DVDs About Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01276197
First received: January 11, 2011
Last updated: February 17, 2016
Last verified: February 2016

January 11, 2011
February 17, 2016
January 2013
May 2015   (final data collection date for primary outcome measure)
control of blood pressure [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
Bp measurement at 6-month follow-up
control of blood pressure [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01276197 on ClinicalTrials.gov Archive Site
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DVDs About Blood Pressure
Using Stories to Address Disparities in Hypertension
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Hypertension
  • Other: Story-Telling DVD
    DVD will contain both informational and story-telling components.
  • Other: Non-Storytelling DVD
    DVD will contain only informational component.
  • Experimental: Arm 1: Story-Telling DVD
    Participant will receive a DVD with informational and story-telling components
    Intervention: Other: Story-Telling DVD
  • Active Comparator: Arm 2: Non-Storytelling DVD
    Participant will receive an informational DVD
    Intervention: Other: Non-Storytelling DVD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
620
January 2016
May 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01276197
IIR 10-132
Yes
Not Provided
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VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Thomas K Houston, MD MPH Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
VA Office of Research and Development
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP