychosocial Risks
For this type of research the risks to subjects are generally limited to the risk of breach
of confidentiality. The response to this question, "There is a risk of breach of
confidentiality", would be acceptable.
* Describe any potential psychosocial risks to subjects, such as
psychological stress or confidentiality risks (including risk to
reputation, economic risks, and legal risks).
Since personal and medical information will be collected from subjects, there is a risk
of potential breach of privacy/confidentiality. 
If conducting activities in participants' homes, there's a risk associated in situations
of suspected abuse which involve mandatory reporting requirements and informing
subjects of this reporting requirement.
 
5. Procedures to Minimize Risks
The response to this question should address how the risk of breach of confidentiality
will be minimized. For example, it could be described that the study team has several
measures in place to protect against a breach of confidentiality, such as limiting the
number of people who view identifiable information, coding study instruments, storing
study data in restricted areas and on computers that are password-protected, only
transmitting coded data outside the institution (if data will be shared), and using a
secure web-interface to transmit data off-site (if data will be shared).


PRINTED ON: 6/14/2024
29 / 46
* Describe the procedures in place to minimize risks from all
interventions performed for research purposes. This should include
activities in place to identify, monitor, mitigate, and eliminate risks to
the degree possible.
Study interventions will be performed in a private room or, at a minimum, out of
earshot of other people in order to ensure privacy and confidentiality. Data will be
collected on encrypted, password protected smartphones or tablets using the
CommCare application, which is also password protected and encrypted. Study data
will be stored on CommCare's secure server, which is HIPAA compliant, secure
University of Wisconsin servers, and secure computers in Guatemala. Any hard
copies of data containing PHI will be stored in locking filing cabinets in controlled-
access facilities.
 
Subject Population
1. Total Subjects
You must provide an integer. If you are enrolling a range of subjects (e.g., 50 to 100
subjects), enter the larger number.
* Provide the number of subjects that will be enrolled at sites for
which UW Madison is serving as the reviewing IRB.
30
 
2. Inclusion Criteria
* Describe the main inclusion criteria.
Adults age 18 or greater with diagnosis of hypertension AND blood pressure (BP)
>=140/90 OR currently taking
antihypertensive medication.
 
3. Exclusion Criteria


PRINTED ON: 6/14/2024
30 / 46
* Describe the main exclusion criteria.
- Pregnancy
- Severe comorbid condition(s) with life expectancy less than 1 year
 
4. Targeted Populations
Populations could be racial/ethnic, sex, or gender (this also applies to gender identity, or
lack thereof).
* Will this study target or exclude specific populations?
  
Yes 
No
Special Populations Justification
1. Justification
If more than one special population is enrolled, separate justifications should be
provided for each unique population.
* What is the justification for the inclusion of these subjects?
Study recruitment and activities will occur in the municipality of San Lucas Tolimán,
Guatemala. A large majority of the population in this area belongs to the Kaqchikel
Maya ethnic group and speaks both Spanish and the Kaqchikel language. Average
income in these communities is less than $1000/year.
 
2. Safeguards
Include the measures that will be taken to minimize any potential coercion or undue
influence in recruitment and ongoing participation in the study.
* Describe the additional safeguards that have been included in this
study to protect the rights and welfare of these subjects.
Potential subjects will be assured that their participation will have no bearing on
services that they currently receive or may receive in the future from our local
partner, the San Lucas Mission. All consent materials will be translated into Spanish
and informed consent will be obtained by CHWs who are bilingual in Spanish and
Kaqchikel (which is not generally used as a written language).


PRINTED ON: 6/14/2024
31 / 46
 
Recruitment Methods
1. Recruitment Plan
This description should address what methods will be used, when and how often they
will be used, and how many times potential subjects will be contacted.
* Describe the recruitment plan for this study.
Subjects will be recruited by community health workers (CHWs) from patients
identified as having hypertension during the hypertension screening and diagnosis
study as well as from among patients previously known to have hypertension by the
CHWs.
 
2. Recruitment Material Upload
Upload recruitment materials such as recruitment emails, letters,
phone scripts, brochures, or advertisements.
There are no items to display
3. Approved Recruitment Database Usage
* Are you using an IRB approved recruitment database to
disseminate recruitment materials or to contact subjects?
  
Yes 
No
Subject Screening
1. Preliminary Eligibility Screen
* Will subjects undergo a preliminary screen to determine basic
eligibility?
  
Yes 
No


PRINTED ON: 6/14/2024
32 / 46
1.1. Screening Materials
* Upload a copy of the screening questionnaire.
 
 
Screening Questionnaire - Feasibility study.docx
1.2. Data Retention
If you are retaining screen data, the previously uploaded questionnaire/script
should address this and include authorization language for maintaining PHI if
HIPAA applies.
* Will you be retaining screen data from subjects who do not
enroll in the study?
  
Yes 
No 
2. Planned Study Procedures Before Obtaining Consent
Examples include fasting, discontinuing medications, etc.
* Will there be any procedures performed before informed consent is
obtained from subjects (apart from screening)?
  
Yes 
No
2.1. Procedure(s) Details
* Describe the applicable study procedures that will be
conducted before informed consent is obtained from subjects.
Potential subjects will be instructed to come to study screening/enrollment
fasting in case they do quality as baseline labs will be drawn, including
fasting lipid panel and fasting glucose. For patients who have been
diagnosed with hypertension, but are not currently taking medication, a
blood pressure will be checked to see if they qualify (BP >=140/90). For
women who are capable of conceiving (premenopausal, no history of tubal
ligation or hysterectomy) and who are not sure if they are currently
pregnant, a urine pregnancy test will be required prior to enrollment.


PRINTED ON: 6/14/2024
33 / 46
Remuneration and Costs
1. Payment
* Will subjects be compensated to participate in the study?
  
Yes 
No  
2. Costs
* Will subjects incur any costs as a result of study participation
(pharmacy preparation fees, payment for a device, billing of study
procedures to subjects insurance)?
  
Yes 
No  
Privacy and Confidentiality
1. Privacy Plan
Privacy is defined in terms of having control over the extent, timing, and circumstances
of sharing oneself (physically, behaviorally, or intellectually) with others. In the context
of research, this primarily pertains to methods used to obtain information about subjects
or the setting in which research takes place. 
* Explain how the subjects' privacy will be protected. (e.g., research
intervention is conducted in a private room).
Study interventions will be performed in a private room or, at a minimum, out of
earshot of other people in order to ensure privacy and confidentiality.
2. Level of Identifiability
* Select how subjects are identified in the data. Check all that apply.
Directly: Direct Identifiers stored on data (e.g., name, initials, phone number, SSN, or
medical record number, stored on data)
Coded or Indirect Identifiers: data includes a link to direct identifiers (e.g., name,
initials, phone number, SSN, or medical record number linked to data but stored
separately)


PRINTED ON: 6/14/2024
34 / 46
No Identifiers (De-identified, Anonymous, or Anonymized): stored data is stripped of all
identifiers
2.1. Necessity of Data
* Explain the necessity of collecting or maintaining data
linked to subjects’ identities.
Maintaining data linked to subject's identities is necessary for continuity
of medical care for patients enrolled in the study and technical support
of the mobile health application that will be used by the community
health workers.
 
2.2. Retaining Data
* How long will data linked to subjects’ identities be
retained?
Data containing subject identifiers will be retained on secure CommCare
servers and/or in Silo during the period of this grant (through September
2026) to allow for recruitment for other studies funded by the grant.
Data containing PHI may also be maintained long-term by the San Lucas
Mission for patient care purposes.
 
3. Data Protection Plan
Records and data include informed consent documents, case report forms or study flow
sheets, survey instruments, database or spreadsheet, screening logs or telephone
eligibility sheets, web based information gathering tool, audio/video/photo recordings of
subjects, labeled specimens, data about subjects, subject identifiers, etc.
The study team should describe how data confidentiality will be protected. Some
measures that are often used and acceptable to the IRB are: using codes so that no
direct subject identifiers are recorded on data collection sheets; creating codes for data
that are not based on subject identifiers (i.e., avoiding codes that include subject
initials or are based on birth dates); and destroying the link to the code as soon as
possible.
* How will the study team protect research records, data, and/or
specimens against inappropriate use or disclosure, or malicious or
accidental loss, or destruction? Include how and where the data and/or


PRINTED ON: 6/14/2024
35 / 46
specimens will be stored.
A service known as CommCare will be used to collect data. Whenever data is
transmitted between one of the servers CommCare uses and the Android application,
it is sent using HTTPS. Here are the standards incorporated:
● Encrypted server-client connections using HTTPS
● All access to the cloud infrastructure is protected behind a firewall and require
unique VPN access permissions
● Data is transferred through channels monitored by intrusion monitoring systems
● Encrypted at-rest database and encrypted database backups every night
● Security management meets ISO 27001, PCI-DSS, SOC1, SOC2, SOC3, and HIPAA
standards
The CommCare application used to collect data and provide clinical decision support
will run on encrypted Android smartphones or tablets. The CommCare mobile
application itself is password protected and data collected by the application is
encrypted (AES 256-Bit Symmetric Encryption, fully HIPAA compliant). These are
only connected to the internet when data is being uploaded via a WIFI connection.
As soon as data from the CommCare application is uploaded to the secure servers
(described above), it is erased from the device. When not being used for study
purposes, these devices will be stored in a locked cabinet in the CHW headquarters.
Study team members interacting with subjects and assisting with their follow-up
(Guatemalan study team members, Dr. Duffy, Taryn Valley) and assisting with
technical support (Alejandro Chavez) will have access to data with subject
identifiers through the CommCare platform. If data containing PHI needs to be
downloaded from CommCare to UW servers for these purposes, such data will be
transferred securely using the Globus platform to the secure and HIPAA compliant
Silo server provided by the UW Social Science Computing Cooperative (SSCC). All
other study members will have access only to coded or deidentified data.
Data used for analysis of study outcomes will be deidentified prior to being
downloaded from the secure server described above. Any data containing PHI that is
downloaded from the secure CommCare database for study purposes or to facilitate
appropriate referral of patients determined to need more urgent medical care (e.g.
due to significantly uncontrolled hypertension) will be stored on password protected
encrypted laptop computers that are stored in locked locations when not in use. Any
hard copies of study data containing PHI will be stored in locked filing cabinets at
CHW headquarters in Quixaya and/or San Lucas Mission Hospital.
Deidentified data used for outcome analysis will be retained on UW servers for at
least 7 years following study completion. Data containing subject identifiers will be
retained on secure CommCare servers and/or in Silo during the period of this grant
(through September 2026) to allow for recruitment for other studies funded by the
grant. Data containing PHI may also be maintained long-term by the San Lucas
Mission for patient care purposes.
Study team has discussed the use of CommCare with the SMPH HIPAA Privacy
Officer and has obtained an advanced plan for the service that includes full HIPAA
compliance and a BAA. CommCare does not sell data to advertisers or other third
parties, or transmit such data without express user consent.
4. Certificate of Confidentiality
If NIH, CDC, FDA, or other federal funding from an agency that automatically issues a


PRINTED ON: 6/14/2024
36 / 46
Certificate of Confidentiality as part of the terms of the award, answer “Yes”.
* Is there a Certificate of Confidentiality (CoC), or will one be
obtained, for this research?
  
Yes 
No   
Retention of Data and or Specimens
1. Future Research Plans
* Will data and/or specimens collected for this study be banked for
future research outside the scope of the current project?
  
Yes 
No 
Consent: General
1. Obtaining Consent/Assent
* Will you obtain consent or assent from some or all participants?
  
Yes 
No 
1.1. Signed Consent/Assent
* Will you obtain signed consent or assent from all
participants?
  
Yes 
No 
1.2. Altering Required Elements
* Are you proposing to alter required elements of consent or
assent (e.g. required information will not be disclosed, or the
research involves deception)?
  
Yes 
No 


PRINTED ON: 6/14/2024
37 / 46
1.3. No Consent/Assent
* Are there some participants from whom you will not
obtain consent or assent?
  
Yes 
No 
 
Consent Overview
1. Consent Process
* Describe the consent process, including when and where it will
occur and how the consent process will be conducted (e.g., face to
face, phone or video discussion) and how consent information will be
provided to participants (e.g., in person, mailed/emailed).
Consent will be obtained in a private location at the study site and out of earshot
from other patients. Study procedures, potential risks and benefits will be explained
to the patient by the community health worker (CHW) in Spanish and/or Kaqchikel
depending on the patient's preferred language. A copy of the study information and
consent form in Spanish (as patients are generally only literate in Spanish even if
they primarily speak Kaqchikel) will be provided to the patient. If the CHW obtaining
consent is unsure about the patient's ability to provide informed consent, the
physician involved in the study will assess the patient and make this determination.
2. Disadvantaged Participants Involved
* Will the study enroll participants who are non-English speaking,
illiterate/low-literacy, or have visual/hearing impairments?
  
Yes 
No
2.1. Plan to Ensure Participant Understanding
* Describe the steps that will be taken to ensure the potential
participant's understanding and who will determine that a
potential participant understands the information.
Study procedures, potential risks and benefits will be explained to the


PRINTED ON: 6/14/2024
38 / 46
patient by the CHW in Spanish and/or Kaqchikel depending on the patient's
preferred language. A copy of the study information and consent form in
Spanish (as patients are generally only literate in Spanish even if they
primarily speak Kaqchikel) will be provided to the patient. If the CHW
obtaining consent is unsure about the patient's ability to provide informed
consent, the physician involved in the study will assess the patient and
make this determination.
 
3. Qualification Affirmation
* Do you confirm that all study personnel responsible for obtaining
informed consent have the following qualifications: 1) are familiar with
the details of the study; 2) will ensure subjects are provided with
sufficient information to make an informed and voluntary decision
about study participation; 3) are familiar with UW-Madison policies
regarding informed consent?
  
Yes 
No 
Consent and Authorization Upload
1. Consent/Assent Documentation
• E.g., information sheet, consent form, assent form, translated consent documents.
• Please use IRBs informed consent templates to develop consent processes and
documents for non-exempt studies.
• For educational and social-behavioral studies, you can use the Consent Form Wizard.
The Wizard does not include HIPAA authorization language.
* Upload all consent authorization, and/or assent documents.
 
 
Consent Form - Feasibility study.docx
 
 ~
English version of long ICF
 
 
Spanish consent form - Feasibility study.docx
 
 
Spanish version of long ICF
Non-English Consent


PRINTED ON: 6/14/2024
39 / 46
1. Translation Details
* Identify how the consent form and other participant-facing
documents will be translated into the subjects' native language. Study
team member
2. Translator Qualifications
* Identify who translated the consent documents and other
participant-facing documents and describe their qualifications.
We are currently using the IRB-approved Spanish translation of the short consent
form. The long consent form was translated by study team members Taryn Valley
and Sean Duffy (PI). Both are fluent in Spanish and have extensive experience with
Guatemalan Spanish in particular. Dr. Duffy has been certified as a Spanish medical
interpreter in the past and is currently certified by UW Health to see Spanish-
speaking patients without an interpreter.
HIPAA
1. Identifiable Information
* Will the research involve identifiable health information for any
reason?
  
Yes 
No 
1.1. UW Madison Health Care Component or Madison VA
The HCC of the UW-Madison currently includes SMPH clinical departments;
School of Pharmacy (clinical units only); School of Nursing; University Health
Services (non-student records only); State Laboratory of Hygiene; and
Waisman Center (clinical units only). Ensure the PI or any study team members
are covered under HIPAA Privacy Rule regulations as part of their appointment.
* Are you or any member of the study team conducting the
study under an appointment that is within the UW-Madison
Health Care Component (HCC) and/or Affiliated Covered Entity
(ACE) or the Madison VA?
  
Yes 
No 


PRINTED ON: 6/14/2024
40 / 46
1.2. HIPAA Authorization
* Will HIPAA authorization for access to the PHI be obtained
for all or some subjects, or for only some uses?
Yes, always: HIPAA authorization will be obtained from all subjects
with signed documentation.
Yes, sometimes or without signed documentation: HIPAA authorization will
not be obtained from some subjects/uses or may be obtained without a
signature.
No: HIPAA authorization will not be obtained from any subjects.
1.3. External PHI Access
* Will you access or obtain fully identifiable health information
from a health care provider that is not UW or UW Health or the
Madison VA, such as Meriter or ACHC, without first obtaining
patient permission or authorization?
  
Yes 
No 
International Research
1. Countries Involved
* List the country(ies) in which study activities will occur.
Guatemala
 
2. Site Details
* List the specific sites (e.g., name of clinic, hospital, school) at
which study activities will occur in the countries listed above.
San Lucas Mission (SLM) Health Care Program, Municipality of San Lucas Tolimán.
 


PRINTED ON: 6/14/2024
41 / 46
3. Ethics Committee or IRB Approval(s)
* Do any of the international sites involved in this study have ethics
committee or IRB approval?
  
