NCT00875225

Brief Summary

The purpose of this study is to test an interactive DVD intervention to encourage patients to stick to their blood pressure medication in order to achieve blood pressure control for African American patients. The intervention will convey health messages through personal patient stories who have dealt with or continue to struggle with high blood pressure. Hypothesis 1: At the end of 9 months a higher proportion of patients randomized to the intervention group will achieve appropriate blood pressure control. Hypothesis 2: At the end of 9 months a higher proportion of patients who randomized to the intervention group will report high adherence to their hypertension medications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

Enrollment Period

2.4 years

First QC Date

April 2, 2009

Last Update Submit

April 2, 2009

Conditions

Keywords

HypertensionAdherence to medications

Outcome Measures

Primary Outcomes (1)

  • Blood pressure control

    Two years

Secondary Outcomes (1)

  • Adherence to hypertension medications

    Two years

Study Arms (2)

Control DVD

ACTIVE COMPARATOR

Control DVD with usual care information

Behavioral: DVD

Intervention DVD

ACTIVE COMPARATOR

Intervention group will receive DVD with patient stories and information from health care professionals

Behavioral: Intervention DVD

Interventions

DVDBEHAVIORAL

Control group will receive usual care DVD from health professionals

Control DVD

Intervention group will receive intervention DVD with patient stories and information from health care professionals

Intervention DVD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • Clinical Diagnosis of Hypertension
  • Patient at Cooper Green Hospital
  • Provided Informed Consent
  • Age 18 or older

You may not qualify if:

  • Pregnant
  • Diagnosed with dementia, schizophrenia, bipolar illness, or other serious acute or chronic medical co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper Green Mercy Hospital

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • Houston TK, Allison JJ, Sussman M, Horn W, Holt CL, Trobaugh J, Salas M, Pisu M, Cuffee YL, Larkin D, Person SD, Barton B, Kiefe CI, Hullett S. Culturally appropriate storytelling to improve blood pressure: a randomized trial. Ann Intern Med. 2011 Jan 18;154(2):77-84. doi: 10.7326/0003-4819-154-2-201101180-00004.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Sandral Hullett, MD

    Cooper Green Mercy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

December 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations