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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Story-Telling DVD | Experimental | Participant will receive a DVD with informational and story-telling components |
|
| Arm 2: Non-Storytelling DVD | Active Comparator | Participant will receive an informational DVD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Story-Telling DVD | Other | DVD will contain both informational and story-telling components. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after intervention |
| Diastolic BP Measurement at Follow-up | Participants BP measurement at 6-month follow-up | 6-month following intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas K Houston, MD MPH | Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States | ||
| Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21541875 | Result | Houston TK, Cherrington A, Coley HL, Robinson KM, Trobaugh JA, Williams JH, Foster PH, Ford DE, Gerber BS, Shewchuk RM, Allison JJ. The art and science of patient storytelling-harnessing narrative communication for behavioral interventions: the ACCE project. J Health Commun. 2011 Aug;16(7):686-97. doi: 10.1080/10810730.2011.551997. Epub 2011 May 24. | |
| 22387691 |
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We plan to report on our primary outcome
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm 2: Non-Storytelling DVD | Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Arm 2: Non-Storytelling DVD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 6 months after intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Congenital, familial and genetic disorders | Non-systematic Assessment |
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Our multi-site trial was limited by challenges in recruitment (lower enrollment at one site) that resulted in overall recruitment lower than planned. Further, we did have some loss to follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas K. Houston | CHOIR | 781-687-2884 | thomas.houston2@va.gov |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| Non-Storytelling DVD | Other | DVD will contain only informational component. |
|
| Bedford |
| Massachusetts |
| 01730 |
| United States |
| Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | United States |
| Fix GM, Bokhour BG. Understanding the context of patient experiences in order to explore adherence to secondary prevention guidelines after heart surgery. Chronic Illn. 2012 Dec;8(4):265-77. doi: 10.1177/1742395312441037. Epub 2012 Mar 2. |
| 22770814 | Result | Fix GM, Houston TK, Barker AM, Wexler L, Cook N, Volkman JE, Bokhour BG. A novel process for integrating patient stories into patient education interventions: incorporating lessons from theater arts. Patient Educ Couns. 2012 Sep;88(3):455-9. doi: 10.1016/j.pec.2012.06.012. Epub 2012 Jul 6. |
| 28806366 | Derived | Houston TK, Fix GM, Shimada SL, Long JA, Gordon HS, Pope C, Volkman J, Allison JJ, DeLaughter K, Orner M, Bokhour BG. African American Veterans Storytelling: A Multisite Randomized Trial to Improve Hypertension. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S50-S58. doi: 10.1097/MLR.0000000000000766. |
Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component. |
|
|
| Primary | Diastolic BP Measurement at Follow-up | Participants BP measurement at 6-month follow-up | Posted | Mean | Standard Deviation | mmHg | 6-month following intervention |
|
|
|
| 12 |
| 308 |
| 0 |
| 308 |
| EG001 | Arm 2: Non-Storytelling DVD | Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component. | 10 | 310 | 0 | 310 |
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
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