Yes 
No
3.1. Regulatory Oversight Details
Explain how regulatory oversight for human subjects research at
study sites will be provided.
While the San Lucas Mission does not have an affiliated formal ethics
committee or IRB, this study was reviewed and approved by the San Lucas
Medical Committee and San Lucas Medical Director Dr. Rafael Tun. In our
past collaborations with the San Lucas Mission, the UW IRB has served as
the IRB of record for individuals affiliated with the Mission who are involved
in the research.
 
4. Letters of Support or Approval(s)
Upload any letters of support or approval for this study from relevant
officials or collaborators at these sites. 
 
 
San Lucas Mission Letters of Support.pdf
5. Local Knowledge
Describe the study team's knowledge of the local culture, community,
laws, and regulations.
UWSMPH has a long-standing relationship with SLM. In particular, PI Sean Duffy has
collaborated with SLM medical director Dr. Rafael Tun and SLM-affiliated CHWs on
several research projects over the past 5 years and has developed a strong working
relationship with this team. Dr. Duffy has successfully completed another project
with this community and is well-known to the clinic and its director.
 


PRINTED ON: 6/14/2024
42 / 46
6. Location Justification
Describe why the particular location(s) has been selected to conduct
the research.
UWSMPH has a long-standing relationship with SLM. In particular, PI Sean Duffy has
collaborated with SLM medical director Dr. Rafael Tun and SLM-affiliated CHWs on
several research projects over the past 5 years and has developed a strong working
relationship with this team Foreign research is paramount for this proposal because
the NIH grant projects developing and/or evaluating mobile health interventions to
improve health outcomes in low- and middle-income countries. We propose the
development and evaluation of a mobile health clinical decision support application
for community health workers to allow them to diagnose hypertension in LMIC and
thus the use of a domestic research site would not be appropriate. SLM is a
particularly well-suited site for this study because of its well-developed CHW
program, which currently uses the CommCare mobile application to facilitate care for
diabetes and childhood malnutrition.
 
7. Potential Risks
Describe whether the cultural, economic, or political conditions of the
country or countries would alter the risk for participants compared to
the same research conducted within the U.S.
No alteration of risks.
 
8. Communication Considerations
The consent form should include the methods for communicating with researchers taking
into account means available to subjects at the study location(s).
Describe any special considerations for communicating with subjects
during the course of the study (e.g., access to a local
researcher/coordinator, access to telephone or other methods of
communication, etc.).
We will communicate with subjects directly and through CHWs in individual villages.
 
9. Consent Considerations


PRINTED ON: 6/14/2024
43 / 46
Describe any special cultural considerations for obtaining informed
consent (e.g., community consent, presence of elders, etc.).
None
 
Interviews, Focus Groups, Surveys,
Questionnaires
1. Tool Details
* Describe the interview tools, questionnaires, or surveys that will be
used. Click the add button to provide information about each tool to
be used.
View
   
Tool
Description
Spanish translation of the Patient Assessment of Care for
Chronic Diseases (PACIC). Highlighted items will be asked.
These were selected with input from community health workers
based on their relevance to the research setting.  
Tool
Standardized
Yes  
File name
PACIC Spanish
Tool Manner
In-person
Tool Manner
Other
At community health worker clinic sites or patient homes in
Guatemala 
 
Date
Modified
12/11/2022  
View
   
Tool
Description
Patient Assessment of Care for Chronic Conditions (PACIC).
Highlighted items will be asked. These were selected with input
from community health workers based on their relevance to the
research setting.  
Tool
Standardized
Yes  
File name
Patient Assessment of Care for Chronic Conditions_revisions
Dec 22.pdf
Tool Manner
In-person


PRINTED ON: 6/14/2024
44 / 46
Tool Manner
Other
At community health worker clinic sites or patient homes in
Guatemala  
Date
Modified
12/11/2022  
View
   
Tool
Description
Semi-structured interview guideline for interviews conducted at
the end of the study to elicit patient feedback about the
hypertension program.  
Tool
Standardized
No  
File name
Semi-structured interview questions.docx
Tool Manner
In-person
Tool Manner
Other
At community health worker clinic sites or patient homes in
Guatemala  
Date
Modified
5/31/2022  
View
   
Tool
Description
Hypertension—Self-care Activity Level Effects (H-SCALE) -
Spanish translation  
Tool
Standardized
Yes  
File name
Final H-SCALE Spanish w DASH-Q_FINAL.doc
Tool Manner
In-person
Tool Manner
Other
At community health worker clinic sites or patient homes in
Guatemala  
Date
Modified
5/31/2022  
View
   
