Continuing the Conversation: A Multi-site RCT Using Narrative Communication to Support Hypertension Self-Management Among African-American Veterans
Phase: NA
Conditions: Hypertension
Sponsor: VA Office of Research and Development

17-185 “Continuing the Conversation: A Multi-site RCT Using Narrative Communication  
to Support Hypertension Self-Management among African-American Veterans”
Funding Agency: HSR&D
Principal Investigator/Study Chair: Sarah Cutrona, MD MPH
February 10, 2022 / Version 7
 
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Abstract
Background: Compared to other racial and ethnic groups, non-Hispanic African Americans 
have  an  earlier  onset  and  higher  prevalence  of  hypertension  (HTN)  as  well  as  a 
disproportionately  higher  risk  of  complications,  leading  to  higher  rates  of  cardiovascular 
morbidity and mortality. In previous work, we used storytelling in African Americans outside the 
VA, yielding significant improvements in blood pressure.  We translated these findings to the 
VA, developing and testing video-recorded Veteran narratives which we showed to African-
American  Veterans.   We  demonstrated  significant  differences  in  intention  to change  HTN 
management behavior immediately after video viewing; however, effects on blood pressure 
were not sustained, and six-month outcomes revealed only modest benefit over control (p = 
0.06).  Our findings highlight the need for longitudinal support to sustain the storytelling effect. 
Our proposed study provides longitudinal support via text messages, incorporating content from 
the participant’s chosen peer narrative as a means of sustaining motivation and engagement in 
HTN self-management.
Innovativeness: Our study, “Continuing the Conversation,” is a novel integration of peer 
narrative communication into technology. While use of an informatics tools (texting) as a 
channel to support self-management is not novel per se, the extension of a narrative via 
longitudinal texting is an innovative mechanism for supporting and sustaining HTN self-
management behaviors. Our Specific aims include: 
Aim 1
 
 . Refine and Pilot the Continuing the Conversation (CTC) intervention
 
 .  Previously, we 
created video-recorded stories told by African-American Veterans with HTN, describing their 
self-management strategies. We will refine CTC by adapting content from these videos to create 
narrative-aligned texts and we will pilot CTC with 20 Veterans.
Aim 2
 
 . Test CTC by conducting a randomized controlled trial.
 
   CTC ‘begins the conversation’ by 
showing Veteran Story videos to participants, then inviting participants to select a preferred 
narrative. We then ‘continue the conversation,’ offering longitudinal support via 6 months of 
narrative-aligned text messages. Messages cover key HTN content, providing education, 
reminders and weekly assessments, and include quotations derived from the chosen narrative. 
Control participants receive weekly assessment texts addressing the same key HTN self-
management behaviors.
Aim 3
 
 . Evaluate CTC effectiveness, and mediating factors, and conduct a cost analysis
 
 .  We 
hypothesize that, for the CTC Intervention group as compared to the control: (H1) the difference 
in blood pressure from baseline to 6 months (primary outcome) will favor CTC intervention 
compared with the change in control. (H2): Self-efficacy and HTN management behaviors 
during 6-month follow-up will be greater for those in the CTC intervention group than control.
Methods: In a randomized controlled trial, 600 African-American Veterans with HTN will be 
recruited from 2 VA healthcare sites with known disparities in HTN control.  We will use within-
site randomization (CTC vs. Control).  Outcomes will include blood pressure, self-efficacy and 
HTN management behaviors.   Longitudinal texts are designed to bring the storyteller back into 
the Veteran’s everyday life, reminding and reinforcing as our Veterans engage in the numerous 
daily decisions that will impact their blood pressure and their lives. Incorporating peer content 
into text messages in this way is highly innovative and offers a promising approach to 
supporting our Veterans.
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List of Abbreviations
Provide a list of all abbreviations used in the protocol and their associated meanings.
PI/SC: Principal Investigator/Study Coordinator
HIPAA:  American Health Insurance Portability and Accountability Act
SAE:  Serious Adverse Event
LSI:  Local Site Investigator
HTN: Hypertension
RA: Research Assistant
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Contents
Protocol Title:...............................................................................................................................5
1.0
Study Personnel................................................................................................................5
2.0
Introduction.......................................................................................................................6
3.0
Objectives.........................................................................................................................7
4.0
Resources and Personnel.................................................................................................7
5.0
Study Procedures.............................................................................................................8
5.1 Study Design......................................................................................................................8
5.2 Recruitment Methods.......................................................................................................13
5.3 Informed Consent Procedures..........................................................................................14
5.4 Inclusion/Exclusion Criteria..............................................................................................14
5.5 Study Evaluations............................................................................................................14
5.6 Data Analysis...................................................................................................................16
5.7 Withdrawal of Subjects.....................................................................................................16
6.0
Reporting........................................................................................................................17
7.0
Privacy and Confidentiality..............................................................................................17
8.0
Communication Plan.......................................................................................................17
9.0
References....................................................................................................................18
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Protocol Title: “Continuing the Conversation: A Multi-site RCT Using Narrative 
Communication to Support Hypertension Self-Management among African-
American Veterans”
1.0
Study Personnel

Provide name, contact information, and affiliations/employee status for the 
following:
Principal Investigator/Study Chair: 

