Continuing the Conversation: Using Narrative Communication to Support Hypertension Self-management in African American Veterans
Primary Purpose
Hypertension
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CTC Intervention
Control
Sponsored by

About this trial
This is an interventional health services research trial for Hypertension focused on measuring hypertension, Minority Health, health behavior, text messaging
Eligibility Criteria
Inclusion Criteria:
- 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
- Veterans who have documented HTN (ICD10 diagnosis codes: I10-essential HTN) during this 1-year period
- Patients who self-identify as African American or Black
- Participants must be on at least one medication for BP
Need to have access to their own or a family member's cell phone or smart phone for participation
- Must be willing to use this phone for receipt of text messages over a 6-month period
Exclusion Criteria:
- Veterans who participated in our previous VA Stories study
- Veteran who fail the memory and concentration questions asked in the screening survey
- Pregnant Veterans (verified by self-report)
Sites / Locations
- Jesse Brown VA Medical Center, Chicago, IL
- VA Bedford HealthCare System, Bedford, MA
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CTC
Control
Arm Description
An integrated peer narrative-based intervention (VIEW > SELECT > GET), beginning with VIEW In-person viewing of VA Stories narratives, followed by SELECT a favorite Veteran] Storyteller, and then GET favorite Storyteller "narrative-aligned" text messages over 6 months
6-month HTN management assessment text messages without narrative component
Outcomes
Primary Outcome Measures
BP Measurement Change at Follow-up
Blood Pressure (H1), will be calculated / performed to detect a difference in the change in both Diastolic and Systolic BP, comparing intervention and control.
Secondary Outcome Measures
Full Information
NCT ID
NCT03970590
First Posted
May 30, 2019
Last Updated
January 31, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03970590
Brief Title
Continuing the Conversation: Using Narrative Communication to Support Hypertension Self-management in African American Veterans
Official Title
Continuing the Conversation: A Multi-site RCT Using Narrative Communication to Support Hypertension Self-Management Among African-American Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study the investigators will conduct a randomized controlled trial aimed at improving hypertension self-management and lowering blood pressure (BP) in African-American Veterans. In this study, the investigators 'begin the conversation' by showing previously created videos to Veteran participants, inviting them to select the peer narrative that is most compelling. The investigators then 'continue the conversation', offering longitudinal support via 6 months of narrative-aligned text messages. Texts will cover key subject areas, providing education, reminders and periodic assessments, and include quotations derived from and aligned with transcripts from the chosen narrative. The investigators will measure the intervention's impact on BP, self-efficacy and self-management behaviors, and conduct a cost analysis.
Detailed Description
This project proposes to Continuing the Conversation, following a previous study in which the investigators used storytelling in African Americans Veterans, to create videos of how they manage their blood pressure. The investigators 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). The investigators' findings highlight the need for longitudinal support to sustain the storytelling effect. The 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.
The proposal, "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. The investigators' Specific aims include:
Aim 1. Refine and Pilot the Continuing the Conversation (CTC) intervention. Previously, the investigators created video-recorded stories told by African-American Veterans with HTN, describing their self-management strategies. The investigators will refine CTC by adapting content from these videos to create narrative-aligned texts and will pilot CTC.
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. The investigators 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. The investigators 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 poorly controlled HTN will be recruited from 2 VA healthcare sites with known disparities in HTN control. The investigators 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 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 Veterans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, Minority Health, health behavior, text messaging
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will conduct an RCT testing the CTC intervention (video viewing, selection of preferred narrative, narrative-aligned text messages) compared to assessment text messages alone.
Masking
Participant
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTC
Arm Type
Experimental
Arm Description
An integrated peer narrative-based intervention (VIEW > SELECT > GET), beginning with VIEW In-person viewing of VA Stories narratives, followed by SELECT a favorite Veteran] Storyteller, and then GET favorite Storyteller "narrative-aligned" text messages over 6 months
Arm Title
Control
Arm Type
Active Comparator
Arm Description
6-month HTN management assessment text messages without narrative component
Intervention Type
Behavioral
Intervention Name(s)
CTC Intervention
Other Intervention Name(s)
CTC
Intervention Description
An integrated peer narrative-based intervention (VIEW > SELECT > GET), beginning with VIEW In-person viewing of VA Stories narratives, followed by SELECT a favorite Veteran] Storyteller, and then GET favorite Storyteller "narrative-aligned" text messages over 6 months
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
Active Comparator
Intervention Description
6-month HTN management assessment text messages without narrative component
Primary Outcome Measure Information:
Title
BP Measurement Change at Follow-up
Description
Blood Pressure (H1), will be calculated / performed to detect a difference in the change in both Diastolic and Systolic BP, comparing intervention and control.
Time Frame
6-months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Veterans who have documented HTN (ICD10 diagnosis codes: I10-essential HTN) during this 1-year period
Patients who self-identify as African American or Black
Participants must be on at least one medication for BP
Need to have access to their own or a family member's cell phone or smart phone for participation
Must be willing to use this phone for receipt of text messages over a 6-month period
Exclusion Criteria:
Veterans who participated in our previous VA Stories study
Veteran who fail the memory and concentration questions asked in the screening survey
Pregnant Veterans (verified by self-report)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Cutrona, MD
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
VA Bedford HealthCare System, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730-1114
Country
United States
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4551
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators plan to report on our primary outcome. In addition, during and following this trial, the investigators will provide materials to our operational partner, the Office of Connected Care (OCC), for presentations to National Leadership Council including to VISN Directors and also explore other avenues for dissemination.
Citations:
PubMed Identifier
34855617
Citation
DeLaughter KL, Fix GM, McDannold SE, Pope C, Bokhour BG, Shimada SL, Calloway R, Gordon HS, Long JA, Miano DA, Cutrona SL. Incorporating African American Veterans' Success Stories for Hypertension Management: Developing a Behavioral Support Texting Protocol. JMIR Res Protoc. 2021 Dec 1;10(12):e29423. doi: 10.2196/29423.
Results Reference
result
Learn more about this trial
Continuing the Conversation: Using Narrative Communication to Support Hypertension Self-management in African American Veterans
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