Clinical trial NCT03970590: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
Minority Health
health behavior
text messaging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-05-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: BP Measurement Change at Follow-up
timeFrame: From enrollment to the time of follow-up, up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Sarah L Cutrona, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.