Sarah Cutrona, MD, 781-687-2861, sarah.cutrona@va.gov, 8/8ths VA Employee VA 
Bedford Healthcare System
Co-Investigators:

Barbara Bokhour, PhD, 781-687-2862, Barbara.bokhour@va.gov, 8/8ths VA Employee 
VA Bedford Healthcare System

Stephanie Shimada, PhD, 781-687-2208, stephanie.shimada@va.gov, 8/8ths VA 
Employee VA Bedford Healthcare System

Gemmae Fix, PhD, 781-687-3368, gemmae.fix@va.gov, 8/8ths VA Employee VA 
Bedford Healthcare System

Judith Long, MD, 215-823-5800 x5875, Judith.long@va.gov, 8/8ths VA Employee 
Corporal Michael J. Cresenz VAMC

Howard Gordon, MD, 312 569-7473, howard.gordon2@va.gov, 8/8ths VA Employee 
Jesse Brown VAMC

Charlene Pope, PhD, 843-789-6577, Charlene.pope@va.gov, 8/8ths VA Employee 
Charleston VAMC 

Bridget Smith, PhD, 708-202-8387 x24870, bridget.smith@va.gov, 8/8ths VA Employee, 
Hines VAMC

Kevin Stroupe, PhD, 708-202-8387 x23557, kevin.stroupe@va.gov, 8/8ths VA Employee 
Hines VAMC
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2.0
Introduction

Hypertension (HTN) and complications of hypertension are unusually common among 
African Americans, leading to higher rates of cardiovascular morbidity and mortality.  
According to the National Health and Nutrition Examination Survey 2011-2014, the 
prevalence of HTN was highest among non-Hispanic African-American/black adults 
(42% for men; 46% for women) compared to non-Hispanic whites (31% men/30% 
women), Hispanics (27%/32%) and Asians (29%/27%).1  Disparities in HTN control may 
derive from differential rates of diagnosis, treatment titration, and patient factors 
including medication adherence, lifestyle changes, self-monitoring, and engagement with 
the healthcare system.  African-American patients routinely report lower trust in the 
healthcare system,2 which may limit their willingness to adhere to doctor-recommended 
treatments3. Effective HTN control through lifestyle change and medication adherence 
entails numerous small, repeated decisions.  Peer interventions can help to counter 
cognitive resistance which arises when patients have concerns about treatments or 
about medical information.  Narratives are a widely accepted and effective way to 
engage listeners and reduce cognitive resistance.4-8 Narrative communication 
(storytelling) has been defined as “any representation of a sequence of connected 
events and characters that has an identifiable structure, is bounded in space and time, 
and contains implicit or explicit messages about the topic addressed.”9  The 
effectiveness of narrative communication in changing attitudes and behavior follows from 
transportation and personal identification.10  Findings from our previous studies support 
the hypothesis that Veteran peer narratives will have a greater and more sustained 
impact if followed by longitudinal communications that ‘continue the conversation’.  This 
project addresses a key issue – HTN control in African Americans.  We believe it is 
important to pursue both traditional and novel dissemination strategies to share lessons 
learned. If we find the intervention to be successful, we will create implementation 
facilitation tools including an Integrated CTC intervention guide (hyperlinks to storyteller 
videos, electronic downloadable copies of Veteran-facing materials including Storyteller 
Selection cards, orientation brochures for the texting system, training guides for staff).  
We will work with OCC to create an Electronic Health Record-based referral tool to 
encourage teams to enroll patients in CTC and will explore mechanisms by which 
Veterans can initiate enrollment requests. We will disseminate findings from our work at 
health behavior change venues, including the Society of Behavioral Medicine, as well as 
at health informatics venues such as American Medical Informatics Association Annual 
Meeting.  As this work will ultimately be most effective if it is taken up by clinical 
practitioners and by the Veterans themselves, we will also seek to reach clinical 
audiences including those at Society for General Internal Medicine and will work with our 
Veteran Advisors as well as with our local and national Veteran’s Engagement 
Workgroups to disseminate information on the CTC intervention through channels 
accessible to and frequented by Veterans.  

Our intervention is intended for African-American Veterans, and we will intentionally 
oversample women Veterans with the goal of including in the sample 20% women (60 
women at each site, 120 total).  Children and prisoners will not be included in this study, 
as those under the age of 18 are not qualified and it is not feasible to include prisoners in 
the study. 
3.0
Objectives
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Our Specific Aims include:
Aim 1. Refine and pilot the Continuing the Conversation (CTC) intervention.  

1a. With input from Veteran Advisors, we will refine our CTC intervention, adapting 
content from our previously developed online videos (stories told by African-
American Veterans who have controlled their hypertension) to create narrative-
aligned text messages (‘storyteller texts’).

1b. We will pilot the process of providing guidance to 20 Veterans as they (a) View 
Veteran videos; (b) Select a preferred video narrative; (c) Sign up to Get texts 
through HealtheDialog Texting system.  
Aim 2.  Test CTC by conducting a randomized controlled trial with the following 
characteristics:

Setting and Sample
 
 : 600 African-American Veterans with hypertension. Veterans 
will be recruited from two VA healthcare sites with known disparities in 
hypertension control.

