DVDs About Blood Pressure
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 11, 2011 | ||||||||
| Last Updated Date | June 6, 2013 | ||||||||
| Start Date ICMJE | January 2013 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
control of blood pressure [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01276197 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | DVDs About Blood Pressure | ||||||||
| Official Title ICMJE | Using Stories to Address Disparities in Hypertension | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
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| Condition ICMJE | Hypertension | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 780 | ||||||||
| Estimated Completion Date | July 2015 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 19 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01276197 | ||||||||
| Other Study ID Numbers ICMJE | IIR 10-132 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Department of Veterans Affairs | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | June 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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