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Using Stories to Address Disparities in Hypertension

Using Stories to Address Disparities in Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01276197
Enrollment
618
Registered
2011-01-13
Start date
2013-01-31
Completion date
2016-01-31
Last updated
2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, healthcare disparities, minority health, health behavior

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.

Interventions

OTHERStory-Telling DVD

DVD will contain both informational and story-telling components.

OTHERNon-Storytelling DVD

DVD will contain only informational component.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Systolic BP at Follow-up6 months after interventionSystolic 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-up6-month following interventionParticipants BP measurement at 6-month follow-up

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1: Story-Telling DVD
Participant will receive a DVD with informational and story-telling components Story-Telling DVD: DVD will contain both informational and story-telling components.
308
Arm 2: Non-Storytelling DVD
Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component.
310
Total618

Baseline characteristics

CharacteristicArm 1: Story-Telling DVDArm 2: Non-Storytelling DVDTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
118 Participants124 Participants242 Participants
Age, Categorical
Between 18 and 65 years
190 Participants186 Participants376 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
308 Participants310 Participants618 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
26 Participants25 Participants51 Participants
Sex: Female, Male
Male
282 Participants285 Participants567 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 3080 / 310
serious
Total, serious adverse events
12 / 30810 / 310

Outcome results

Primary

Diastolic BP Measurement at Follow-up

Participants BP measurement at 6-month follow-up

Time frame: 6-month following intervention

ArmMeasureValue (MEAN)Dispersion
Arm 1: Story-Telling DVDDiastolic BP Measurement at Follow-up80.1 mmHgStandard Deviation 13
Arm 2: Non-Storytelling DVDDiastolic BP Measurement at Follow-up81.9 mmHgStandard Deviation 13.1
Primary

Systolic BP at Follow-up

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.

Time frame: 6 months after intervention

Population: Our analyses was completed with those who completed follow-up visit and varies from participant flow as we are not able to include those lost to follow-up.

ArmMeasureValue (MEAN)Dispersion
Arm 1: Story-Telling DVDSystolic BP at Follow-up137.9 mmHgStandard Deviation 18.4
Arm 2: Non-Storytelling DVDSystolic BP at Follow-up141.2 mmHgStandard Deviation 17.8

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026