Design
 
 : Veteran-level randomization, stratified by site and within-site stratification 
by gender

CTC Intervention
 
 : An integrated peer narrative-based intervention (VIEW > 
SELECT > GET), beginning with VIEWing of VA Stories narratives, followed by 
SELECT a favorite Veteran Storyteller, and then GET favorite Storyteller “narrative-
aligned” text messages over 6 months

Control
 
 : 6-month HTN management assessment text messages without narrative 
component
Aim 3. Evaluate CTC effectiveness, and mediating factors, and conduct a cost 
analysis.

We hypothesize that, for those in the CTC Intervention group as compared to the 
control:

Hypothesis 1
 
 : The difference in blood pressure from baseline to 6 months (primary 
outcome) will favor CTC intervention group by 5mm Hg, compared with the change 
in control.  

Hypothesis 2
 
 :  Self-efficacy and hypertension management behaviors during 6-
month  follow-up  will  be  greater  for  those  in  the  CTC  intervention  group  than 
comparison.

We hypothesize that (H3) the effect of CTC on blood pressure will be mediated by 
the proximal measures of (H3a) cognitive and emotional processes (i.e.: emotional 
engagement with stories, self-efficacy) and (H3b) hypertension self-management 
behaviors.  We will further measure the marginal cost of this intervention. 
4.0
Resources and Personnel

Led by Principal Investigator and Co-Investigators at the Bedford VA, two sites will be 
recruiting patients for this study under the supervision of LSI’s at each site:  Corporal 
Michael J. Crescenz VA in Philadelphia, under the supervision of Judith Long, MD and 
Jesse Brown VA in Chicago, under the supervision of Howard Gordon, MD. 

Dr. Cutrona will be Principal Investigator on the study. Dr. Cutrona will oversee and 
coordinate activities carried out by the Text Content Development Team (Drs. 
Bokhour, Fix, Pope, Veteran Advisors), the Texting Protocol Development & 
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Implementation Team (Dr. Shimada, Veteran Advisors) and the Pilot/Trial Team (Drs. 
Long, Gordon, Veteran Advisors).  The Content Team will adapt content for text 
messages from existing video and interview transcripts.  The Protocol Team will adapt 
existing HealtheDialog texting protocols for use in the CTC intervention, will create 
brochures for Veterans with information about the texting system and will also develop 
guides for RAs (how to enroll Veterans in text system). Drs. Long and Gordon will 
oversee the pilot intervention at their respective facilities and the trial in subsequent 
years.  Veteran Advisors will provide focused input on content and acceptability of text 
messages and laminated video selection cards; timing and enrollment procedures for 
texting protocol; and acceptability of recruitment material.  Advisors, including Dr. 
Timothy Hogan, Director of the eHealth Partnered Initiative at the Center for Healthcare 
Organization and Implementation Research (CHOIR), Drs. Jeroan Allison, and Thomas 
Houston will be consulted regularly, providing content area expertise and input as 
needed on intervention development and implementation. Dr. Smith  will lead the 
analytic plan and cost analysis for the project, Dr. Stroupe will contribute to the cost 
analysis for this project.  Zhiping Huo will assist with data management under the 
direction of Drs. Smith and Stroupe. 
5.0
Study Procedures
5.1 Study Design

Design for Aim 1: Refine and Pilot
 
 : We will begin by refining and piloting the Continuing 
the Conversation (CTC) intervention with 20 Veterans.  We will adapt content from our 
previously developed online videos (stories told by African American Veterans who 
have controlled their hypertension) to create narrative-aligned text messages 
(‘storyteller texts’).  Interviewees have already provided consent to use content from 
their interviews beyond the previous study. Transcripts from previous interviews will be 
used to inform content for these text messages.  

We will pilot the process of providing over-the-phone guidance to Veterans as they (a) 
View the Veteran videos; (b) Select a preferred video narrative; and (c) Sign up to Get 
texts through the HealtheDialog Texting system.  The pilot will contain usability testing 
and a formative evaluation of the Veterans’ experiences. We will purposefully sample 
10 Veterans from each site (total of 20) and will aim to include 4 women Veterans (2 
per site).  We will pilot the process of (1) guiding the Veteran in at-home BP check, (2) 
selection of a preferred veteran storyteller after viewing all stories; (3) using this choice 
to inform selection of a texting protocol; (4) Receipt of 1 month of texts; and (5) follow-
up assessment at the end of 1 month.  We will assess feasibility of two options for 
Veterans to access texts: (a) via regular texting, available on all text-enabled phones; 
(b) via HealtheDialog ‘App’ which allows study team tracking of text opening (but is 
available only on Smart phones).  We will assess completion rates (how many 
Veterans have difficulty or discontinue texts early, reasons why) and perceptions (e.g. 
"I felt connected to the storyteller while receiving texts", "the number of texts was: too 
few, just right, too many”).  The formative evaluation will include a qualitative interview 
with all Veteran participants to understand their experiences with the CTC protocol. 
Our semi-structured interviews will cover their overall experiences, as well as specific 
questions about the enrollment process, frequency and content of messages. RA’s will 
take brief, descriptive field notes.  
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
We will then Test CTC by conducting a randomized controlled trial with the following 
characteristics:

Setting and Sample
 
 : 600 African-American Veterans with hypertension. Veterans will 
be recruited from two VA healthcare sites with known disparities in hypertension 
control.