Tool
Description
Hypertension - Self-care Activity Level Effects (H-SCALE)  
Tool
Standardized
Yes  
File name
H-SCALE English.pdf
Tool Manner
In-person
Tool Manner
Other
At community health worker clinic sites or patient homes in
Guatemala  
Date
Modified
5/31/2022  


PRINTED ON: 6/14/2024
45 / 46
2. Cognitive or Psychological Assessment
* Are any of the uploaded instruments used to assess cognitive or
psychological status or function?
  
Yes 
No
Interviews, Focus Groups, Surveys,
Questionnaires Cont.
1. Focus Group
* Will the study involve conducting focus groups?
  
Yes 
No
2. In-Home Visit
* Does the study involve in-home visits?
  
Yes 
No
Supplemental Information
1. Additional Documents
Provide any additional relevant documents (e.g., data sharing
agreements, letters of support, MOUs, site permission letters), if
applicable.
 
 
2022-0794_Ajcalon_27Jun2022.pdf
 
 
2022-0794_CastroChuta_27Jun2022.pdf
 
 
2022-0794_Macario_27Jun2022.pdf
 
 
2022-0794_Salazar_27Jun2022.pdf
 
 
IIA template


PRINTED ON: 6/14/2024
46 / 46
1.1. Describe Documents
Describe what additional documents were added in 1.
Signed IIAs (Independent Investigator Agreement) by San Lucas Mission
personnel; translated in Spanish (previously by Carol Pech). Please note: in the
December 2022 revision, additional IIAs have been uploaded along with the
addition of each external collaborator.
 
Final Page
1. Assurance
The information presented in this application is accurate;
If the application is being submitted on behalf of the Principal Investigator
(PI) rather than by the PI, the information presented was done so with
the PI's agreement; and
The specific aims and description of research (including subject
population, subject interventions, collaborators, performance sites, and
general scope of work) in this IRB application are consistent with those
described in the sources of support listed as providing financial and/or
material resources to conduct this study.
* Do you certify the above statements?
  
Yes 
No
2. Complete and Submit Application Instructions
To complete and submit this application to the IRB office, please follow the steps below:
1. Select Ready to Submit or Exit on this page to be directed to the application
workspace.
2. In the application workspace, click the Submit activity to send the application to
the IRB office. NOTE: The Submit activity is only available to certain study team
members.

SAP_001.pdf: 
Official Title: A feasibility study of a novel mHealth clinical decision support application to
enable community health workers to manage hypertension with remote physician supervision
NCT number: NCT05479097
Document description: Statistical analysis plan
Document date: 04/12/2022


A. COVER PAGE 
Project Title: mHealth to Enable Task Sharing for Hypertension Care in LMIC
Grant Number: 5R21TW011891-02
Project/Grant Period: 08/10/2021 - 05/31/2023
Reporting Period: 08/10/2021 - 05/31/2022
Requested Budget Period: 06/01/2022 - 05/31/2023
Report Term Frequency: Annual
Date Submitted: 04/12/2022
Program Director/Principal Investigator Information: 
SEAN MICHAEL DUFFY , BA MD MPH
Phone Number: 6083547930 
Email: sean.duffy@fammed.wisc.edu 
Recipient Organization: 
UNIVERSITY OF WISCONSIN-MADISON 
UNIVERSITY OF WISCONSIN MADISON 21 N PARK AVE, STE 
6301 
MADISON, WI 537151218 
DUNS: 161202122 
EIN: 1396006492A1 
RECIPIENT ID: 1R21TW011891-01 
Change of Contact PD/PI: NA 
Administrative Official: 
BRENDA EGAN 
21 N Park St, Suite 6401 
MADISON, WI 53715 
Phone number: 6082623822 
Email: baegan@rsp.wisc.edu 
Signing Official:
BRENDA EGAN 
21 N Park St, Suite 6401 
MADISON, WI 53715 
Phone number: 6082623822 
Email: baegan@rsp.wisc.edu 
Human Subjects: Yes 
HS Exempt: NA 
Exemption Number: 
Phase III Clinical Trial: NA 
Vertebrate Animals: No
hESC: No
Inventions/Patents: No 
RPPR
FINAL
RPPR
Page 1


