Using Stories to Address Disparities in Hypertension

October 21, 2016 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

618

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center, Chicago, IL
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center, Philadelphia, PA
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after intervention
Diastolic BP Measurement at Follow-up
Time Frame: 6-month following intervention
Participants BP measurement at 6-month follow-up
6-month following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 13, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 10-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to report on our primary outcome

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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