Design
 
 : Within-site randomization of Veterans

CTC Intervention
 
 : An integrated peer narrative-based intervention (VIEW > SELECT > 
GET), aligned with the process of providing over-the-phone guidance to Veterans as 
they (a) View the Veteran videos; (b) Select a preferred video narrative; and (c) Sign 
up to Get 6-months of narrative, educational and assessment texts through the 
HealtheDialog Texting system.  We will be guiding the Veteran in (1) at-home BP 
check, (2) selection of a preferred veteran storyteller after viewing all stories; (3) using 
this choice to inform selection of a texting protocol; (4) Receipt of 1 month of texts; and 
(5) follow-up assessment at the end of 6 months. 

Control
 
 : 6-month VA HTN texting protocol without narrative component

Blood pressure will be checked with guidance from the RA over-the phone using an at 
home BP monitor at baseline and at a 6-month follow up for both arms.
HealtheDialog Texting system, Sending and Receiving Texts

The Office of Connected Care (OCC), with whom we have partnered, has invested in 
HealtheDialog, an automated text messaging system recently developed and field-tested 
in five VA facilities.  Text messages are automatically sent from the pre-programmed 
automated VA text messaging system to users.  Veteran participants will receive text 
messages delivered using this VA HealtheDialog texting system.  

Protocols for text messaging will be developed in year 1 based on existing hypertension 
protocols (for further details see ‘CTC Texting Protocol’ below and Appendices 3-6). 
Details are provided below; briefly, for the intervention group, weekly texts will include up 
to 3 narrative-aligned texts (messages that reinforce the voice and themes brought up in 
videos regarding HTN self-management, ‘e.g. Danny says: ‘I try to take my med at the 
same time every morning’) and 1 assessment text (e.g. ‘On how many of the past 7 days 
did you take your BP pills at the same time every day? Text 1 thru 7).  Intermittently, a 
week will include no narrative texts and up to 4 assessment texts.  Control participants 
will receive 1 assessment text weekly.  For assessment texts, users send a keyword 
response based on the instructions in the previous message, e.g., “Did you take your 
medications  today?  Reply:  MED  Yes  or  MED  No.”  Depending  on  if  the  patient 
responded “MED Yes or MED No,” HealtheDialog automatically sends a programmed 
response (e.g., “Great work!”). Incoming and outgoing messages activity logs can be 
viewed and recorded through the system dashboard.
Time and Days of Text Delivery

While the protocols allow time of day to be adjusted for each participant, leadership of 
the HealtheDialog system do not currently recommend this approach due to the level of 
complication  and  resulting  burden  that  it  adds  to  the  automated  system.   Such 
modifications will also increase the time required for enrollment since (in the system as 
currently configured) the person signing up the patient (the RA) must go in and manually 
change each message’s delivery time.  We recognize that for a longitudinal texting 
support program to be most useful to our Veterans, it would be optimal to have some 
ability to customize timing.  In our year 1 development phase, we will work closely with 
the Office of Connected Care to identify options to allow flexibility on timing, and during 
our pilot phase we will aim to explore feasibility of customizing timing at enrollment by 
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assigning messages to be sent at a few different times and obtain feedback during our 
pilot follow-up specifically regarding participant thoughts on times texts were received.
Videos, Procedures surrounding Video viewing and Selection of text protocol: Our 
team has already created and tested video-recordings available online (Appendix 1) in 
which African-American Veterans with controlled HTN share their stories (describing 
challenges and successes managing their HTN).   

Procedure for Intervention group participants
 
 .
VIEW videos: During the over the phone visit, the Research Assistant (RA) will ensure 
the participant has a quiet space and online access to the 5 Veteran narratives so that 
participants can view the 5 brief videos.  We will send the link to the videos to the 
participant if they have given permission to contact via email, otherwise we will send 
them the link via text, or read it aloud to them.  Veterans will not be provided DVDs but 
since they will be provided with the web address they can access the videos on their 
own if they wish to re-view videos. If the Veteran requests use of a virtual platform to 
watch the videos, such as WebEx, Zoom, or other approved platform, the RA will create 
a session and utilize the shared screen to watch the videos only.  No PHI or PII will be 
shared during this time.
SELECT a Preferred Veteran Storyteller: After the Veteran has viewed the videos, the 
Veteran will complete the final brief section of the survey. If necessary the RA will re-
contact via phone or by text at that time to ask survey questions. The RA will remind 
participant of the five storytellers they just watched.  If at that time the Veterans wish to 
pause and go back to see any videos they missed or re-view any videos, they may. The 
RA will explain that this selection will inform the content of the text messages sent to the 
Veteran over the upcoming 6 months, with the goal of providing text messages that work 
well for the Veteran. The RA will explain that some messages will include either (a) 
direct quotes from this storyteller, referencing back to or building further upon the video-
recorded story; or (b) references to topics related to those which the Veteran talked 
about. If participant is not reached following watching the storyteller videos, the 
site coordinators will initiate a text requesting that they select a storyteller.  If they 
do  not  reply  to  the  text  request  and  are  still  unreachable  2-weeks  after  the 
baseline  visit  occurs,  we  will  select  a  storyteller  for  them  by  selecting,  in 
order,from a list of the 5 storytellers; when all 5 have been assigned in this way, 
we will start back at the top of the list. Lists will be maintained separately at the 
two sites. Participants will be told during the baseline visit, once assigned to 
intervention, after watching the videos that if they do not select a storyteller for 
some reason, they will be assigned one by the research team.
GET preference-based, narrative-aligned CTC texts: Veteran participants will receive 
text messages, with messages chosen to align with their selected storyteller. These texts 
will be delivered using the VA HealtheDialog texting system, described above. In the 
baseline phone visit, Veterans will receive an orientation to the texting system, over the 
phone. RAs will enroll Veterans in HealtheDialog and provide education on use of the 
system and what to expect from the CTC protocol.

