Continuing the Conversation: Using Narrative Communication to Support Hypertension Self-management in African American Veterans
Continuing the Conversation: A Multi-site RCT Using Narrative Communication to Support Hypertension Self-Management Among African-American Veterans
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Jesse Brown VA Medical Center, Chicago, IL
-
-
Massachusetts
-
Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104-4551
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
6-month HTN management assessment text messages without narrative component
|
6-month HTN management assessment text messages without narrative component
Other Names:
|
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the time of follow-up, up to 8 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah L Cutrona, MD, VA Bedford HealthCare System, Bedford, MA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 17-185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.