NCT01892592

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,761

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

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

March 21, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

March 21, 2013

Last Update Submit

May 18, 2022

Conditions

Hypertension

Keywords

HypertensionAfrican AmericanHealth DisparitiesStrokeCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.

    Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.

    1 year

Study Arms (3)

Usual Care

NO INTERVENTION

No Interventions

Medication enhancement

NO INTERVENTION

Pharmacist will optimize current Kaiser medication protocol for treatment of hypertension.

Diet and Lifestyle Arm

EXPERIMENTAL

Patients will receive up to 16 wellness coaching sessions focusing on DASH doest and lifestyle changes - Behavioral Intervention

Behavioral: Diet and Lifestyle

Interventions

Diet and LifestyleBEHAVIORAL

Patients will receive up to 16 phone based coaching sessions

Also known as: Behavioral Interventions, Wellenss Coaching
Diet and Lifestyle Arm

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanene Oakland Medical Center

Oakland, California, 94611, United States

Location

Related Publications (2)

  • Nguyen-Huynh MN, Young JD, Ovbiagele B, Alexander JG, Alexeeff S, Lee C, Blick N, Caan BJ, Go AS, Sidney S. Effect of Lifestyle Coaching or Enhanced Pharmacotherapy on Blood Pressure Control Among Black Adults With Persistent Uncontrolled Hypertension: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212397. doi: 10.1001/jamanetworkopen.2022.12397.

    PMID: 35583869DERIVED

  • Nguyen-Huynh MN, Young JD, Alexeeff S, Hatfield MK, Sidney S. Shake Rattle & Roll - Design and rationale for a pragmatic trial to improve blood pressure control among blacks with persistent hypertension. Contemp Clin Trials. 2019 Jan;76:85-92. doi: 10.1016/j.cct.2018.11.012. Epub 2018 Nov 28.

    PMID: 30500558DERIVED

MeSH Terms

Conditions

HypertensionStrokeCardiovascular Diseases

Interventions

DietBehavior Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mai N Nguyen-Huynh, MD

    Research Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

July 4, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2018

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations

US(1)