NCT01276197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
618

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable hypertension

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 30, 2016

Completed
Last Updated

December 2, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

January 11, 2011

Results QC Date

June 16, 2016

Last Update Submit

October 21, 2016

Conditions

Keywords

hypertensionhealthcare disparitiesminority healthhealth behavior

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 months after intervention

  • Diastolic BP Measurement at Follow-up

    Participants BP measurement at 6-month follow-up

    6-month following intervention

Study Arms (2)

Arm 1: Story-Telling DVD

EXPERIMENTAL

Participant will receive a DVD with informational and story-telling components

Other: Story-Telling DVD

Arm 2: Non-Storytelling DVD

ACTIVE COMPARATOR

Participant will receive an informational DVD

Other: Non-Storytelling DVD

Interventions

DVD will contain both informational and story-telling components.

Arm 1: Story-Telling DVD

DVD will contain only informational component.

Arm 2: Non-Storytelling DVD

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (4)

  • Houston TK, Cherrington A, Coley HL, Robinson KM, Trobaugh JA, Williams JH, Foster PH, Ford DE, Gerber BS, Shewchuk RM, Allison JJ. The art and science of patient storytelling-harnessing narrative communication for behavioral interventions: the ACCE project. J Health Commun. 2011 Aug;16(7):686-97. doi: 10.1080/10810730.2011.551997. Epub 2011 May 24.

  • Fix GM, Bokhour BG. Understanding the context of patient experiences in order to explore adherence to secondary prevention guidelines after heart surgery. Chronic Illn. 2012 Dec;8(4):265-77. doi: 10.1177/1742395312441037. Epub 2012 Mar 2.

  • Fix GM, Houston TK, Barker AM, Wexler L, Cook N, Volkman JE, Bokhour BG. A novel process for integrating patient stories into patient education interventions: incorporating lessons from theater arts. Patient Educ Couns. 2012 Sep;88(3):455-9. doi: 10.1016/j.pec.2012.06.012. Epub 2012 Jul 6.

  • Houston TK, Fix GM, Shimada SL, Long JA, Gordon HS, Pope C, Volkman J, Allison JJ, DeLaughter K, Orner M, Bokhour BG. African American Veterans Storytelling: A Multisite Randomized Trial to Improve Hypertension. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S50-S58. doi: 10.1097/MLR.0000000000000766.

MeSH Terms

Conditions

HypertensionHealth Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Limitations and 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.

Results Point of Contact

Title
Dr. Thomas K. Houston
Organization
CHOIR

Study Officials

  • Thomas K Houston, MD MPH

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 13, 2011

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

January 1, 2016

Last Updated

December 2, 2016

Results First Posted

September 30, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

We plan to report on our primary outcome

Locations