Procedure for Control Group Participants
 
 : 
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Veterans will have an over-the-phone visit during which the RA enrolls each Veteran in 
the control texting protocol and collects baseline data including blood pressure and all 
Baseline elements described in Section 5.5. Veterans will then receive 6 months of text 
messages, receiving one assessment text weekly with a follow-up reminder if needed, 
and they will also receive responses to their reply to assessment texts.
CTC Texting Protocol (content and tasks required from participant): 

Narrative-aligned Texts (“Storyteller Texts”): Participants will be invited to choose the 
Veteran storyteller whom they found most compelling; this choice will then be used to 
guide selection of a longitudinal texting protocol designed to ‘continue the conversation’ 
over a six-month period. Storyteller texts are intended as cues, triggering recollection of 
the foundation laid through the initial story viewing. Our intention is to use these texts to 
engage participants on both an emotional and cognitive level. We will adapt transcribed 
content from our VA Stories videos to create narrative-aligned texts (“storyteller texts”) 
(Appendix 3). Adaptation of transcribed content will be conducted with 3 goals: to identify 
quotations for which (1) the clarity and length are conducive to incorporation into a 
stand-alone text message, (2) content maps to our conceptual model and (3) to ensure 
that quotations convey the storyteller’s ‘voice’ (their own words/phrases). Where direct 
quotations conducive to incorporation into text are not available, narrative-aligned texts 
will convey messages that reference and build upon the story content.

Our team has already completed qualitative analyses of full (unedited) video recordings 
of  Veteran  narrators.  Completed  analyses  identified  story  segments  guided  by 
storytelling best practices and informed by constructs from our conceptual model; this 
work will inform our selection of content for storyteller texts.

In year 1, we will create HealtheDialog texting protocols corresponding to each of the 
video-recorded Veteran storytellers. To create the CTC texting protocol (Appendix 4), we 
will adapt existing texting protocols. We will include core content via the longitudinal 
texting protocols that is consistent across texting protocol options. Key concepts (such 
as talking with your doctor, taking your medications, avoiding salt and physical activity) 
will be delivered to all participants, with messages customized to reflect the voice of the 
selected storyteller as detailed above.

To  create  these  protocols,  we  will  adapt  content  from  unedited  videos  to  create 
narrative-aligned  text  messages  (‘Storyteller  texts’).  In  our  original  storytelling 
intervention,  we  used  EHR  data  to  identify  African-American  Veterans  who  had 
successfully controlled their HTN. From this group, potential Storytellers participated in 
screening interviews and were selected based on ability to tell engaging, authentic 
stories about HTN management behaviors. For each selected storyteller, the research 
team  facilitated  an  hour-long,  videotaped  “story”  in  which  the  Veteran  described 
successfully controlling his/her HTN. These stories were qualitatively coded to identify 
potential video content. Next, potential content was systematically ranked by Veteran 
and research team members. This process culminated in short videos by the 5 “best” 
storytellers. In our prior study, we obtained approvals from each participant to use 
content of the videos and transcripts in education and research materials beyond the last 
Stories project period. We obtained all appropriate waivers and permissions for further 
use of recorded audio  and videos; these remain  available  as outlined  in the Data 
Inventory Tool, on file with the Information Security Office in Bedford.
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
We will also create an assessment protocol which will send assessment texts to the 
Veteran once a week (for example, asking if they have missed any HTN medications in 
the past week, YES/NO response). 

To validate proper programming of the protocols into the system, we will enroll CPRS 
test patients as ‘participants’ to receive texts and ensure the correct texts are delivered 
at the correct times.

Intervention participants will receive up to sixteen text messages weekly for the duration 
of the 6-month study. Themes will address our HTN management behaviors and will 
also  include  general motivational  statements. Included  in  the protocol will be  texts 
designed to elicit a Veteran response to a question assessing status of a specific HTN 
self-management  activity.  These  assessment  texts  will  be  adapted  from  existing 
HealtheDialog texting protocols and from the H-SCALE (Hypertension Self-Care Activity 
Level Effects), a set of 31 measures including point prevalence measures (in the past 
seven days) for low-salt diet and physical activity. Weekly texts will include up to 3 
narrative-aligned texts (‘e.g. Danny says: ‘I try to take my med at the same time every 
morning’) and 1 assessment text (e.g. ‘On how many of the past 7 days did you take 
your BP pills at the same time every day? Text 1 thru 7), with a follow-up reminder text if 
needed. In addition, participants will receive responses to their assessment texts replies. 
Intermittently, a week will include no narrative texts and up to 4 assessment texts with 
responses.   
Phone number changes

During  enrollment  into  HealtheDialog,  an  action  that  will  be  done  over-the-phone 
together with the RA, a pop-up screen will prompt RA to remind Veterans to tell our 
study team if their phone number changes.  If this happened, we would update the 
number in the system. The HealtheDialog texting system dashboard does not collect a 
read receipt, but it would show if a patient doesn’t send a response message back.

