Using Stories to Address Disparities in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01276197
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : September 30, 2016
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Story-Telling DVD Other: Non-Storytelling DVD Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Using Stories to Address Disparities in Hypertension
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Systolic BP at Follow-up [ Time Frame: 6 months after intervention ]
    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.

  2. Diastolic BP Measurement at Follow-up [ Time Frame: 6-month following intervention ]
    Participants BP measurement at 6-month follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01276197

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
Principal Investigator: Thomas K Houston, MD MPH Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT01276197     History of Changes
Other Study ID Numbers: IIR 10-132
First Posted: January 13, 2011    Key Record Dates
Results First Posted: September 30, 2016
Last Update Posted: December 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to report on our primary outcome

Keywords provided by VA Office of Research and Development:
healthcare disparities
minority health
health behavior

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases