Hypertension
Conditions
Keywords
hypertension, healthcare disparities, minority health, health behavior
Brief summary
The purpose of this study is to determine if patients with high blood pressure are better able to control their blood pressure after watching a DVD about blood pressure.
Detailed description
This project consists of two phases: (1) Collecting of stories and creating a stories DVD; and (2) delivering the DVD in a randomized control trial (RCT). Both phases are described below. The investigators will make two DVDs of African-American Veterans who will tell their success stories with controlling hypertension (HTN). The investigators want to help African-American Veterans control their hypertension by showing them stories that are interesting and that they can identify with, as well as giving them information about ways they can manage hypertension in their everyday lives. This is important because a disproportionate number of minority patients, including Veterans, have poorly controlled blood pressure. By showing them stories, rather than using more traditional methods of health education, the investigators hope to overcome some typical barriers to HTN control among the African-American population, including: lower levels of health literacy and numeracy, less trust in the medical system, and different (non-medical) models to explain their illness. The Veteran storytellers will come from three VA sites (Charleston, Chicago, and Philadelphia) and their stories will be chosen based on (1) the proven effectiveness of the strategies they suggest for controlling BP and (2) how authentic they are, or how much they will ring true with the experiences of other Veterans, including their struggles and lessons learned. After the DVD is complete, the investigators will conduct a randomized control trial to evaluate how effective it is in helping vets control their hypertension: 780 African-American vets with uncontrolled hypertension, from the same three VA sites, will participate. Half of them will watch the Stories DVD the investigators created; and the other half will watch a control, a DVD with the same medical information but without the narrative component. The investigators will measure their blood pressure (BP) just before they watch the DVD and again six months later. The investigators hypothesize that, six months after enrollment, the Veterans who watched the Stories DVD will have greater reduction in BP, as compared with those who watch the control. The investigators will also test the Stories DVD's impact on medication adherence and HTN management behaviors.
Interventions
DVD will contain both informational and story-telling components.
DVD will contain only informational component.
Sponsors
Study design
Eligibility
Inclusion criteria
* African-American * Diagnosis of HTN * Uncontrolled BP as defined by BP \>140/90 twice in the preceding 12 months
Exclusion criteria
* active substance abuse * severe mental illness * cognitive disabilities that might prevent them from actively or reliably participating in the interviews
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic BP at Follow-up | 6 months after intervention | Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate. |
| Diastolic BP Measurement at Follow-up | 6-month following intervention | Participants BP measurement at 6-month follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Story-Telling DVD Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components. | 308 |
| Arm 2: Non-Storytelling DVD Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component. | 310 |
| Total | 618 |
Baseline characteristics
| Characteristic | Arm 1: Story-Telling DVD | Arm 2: Non-Storytelling DVD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 118 Participants | 124 Participants | 242 Participants |
| Age, Categorical Between 18 and 65 years | 190 Participants | 186 Participants | 376 Participants |
| 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 | 308 Participants | 310 Participants | 618 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 |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 282 Participants | 285 Participants | 567 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 308 | 0 / 310 |
| serious Total, serious adverse events | 12 / 308 | 10 / 310 |
Outcome results
Diastolic BP Measurement at Follow-up
Participants BP measurement at 6-month follow-up
Time frame: 6-month following intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Story-Telling DVD | Diastolic BP Measurement at Follow-up | 80.1 mmHg | Standard Deviation 13 |
| Arm 2: Non-Storytelling DVD | Diastolic BP Measurement at Follow-up | 81.9 mmHg | Standard Deviation 13.1 |
Systolic BP at Follow-up
Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.
Time frame: 6 months after intervention
Population: Our analyses was completed with those who completed follow-up visit and varies from participant flow as we are not able to include those lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Story-Telling DVD | Systolic BP at Follow-up | 137.9 mmHg | Standard Deviation 18.4 |
| Arm 2: Non-Storytelling DVD | Systolic BP at Follow-up | 141.2 mmHg | Standard Deviation 17.8 |