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

NCT ID: NCT03970590

Last Updated: 2025-04-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-30

Study Completion Date

2023-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CTC

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

Group Type EXPERIMENTAL

CTC Intervention

Intervention Type 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

Control

6-month HTN management assessment text messages without narrative component

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

6-month HTN management assessment text messages without narrative component

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Control

6-month HTN management assessment text messages without narrative component

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CTC Active Comparator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah L Cutrona, MD

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Site Status

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

Site Status

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 34855617 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIR 17-185

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motivational Interviewing
NCT00208104 TERMINATED NA