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Discovering Healthcare Innovations to Address Disparities in Stroke (DIADS) (DIADS)

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ClinicalTrials.gov Identifier: NCT01892592
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and to reduce racial disparity in HTN control. To accomplish this, the investigators propose to perform a cluster randomized controlled trial at the primary care provider (PCP) level and including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the HTN registry of which approximately 15,000 are black. The investigators will randomize all PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with pharmacotherapy. The "Shake, Rattle and Roll" trial is named for: 1) "shake" the salt habit; 2) "rattle" the intensity of current BP management; and 3) design the interventions with the goal of being able to adapt and "roll" them out to community clinics outside of a managed care system. Primary research question: whether a primary prevention intervention of either diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than usual care in improving rates of HTN control in blacks and thereby reducing disparities between black and white. Primary aim: By implementing either intervention, the investigators will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1 year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching intervention or an intensified BP management protocol will result in an increase in HTN control rate compared to usual care. Primary outcome: the proportion of patients with sustained BP control at 1 year post-study enrollment.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Diet and Lifestyle Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3698 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Discovering Healthcare Innovations to Address Disparities in Stroke
Study Start Date : June 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Usual Care
No Interventions
No Intervention: Medication enhancement
Pharmacist will optimize current Kaiser medication protocol for treatment of hypertension.
Experimental: Diet and Lifestyle Arm
Patients will receive up to 16 wellness coaching sessions focusing on DASH doest and lifestyle changes - Behavioral Intervention
Behavioral: Diet and Lifestyle
Patients will receive up to 16 phone based coaching sessions
Other Names:
  • Behavioral Interventions
  • Wellenss Coaching



Primary Outcome Measures :
  1. Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year. [ Time Frame: 1 year ]
    Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American
  • > age 18
  • Blood Pressure >140/90

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892592


Locations
United States, California
Kaiser Permanene Oakland Medical Center
Oakland, California, United States, 94611
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Mai N Nguyen-Huynh, MD Research Scientist

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01892592     History of Changes
Other Study ID Numbers: CN-12SSidn-06-H
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016

Keywords provided by Kaiser Permanente:
Hypertension
African American
Health Disparities
Stroke
Cardiovascular Disease

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases