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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT01892592 History of Changes
Other Study ID Numbers:	CN-12SSidn-06-H
First Posted:	July 4, 2013
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