Using Stories to Address Disparities in Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Non-Storytelling DVD; Other: Story-Telling DVD

• Registration Number: NCT01276197
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Study Start: 2013-01
• Primary Completion: 2015-05
• Study Completion: 2016-01
• Results First Submitted: 2016-06-16
• Results First Submitted QC: 2016-08-05
• Results First Posted: 2016-09-30
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

• African-American
• Diagnosis of HTN
• Uncontrolled BP as defined by BP >140/90 twice in the preceding 12 months

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Exclusion Criteria

• active substance abuse
• severe mental illness
• cognitive disabilities that might prevent them from actively or reliably participating in the interviews

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Non-Storytelling DVD	Non-Storytelling DVD	Participant will receive an informational DVD
Arm 1: Story-Telling DVD	Story-Telling DVD	Participant will receive a DVD with informational and story-telling components

Primary Outcome Measures

Name	Time	Method
Systolic BP at Follow-up	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.
Diastolic BP Measurement at Follow-up	6-month following intervention	Participants BP measurement at 6-month follow-up

Trial Locations

Locations (4)

Philadelphia VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA; 🇺🇸 Bedford, Massachusetts, United States

Ralph H. Johnson VA Medical Center, Charleston, SC; 🇺🇸 Charleston, South Carolina, United States

Jesse Brown VA Medical Center, Chicago, IL; 🇺🇸 Chicago, Illinois, United States