NCT03970590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 30, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 3, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

May 30, 2019

Results QC Date

October 29, 2024

Last Update Submit

March 13, 2025

Conditions

Keywords

hypertensionMinority Healthhealth behaviortext messaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Behavioral: CTC Intervention

Control

ACTIVE COMPARATOR

6-month HTN management assessment text messages without narrative component

Behavioral: Control

Interventions

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

Also known as: CTC
CTC
ControlBEHAVIORAL

6-month HTN management assessment text messages without narrative component

Also known as: Active Comparator
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

HypertensionHealth Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Results Point of Contact

Title
Sarah Cutrona, MD
Organization
VA Bedford Healthcare System Center for Health Organization and Implementation Research

Study Officials

  • Sarah L Cutrona, MD

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2019

First Posted

May 31, 2019

Study Start

January 30, 2021

Primary Completion

May 4, 2023

Study Completion

May 4, 2023

Last Updated

April 3, 2025

Results First Posted

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Locations