Following best practice, baseline differences between intervention and comparison 
groups will be based on standardized differences, not simply tests of statistical 
significance.   All primary hypotheses will be tested by intent-to-treat; secondary 
analyses will account for important covariate imbalances between groups, levels of 
adherence to the intervention protocol, and missing data. All analyses will be two-sided, 
with alpha error = 0.05.

Our randomized controlled trial will be conducted at two sites.    

The study population will consist of African-American Veterans, both male and female, 
with diagnosis of HTN.  We anticipate recruitment of 600 African-American Veterans for 
this study. 

Minimizing Risk: Every effort will be made to make study participants comfortable when 
completing questionnaires or watching the video, and we will clearly communicate 
expectations regarding frequency of text messages at the time of study enrollment to 
avoid inconveniences.  We will also provide standard safety advice for text message use 
(e.g. avoid reading texts while driving or walking).
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5.2 Recruitment Methods

For the pilot, we will purposefully sample 10 Veterans from each site (total of 20) and will 
aim to include 4 women Veterans (2 per site).  

For the main RCT, We will recruit 600 African-American Veterans with HTN. Veterans 
will be recruited from  two geographically distinct VAMCs (Chicago and Philadelphia, 
Table 7) with a high proportion of African-American patients and known disparities in 
HTN control.
o
Jesse Brown VAMC
 
  in Chicago is a 189-bed hospital and teaching affiliate of 
the  University  of  Illinois-Chicago  and  Northwestern  University.   The  Jesse 
Brown  VAMC  and  its  four  affiliated  community-based  outpatient  clinics 
(CBOCs) in Chicago, Southern Cook County, and northwest Indiana provide 
primary care to roughly 30,000 veterans and 80% are African-American. Among 
primary care patients, approximately 18,000 have HTN. 
o
Corporal Michael J Crescenz (CMJC) 
 
 VAMC in Philadelphia serves over 90,000 
Veterans, operating CBOCs in Fort Dix, NJ, Gloucester County, NJ, Horsham, 
PA, and Center City Philadelphia. 

Using VISTA data, we will review data for potentially eligible patients for up to 2 years 
preceding recruitment. We will identify patients with a listed diagnosis of HTN (ICD10 
diagnosis codes: I10, I11.0, I11.9, I12.0, I12.9, I13.0, I13.10, I13.11, I13.2, I15.0, I15.1, 
I15.2, I15.8 I15.9, I16.0, I16.1, I16.9, N26.2) (further details on inclusion criteria listed 
below).  The final generated list of potential participants will be kept in a computer file 
that is password protected and only accessible by the RA and project staff.  Any printed 
list used by the RA in the clinic will be stored in a locked file cabinet when not in use. 
Staff will make all attempts to print the recruitment letters and labels, and stuffing the 
envelopes at the VA location, however if a location other than the VA is necessary for 
this task, all security requirements will be in place for transporting any study materials to 
the secondary work location of the RA’s home; ie. a signed Authorization to Transport, 
and RA will use a locked safe to store printed materials containing PII.    We will include 
both women and men in the study.  

Each potentially eligible Veteran will be sent a letter inviting participation, with an opt-out 
card. If no opt-out card is received in a two-week period, the RA will contact the Veteran 
by telephone, explain the study and ask several eligibility screening questions including 
the patient’s race/ethnicity and access to a cell phone with texting capability. 
Competency will be assessed during the phone screen questionnaire which includes 
cognitive functioning questions. 

If the Veteran is eligible and wishes to participate, the RA will schedule a time for the 
Veteran to  hold the visit over-the-phone.

At the start of the over-the-phone study visit and at the start of the follow-up phone visit 
(for both pilot and RCT) the RA will confirm the Veteran’s identity and confirm the 
address at which he or she will be located for the duration of the phone call.  This will 
provide RAs the ability to notify emergency personnel in the event that an emergency 
response is needed for any reason.

Intervention and control Veteran participants will both receive the same incentives.  Each 
participant will receive a $30.00 incentive per phone visit, for a total of two visits (in-
person baseline visit and follow-up data collection visit). Payment method may vary by 
site and will be based on what is available and most convenient for the Veterans. 
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Participant may incur costs related to receiving or sending texts if they do not have an 
unlimited texting plan; they will be notified of this in our consent form. 
Potential  risk  to  participants  when  receiving/responding  to  texts  while 
walking/driving etc.

During enrollment of participants, RA’s will review texting safety measures including 
avoidance of texting and driving (we will review available ‘do not disturb’ phone features 
with Veteran as desired), avoidance of texting while walking (or doing other mobile 
activity that requires visual attention); ensuring physical safety before pausing to review 
or respond to texts.
5.3 Informed Consent Procedures

We will be obtaining a waiver of informed consent documentation for all study activities.  
We will be requesting a HIPAA Waiver to obtain the participant list from which to recruit. 
For over-the-phone visits we are submitting a waiver of documentation of informed 
consent. 

