NCT01428011

Brief Summary

The purpose of this study is to understand how communication between African American and white patients with high blood pressure and his/her primary care provider effects whether a patient decides to take their high blood pressure medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

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

August 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2015

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

August 31, 2011

Last Update Submit

October 16, 2017

Conditions

Hypertension

Keywords

HypertensionPatient-Provider CommunicationMedication AdherenceRace Concordance

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    Medication adherence will be assessed as a continuous variable with the Medication Event Monitoring System (MEMS) and calculated as the percent of prescribed doses removed by the patient during the 3-month stud

    3-months

Secondary Outcomes (1)

  • patient-provider communication

    Baseline

Study Arms (1)

No treatment

African American/Black and Caucasian/White patients with hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from Primary Care Clinics in New York City

You may qualify if:

  • self-identification as black/African American or white/Caucasian
  • Receiving care in the Bellevue Hospital Ambulatory Care Practice from the same primary care provider for at least 3 months;
  • Diagnosed with hypertension (ICD: # 401-401.9)
  • Taking at least one antihypertensive medication;
  • Age18 years or older
  • Fluent in English

You may not qualify if:

  • Unable to give informed consent
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bellevue Hospital Ambulatory Care Practive

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Antoinette Schoenthaler, EdD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 2, 2011

Study Start

March 1, 2014

Primary Completion

April 22, 2015

Study Completion

April 22, 2015

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

US(1)