DVDs About Blood Pressure
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension |
Other: Story-Telling DVD Other: Non-Storytelling DVD |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Using Stories to Address Disparities in Hypertension |
- control of blood pressure [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 780 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Participant will receive a DVD with informational and story-telling components
|
Other: Story-Telling DVD
DVD will contain both informational and story-telling components.
|
|
Active Comparator: Arm 2
Participant will receive an informational DVD
|
Other: Non-Storytelling DVD
DVD will contain only informational component.
|
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.
We will make two DVDs of African-American veterans who will tell their success stories with controlling hypertension (HTN). We 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, we 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, we 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 we created; and the other half will watch a control, a DVD with the same medical information but without the narrative component. We will measure their blood pressure (BP) just before they watch the DVD and again six months later. We 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. We will also test the "Stories" DVD's impact on medication adherence and HTN management behaviors.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Kathryn L DeLaughter, MA | (781) 687-2878 | kathryn.delaughter@va.gov |
| Contact: Barbara G Bokhour, PhD | (781) 687-2862 | Barbara.Bokhour@va.gov |
| United States, Illinois | |
| Jesse Brown VA Medical Center, Chicago, IL | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Howard S Gordon, MD 312-569-7473 Howard.Gordon2@va.gov | |
| United States, Massachusetts | |
| VA New England Health Care System | Not yet recruiting |
| Bedford, Massachusetts, United States, 01730 | |
| Contact: Kathryn L DeLaughter, MA (781) 687-2878 kathryn.delaughter@va.gov | |
| Contact: Thomas K Houston, MD MPH (781) 687-2884 thomas.houston2@va.gov | |
| Sub-Investigator: Barbara G. Bokhour, PhD | |
| Sub-Investigator: Gemmae M Fix, BS MA PhD | |
| Sub-Investigator: Mark Evan Glickman, PhD | |
| Principal Investigator: Thomas K Houston, MD MPH | |
| United States, Pennsylvania | |
| Philadelphia VA Medical Center, Philadelphia, PA | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Rehman Shakaib, MD 843-789-7457 Shakaib.Rehman@va.gov | |
| United States, South Carolina | |
| Ralph H. Johnson VA Medical Center, Charleston, SC | Not yet recruiting |
| Charleston, South Carolina, United States, 29401-5799 | |
| Contact: Shakaib Rehman, MD 843-789-7457 shakaib.rehman@va.gov | |
| Principal Investigator: | Thomas K Houston, MD MPH | Edith Nourse Rogers Memorial Veterans Hospital, Bedford |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01276197 History of Changes |
| Other Study ID Numbers: | IIR 10-132 |
| Study First Received: | January 11, 2011 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
hypertension healthcare disparities minority health health behavior |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013