We will train site RA’s at both sites in procedures to follow for baseline and follow-up 
visits.  Screening for eligibility and competency will be conducted during the phone 
screen questionnaire which includes cognitive functioning questions.  If the participant is 
eligible, able to complete the competency questions and is willing to participate, a 
baseline visit will be scheduled over-the-phone.  

The Bedford project manager will hold weekly training sessions including using Teams 
when needed to review and train RA’s at local sites in obtaining informed consent and 
conducting visits. 
5.4 Inclusion/Exclusion Criteria

We will include Veterans who have been receiving care at the recruiting VA site 
for ≥1 year prior to recruitment, with 2 or more visits documented over the past 
year.  We will include Veterans who have documented HTN (ICD10 diagnosis 
codes: I10, I11.0, I11.9, I12.0, I12.9, I13.0, I13.10, I13.11, I13.2, I15.0, I15.1, 
I15.2, I15.8 I15.9, I16.0, I16.1 I16.9, N26.2) during this 1-year period. We will 
include only patients who self-identify as African American or Black. In addition, 
participants must be on at least one medication for BP.  Eligible participants will 
need to have access to their own or a family member’s cell phone or smart 
phone for participation and they must be willing to use this phone for receipt of 
text messages over a 6-month period. Eligible participants will also need to have 
access to internet and a reliable device in order to watch videos.  If Veterans do 
not have a BP monitor at home, we will arrange to have one sent to their home – 
they must be willing to take their own BP or have someone assist them in doing 
so.  We will exclude Veterans who participated in our previous VA Stories study. 
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In addition, any Veteran who fails the memory and concentration questions 
asked in the screening survey will be excluded. Because hypertension 
management guidelines for pregnant females differ, pregnant women will be 
excluded; we have included this in the screening survey. 
5.5 Study Evaluations

We will pilot the process of (1) guiding the Veteran in at-home BP check; (2) 
selection of a preferred veteran storyteller after viewing all stories; (3) using this 
choice to inform selection of a texting protocol; (4) Receipt of 1 month of texts; and 
5) follow-up assessment at the end of 1 month.  Research assistants will collect 
field notes on items (1) (2) and (3).  For item (4) we will collect data on 
implementation/process measures throughout the 4-week period (see Table 8 
below, item 7 for details of these measures).  We will also assess feasibility of two 
options for Veterans to access texts: (a) via regular texting, available on all text-
enabled phones; (b) via HealtheDialog ‘App’ which allows study team tracking of 
text opening (but is available only on Smart phones). 

All data will be stored in accordance with VA policy. 

Only the study team and the PI will have access to this information. 
For the randomized controlled trial, as listed in the table below, we will collect 7 data 
elements: (1) Veteran characteristics; (2) Intervention dose/exposure; (3) Narrative 
Communication measures; (4) Social Cognitive-Theory-based measures; (5) 
Hypertension management behaviors; (6) Blood Pressure (BP) (blood pressure will be 
checked by participant through home BP monitor at baseline and at 6 month follow up); 
and (7) Implementation Data including Process Measures and measures of Fidelity.  
We will gather these elements through initial data collection (CDW), over-the-phone 
screening survey, baseline visit and follow-up visit observations and surveys, texting 
system and phone calls to participant.   
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5.6 
Data 
Analysis
With our recruited sample of 600 (and assuming follow-up rates, over-time within-person 
correlation, and BP standard deviations from our prior work (85% follow-up, correlation = 0.5, 
SD = 18 (equivalent to variance of 324)), we have over 80% power (alpha 0.05) to detect a 
difference of 5mm Hg.  In fact, we calculated power for a range of scenarios, and are able to 
maintain the 5mm Hg detection with a lower follow-up rate of 82%.  
Power for H2 & H3:  Conceptually, the CTC intervention impact on blood pressure is 
possible because the intervention will have an effect on more proximal cognitive and 
behavioral outcomes (H2) that then mediate the main effect (H3).  Thus, theoretically, 
power for group-by-time differences in the scales for H2 will be greater than H1, and 
thus we should be over-powered for these measures.   We calculated H2 power for 
difference-in-differences analyses.  As each of the scales were different, we report 
minimum detectable differences as effect sizes. 
Dr. Cutrona will lead the data analysis in years 3 & 4, working closely with Drs. Smith and 
Stroupe (statistician, cost analyst) and programmer.
5.7 Withdrawal of Subjects
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
Table 8. Seven Key Data Elements
Timi
ng
Sourc
e
1.Veteran Characteristics
Participant Demographics
1
S,C
Comorbidities, VA Utilization
1
C
2. Intervention Dose/Exposure
Number of videos watched and time spent viewing
2
S
Which was selected video?
2
S
3. Narrative Communication
Video Transportation Scale
2
S 
Homophily (personal relevance)
2
S 
4. Social Cognitive Theory
Beliefs About Medications (BMQ)
1,4
S
Self-efficacy for hypertension
(e.g.: MASES-R, PEPPI)
1,4
S
5. HTN management behaviors
Avoid Salt, Be Physically Active, Monitor your BP( H-SCALE, PEMH)
1,4
S
Talk with your doctor (H-SCALE)
1,4
S
Take Your Medicines: Morisky ; and administrative data adherence (MPR)
1,3,4
S, C
6. Primary Outcome (H1)
Measured BP (systolic/diastolic)
1,4
BP, C
7. Implementation Data/
Process Measures/Fidelity
3,4
RA, S, 
T
Text message opening (subgroup)
3
T
Responses to text assessment
3
T
Confirmation of text receipt
4
S
Phone calls for texting assistance 
3
RA
Staff time spent for implementation
3
RA
Persistence/Early Discontinuation of Texting Protocol
3
T
Reasons for discontinuation
5
P
1=Baseline, 2=Immediately post-Video Viewing; P, 3=Repeated throughout 6-month study 
period, 4 = six-month follow-up; 5= phone call to drop-out
Source:  S = Survey; C = CDW data; RA=Research assistant; T=Texting System; 
P=phone call to participant; BP = Blood pressure cuff, standard protocol (For BP 
measurement at 6-months, we will pull CDW data for the entire study participation period)
 
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
If at any time the local site PI feels the study is inappropriate for a participant or 
due to medical reasons, the PI reserves the right to discontinue/withdrawal the 
subject from the study.

If at any time a participant chooses to discontinue participation, they may do so 
with no repercussion to their care or future opportunities in research or other at 
the VA.
6.0
Reporting

Because this is a low-risk trial of an educational DVD, we do not expect SAE’s or AE’s.  
We will plan to report any SAE’s defined as death of participant or hospitalization, with 
data collected at 6-month follow-up.  We will report SAEs identified in this manner within 
5 business days of their identification.  RA at site will notify the Local Site PI of any SAE 
and notify the Bedford project manager, who will then submit a Form 119 Unanticipated 
SAE to the appropriate SharePoint folder designated for Reportable AE/SAE.   

At the time of baseline visit, patients experiencing hypertensive urgency, as defined by 
JNC as Blood Pressure Systolic >= 180 OR Diastolic >= 120, regardless of symptoms, 
will be referred to urgent care and a notification letter will be sent to their primary care 
physician.  All AE’s reported at baseline and 6-month follow-up will be recorded by the 
RA and submitted to the Bedford Project manager, who will track and submit at 
Continuing Review.
7.0
Privacy and Confidentiality

This study will obtain and keep confidential subjects’ Protected Health Information (PHI). 

All study personnel with access to PHI will be required to maintain current required 
trainings and follow protocol for maintaining records according to best practices (i.e. 
locked file cabinet, locked safe when not on VA premises and Authorization to Transport 
on file, only study personnel access to drives or other e-locations of data)
8.0
Communication Plan

The Coordinating site will be in charge of all CIRB communications and will assure 
submission of required documents.  The Project manager will meet regularly with all 
sites to ensure local notification and R&D approvals are obtained and remain current. 
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
Any changes to the protocol or HIPAA documentation will be discussed with participating 
sites and submissions/approvals will be communicated to each site as they are 
completed an obtained. 

Any SAE or AE will be communicated from the Local Site and reported to the CIRB as 
outlined based on specifics of the events.  Interim results and reports, such as DSMB 
will be forwarded to each of the participating sites in a timely manner.

Each participating site will be provided with a copy of the approved protocol; and will 
receive updates at they occur.  

Bedford PI will communicate with the LSI’s regarding timing of site closures.  
9.0
References
REFERENCES 
1.
Whelton PK, Carey RM, Aronow WS, et al. 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. J Am Coll Cardiol. 2018;71(19):e127-e248. 
2.
Armstrong K, Putt M, Halbert CH, et al. Prior experiences of racial discrimination and racial 
differences in health care system distrust. Medical care. 2013;51(2):144-150. 
3.
Schoenthaler A, Montague E, Baier Manwell L, Brown R, Schwartz MD, Linzer M. Patient-
physician racial/ethnic concordance and blood pressure control: the role of trust and medication 
adherence. Ethn Health. 2014;19(5):565-578. 
4.
Houston TK, Fix GM, Shimada SL, et al. African American Veterans Storytelling: A Multisite 
Randomized Trial to Improve Hypertension. Medical care. 2017;55 Suppl 9 Suppl 2:S50-S58.
5.
Green MC, Brock TC. The role of transportation in the persuasiveness of public narratives. J Pers 
Soc Psychol. 2000;79(5):701-721. 
6.
Kreuter MW, Holmes K, Alcaraz K, et al. Comparing narrative and informational videos to 
increase mammography in low-income African American women. Patient Educ Couns. 2010;81 
Suppl:S6-14. 
7.
Williams-Brown S, Baldwin DM, Bakos A. Storytelling as a method to teach African American 
women breast health information. J Cancer Educ. 2002;17(4):227-230. 
8.
Wolff M, Bates T, Beck B, Young S, Ahmed SM, Maurana C. Cancer prevention in underserved 
African American communities: barriers and effective strategies--a review of the literature. 
WMJ. 2003;102(5):36-40. 
9.
Kreuter MW, Holmes K, Hinyard LJ, et al. Narrative Communication in Cancer Prevention and 
Control: A Framework to Guide Research and Application. Annals of Behavioral Medicine. 
2007;33(3):221-235. 
10. Rubin AM. Parasocial Relationships. . The International Encyclopedia of Interpersonal 
Communication2015:1-5.
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