4.3  Statistical  Design  and  Power 
As  this  aim  is  focused  on  determining  the  feasibility  of  CHW-led  hypertension  management, 
power  analyses  were  not  performed.  The  main  outcome  of  interest  for  this  aim  is  the  agreement 
of  CHWs  and  physicians  with  the  CDS  application’s  recommendation  for  antihypertensive 
medications.  Based  on  our  experience  with  a  similar  diabetes  program  and  published  results  of 
other  CHW  interventions,  we  have  set  an  agreement  threshold  of  90%.  In  order  to  account  for 
application  updates  during  the  early  stages  of  the  study,  agreement  will  be  assessed  in  the  last 
3  months  of  the  feasibility  study.  Agreement  will  be  summarized  as  the  raw  proportion  of  visits 
for  which  both  the  CHW  conducting  the  visit  and  the  physician  reviewing  post-visit  data  agreed 
with  the  antihypertensive  recommendations  provided  by  the  application.  As  a  secondary 
analysis,  we  will  also  calculate  agreement  individually  for  CHWs  and  the  supervising  physician 
to  examine  any  discrepancies.  
Other  continuous  outcomes  will  be  summarized  using  means  and  standard  deviations,  both  at 
baseline  and  6  months  after  enrollment.  Paired  measures  will  be  assessed  for  change  using 
mean  change  and  standard  deviation  of  change.  These  changes  will  be  assessed  statistically 
versus  a  null  hypothesis  of  no  change  using  paired  t-tests  or  Wilcoxon  signed-rank  tests  on  the 
paired  differences.  The  continuous  outcomes  include  systolic  and  diastolic  blood  pressure,  CDS 
application  usability  score, 65   patient  weight,  LDL,  HDL,  total  cholesterol,  triglycerides,  fasting 
glucose,  Hypertension  Self-care  Activity  Scale  (H-SCALE)  subscores, 66,83   Patient  Assessment  of 
Chronic  Illness  Care  (PACIC)  subscale  score  and  overall  score, 64   and  serum  creatinine. 
Outcomes  of  study  visit  duration  and  physician  review  and  care  coordination  time  will  be 
summarized  over  the  whole  length  of  the  study,  and  examined  for  trends  with  respect  to 
progression  of  the  study,  both  with  respect  to  calendar  time,  and  time  from  patient  enrollment. 
Other  dichotomous  outcomes  will  be  summarized  using  proportions;  time  of  assessment 
depends  upon  the  outcome.  For  outcomes  that  are  measured  at  baseline  and  6  months  after 
enrollment,  the  raw  proportions  will  be  reported  for  both  periods,  and  association  between  the 
outcome  and  the  two  periods  will  be  statistically  assessed  versus  a  null  hypothesis  of  no 
association  using  McNemar’s  test.  Outcomes  to  be  assessed  for  change  from  baseline  include 
systolic  blood  pressure  <=  140mmHg,  systolic  blood  pressure  <=  personalized  goal,  adherence 
to  self-care  activities  as  indicated  by  established  H-SCALE  cutoffs,  and  global  patient 
satisfaction  with  hypertension  care.  Outcomes  to  be  reported  over  the  last  3  months  of  the  trial 
include  agreement  of  CHWs  and  physicians  with  various  CDS  application  recommendations 
(atorvastatin  and  aspirin  prescription,  and  referral  recommendations).  Outcomes  to  be  reported 
throughout  the  whole  trial  include  visit  completion,  medication  adherence,  incorrect  CDS 
recommendations  and  application  errors  and  malfunctions,  complications  of  hypertension  or 
hypertension  treatment,  and  referral  recommended  by  CHWs  that  are  completed.  For  the 
outcomes  assessed  over  the  whole  trial,  or  in  the  last  three  months,  the  raw  proportions  and 
occurrence  counts  will  be  reported  for  these  periods.  Additionally,  instances  of  these  outcomes  / 
frequency  of  occurrence  will  also  be  examined  versus  calendar  time,  or  time  since  subject 
enrollment,  for  potential  trends.   Patient  retention  will  be  determined  by  proportion  of  original 
patents  that  participated  in  a  follow-up  visit  6  months  or  longer  from  their  initial  visit. 
Duffy, Sean Michael 
Statistical Design and Power
Human Subject Report (A feasibility study of a novel mHealth clinical decision support application
RPPR
Page 68