Discovering Healthcare Innovations to Address Disparities in Stroke (DIADS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01892592
First received: March 21, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention
Hypertension
Behavioral: Diet and Lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discovering Healthcare Innovations to Address Disparities in Stroke

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.


Enrollment: 3698
Study Start Date: June 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892592

Locations
United States, California
Kaiser Permanene Oakland Medical Center
Oakland, California, United States, 94611
Sponsors and Collaborators
Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01892592     History of Changes
Other Study ID Numbers: CN-12SSidn-06-H
Study First Received: March 21, 2013
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014