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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
  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

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • control of blood pressure [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
    Bp measurement at 6-month follow-up


Enrollment: 620
Study Start Date: January 2013
Study Completion Date: January 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Story-Telling DVD
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: Non-Storytelling DVD
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276197

Locations
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Thomas K Houston, MD MPH Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA