Using Stories to Address Disparities in Hypertension
|ClinicalTrials.gov Identifier: NCT01276197|
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : September 30, 2016
Last Update Posted : December 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Story-Telling DVD Other: Non-Storytelling DVD||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- Diastolic BP Measurement at Follow-up [ Time Frame: 6-month following intervention ]Participants BP measurement at 6-month follow-up
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Thomas K Houston, MD MPH||Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|