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Completed

NCT Number: NCT03970590

Continuing the Conversation: Using Narrative Communication to Support Hypertension Self-management in African American Veterans

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jesse Brown VA Medical Center, Chicago, IL, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: CTC

Control

Behavioral

6-month HTN management assessment text messages without narrative component

Other names: Active Comparator

Primary outcomes

  1. BP Measurement Change at Follow-up

    Time frame: From enrollment to the time of follow-up, up to 8 months

    Blood Pressure (H1), will be calculated / performed to detect a difference in the change in both Diastolic and Systolic BP, comparing intervention and control.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Continuing the Conversation: A Multi-site RCT Using Narrative Communication to Support Hypertension Self-Management Among African-American Veterans

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 31, 2019
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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