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

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ClinicalTrials.gov Identifier: NCT03970590
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: CTC Intervention Behavioral: Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Continuing the Conversation: A Multi-site RCT Using Narrative Communication to Support Hypertension Self-Management Among African-American Veterans
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: 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
Other Name: CTC

Active Comparator: Control
6-month HTN management assessment text messages without narrative component
Behavioral: Control
6-month HTN management assessment text messages without narrative component
Other Name: Active Comparator




Primary Outcome Measures :
  1. BP Measurement Change at Follow-up [ Time Frame: 6-months after intervention ]
    Blood Pressure (H1), will be calculated / performed to detect a difference in the change in both Diastolic and Systolic BP, comparing intervention and control.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970590


Contacts
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Contact: Sarah L Cutrona, MD (781) 687-2861 sarah.cutrona@va.gov
Contact: Barbara G Bokhour, PhD (781) 687-2862 Barbara.Bokhour@va.gov

Locations
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United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Howard Gordon, MD    312-569-7473    howard.gordon2@va.gov   
Contact: Vairneke Westmoreland, MS    3125698901    vairneke.westmoreland@va.gov   
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Active, not recruiting
Bedford, Massachusetts, United States, 01730
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Judith Long, MD    215-823-5800 ext 716    judith.long@va.gov   
Contact: Tanisha Dicks, MPH    2158235800 ext 715    tanisha.dicks@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sarah L Cutrona, MD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03970590     History of Changes
Other Study ID Numbers: IIR 17-185
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan to report on our primary outcome. In addition, during and following this trial, we 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
hypertension
Minority Health
health behavior
text messaging

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases