Using Stories to Address Disparities in Hypertension

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01276197
• Collaborator: (none)
• Enrollment: 618
• Locations: 4
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 154.5
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jan 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Diastolic BP Measurement at Follow-up [6-month following intervention]

   Participants BP measurement at 6-month follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois	United States	60612
2	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts	United States	01730
3	Philadelphia VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania	United States	19104
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01276197
• Other Study ID Numbers: IIR 10-132
• First Posted: Jan 13, 2011
• Last Update Posted: Dec 2, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by VA Office of Research and Development: hypertension; healthcare disparities; minority health; health behavior
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	Arm 1: Story-Telling DVD	Arm 2: Non-Storytelling DVD
Arm/Group Description	Participant will receive a DVD with informational and story-telling components Story-Telling DVD: DVD will contain both informational and story-telling components.	Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component.
Period Title: Overall Study
STARTED	308	310
COMPLETED	200	200
NOT COMPLETED	108	110

Baseline Characteristics

Arm/Group Title	Arm 1: Story-Telling DVD	Arm 2: Non-Storytelling DVD	Total
Arm/Group Description	Participant will receive a DVD with informational and story-telling components Story-Telling DVD: DVD will contain both informational and story-telling components.	Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component.	Total of all reporting groups
Overall Participants	308	310	618
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	190 61.7%	186 60%	376 60.8%
>=65 years	118 38.3%	124 40%	242 39.2%
Sex: Female, Male (Count of Participants)
Female	26 8.4%	25 8.1%	51 8.3%
Male	282 91.6%	285 91.9%	567 91.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	308 100%	310 100%	618 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Systolic BP at Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1: Story-Telling DVD	Arm 2: Non-Storytelling DVD
Arm/Group Description	Participant will receive a DVD with informational and story-telling components Story-Telling DVD: DVD will contain both informational and story-telling components.	Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component.
Measure Participants	264	270
Mean (Standard Deviation) [mmHg]	137.9 (18.4)	141.2 (17.8)

2. Primary Outcome

Title	Diastolic BP Measurement at Follow-up
Description	Participants BP measurement at 6-month follow-up
Time Frame	6-month following intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Story-Telling DVD	Arm 2: Non-Storytelling DVD
Arm/Group Description	Participant will receive a DVD with informational and story-telling components Story-Telling DVD: DVD will contain both informational and story-telling components.	Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component.
Measure Participants	264	270
Mean (Standard Deviation) [mmHg]	80.1 (13.0)	81.9 (13.1)

Adverse Events

Arm/Group Title	Arm 1: Story-Telling DVD		Arm 2: Non-Storytelling DVD
Arm/Group Description	Participant will receive a DVD with informational and story-telling components Story-Telling DVD: DVD will contain both informational and story-telling components.		Participant will receive an informational DVD Non-Storytelling DVD: DVD will contain only informational component.
All Cause Mortality
	Arm 1: Story-Telling DVD		Arm 2: Non-Storytelling DVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: Story-Telling DVD		Arm 2: Non-Storytelling DVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/308 (3.9%)		10/310 (3.2%)
Cardiac disorders
Hospitalization	10/308 (3.2%)	10	8/310 (2.6%)	8
Congenital, familial and genetic disorders
Death	2/308 (0.6%)	2	2/310 (0.6%)	2
Other (Not Including Serious) Adverse Events
	Arm 1: Story-Telling DVD		Arm 2: Non-Storytelling DVD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/308 (0%)		0/310 (0%)

Limitations/Caveats

Our multi-site trial was limited by challenges in recruitment (lower enrollment at one site) that resulted in overall recruitment lower than planned. Further, we did have some loss to follow-up.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.