Hypertension
Conditions
Keywords
hypertension, Minority Health, health behavior, text messaging
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.
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.
Interventions
BEHAVIORALControl
6-month HTN management assessment text messages without narrative component
BEHAVIORALCTC 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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BP Measurement Change at Follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 300 |
| Control 6-month HTN management assessment text messages without narrative component
Control: 6-month HTN management assessment text messages without narrative component | 300 |
| Total | 600 |
Baseline characteristics
| Characteristic | Control | Total | CTC Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 148 Participants | 288 Participants | 140 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants | 298 Participants | 148 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 9 | 64 years STANDARD_DEVIATION 9 | 64 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 300 Participants | 600 Participants | 300 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 300 Participants | 600 Participants | 300 Participants |
| Sex: Female, Male Female | 58 Participants | 128 Participants | 70 Participants |
| Sex: Female, Male Male | 240 Participants | 469 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 300 | 4 / 300 |
| other Total, other adverse events | 0 / 300 | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 | 0 / 300 |
Outcome results
Primary
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.
Time frame: From enrollment to the time of follow-up, up to 8 months
Population: Participants who completed study follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CTC Intervention | BP Measurement Change at Follow-up | Systolic | 132 mmHg | Standard Deviation 17 |
| CTC Intervention | BP Measurement Change at Follow-up | Diastolic | 80 mmHg | Standard Deviation 11 |
| Control | BP Measurement Change at Follow-up | Systolic | 133 mmHg | Standard Deviation 15 |
| Control | BP Measurement Change at Follow-up | Diastolic | 78 mmHg | Standard Deviation 12 |