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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTC | Experimental | 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 |
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| Control | Active Comparator | 6-month HTN management assessment text messages without narrative component |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTC Intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the time of follow-up, up to 8 months |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah L Cutrona, MD | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States | ||
| VA Bedford HealthCare System, Bedford, MA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34855617 | Result | 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. | |
| 41191358 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CTC Intervention | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2022 | Sep 23, 2024 |
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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.
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| Control | Behavioral | 6-month HTN management assessment text messages without narrative component |
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| Bedford |
| Massachusetts |
| 01730-1114 |
| United States |
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104-4551 | United States |
| Cutrona SL, McDannold SE, DeLaughter KL, Fix GM, Shimada SL, Bokhour BG, Gordon HS, Pope C, Smith BM, Ndiwane N, Gardner J, DeFelice DC, Bal ES, Long JA. Text Messaging and Video Stories to Support Hypertension Self-Management in Black Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2541342. doi: 10.1001/jamanetworkopen.2025.41342. |
| Control |
6-month HTN management assessment text messages without narrative component Control: 6-month HTN management assessment text messages without narrative component |
| COMPLETED |
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| NOT COMPLETED |
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Participant recruitment goals were met at 300 enrolled for each of the two study sites. Randomized assignment to Intervention/Control was used, resulting in 300 participants for each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | CTC Intervention | 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 |
| BG001 | Control | 6-month HTN management assessment text messages without narrative component Control: 6-month HTN management assessment text messages without narrative component |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Some participants declined to answer certain questions. | Count of Participants | Participants |
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| Age, Continuous | Some participants declined to answer. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Some participants declined to answer. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | 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. | Participants who completed study follow-up. | Posted | Mean | Standard Deviation | mmHg | From enrollment to the time of follow-up, up to 8 months |
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Adverse Event data were collected during the study period from enrollment to the time of follow-up, up to 8 months for each participant, and more specifically, at the time of follow-up if study staff learned of a participant death. Participants were enrolled beginning January 2021, and follow-ups were conducted beginning July 2021. Adverse event data collection was completed May 4, 2023, at study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CTC Intervention | 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 | 5 | 300 | 0 | 300 | 0 | 300 |
| EG001 | Control | 6-month HTN management assessment text messages without narrative component Control: 6-month HTN management assessment text messages without narrative component | 4 | 300 | 0 | 300 | 0 | 300 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Cutrona, MD | VA Bedford Healthcare System Center for Health Organization and Implementation Research | 781-687-2861 | sarah.cutrona@va.gov |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2018 | Sep 23, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2022 | Jan 31, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| Between 18 and 65 years |
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| >=65 years |
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