NCT03563872

Brief Summary

This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
withdrawn

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

June 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

June 10, 2018

Last Update Submit

February 21, 2019

Conditions

Hypertension

Keywords

hypertensionteam-basedguidelinesimplementation

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure

    mean change

    12 months

Secondary Outcomes (4)

  • Therapeutic Intensity

    12 months

  • Change in systolic blood pressure

    6 months

  • Change in diastolic blood pressure

    12 months

  • Treatment Congruence

    12 months

Other Outcomes (1)

  • Cost effectiveness

    12 months

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Team-based care

Other: Active Comparator

Intervention

EXPERIMENTAL

Enhanced team-based care

Other: Intervention

Interventions

InterventionOTHER

Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.

Intervention
Active ComparatorOTHER

Usual, team-based care

Active Comparator

Eligibility Criteria

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

You may qualify if:

  • Adult (\>18 years) African Americans
  • Lacks established primary care for BP management
  • History of HTN
  • SBP ≥ 140 mmHg

You may not qualify if:

  • Pregnancy
  • Need for hospitalization from ED
  • Serious comorbid conditions
  • Alcohol or drug dependence
  • Suspected resistant HTN
  • Anticipated poor-adherence to study designated primary care clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff

Study Record Dates

First Submitted

June 10, 2018

First Posted

June 20, 2018

Study Start

February 1, 2019

Primary Completion

March 1, 2021

Study Completion

January 1, 2024

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

US(1)