NCT03560596

Brief Summary

Poor medication adherence is a major contributor to inadequate BP control, and is associated with 125,000 deaths annually. Translation of adherence interventions to community-based primary care practices where majority of Latino patients receive care is non-existent. Thus, the development of tailored interventions targeted at improving medication adherence in the Latino population is needed in order to address the racial disparities in BP control between Latinos and whites. This proposal provides a unique opportunity to address this gap in the literature. Using a randomized control design (RCT), the study will evaluate the effect of a culturally tailored, practice-based intervention on medication adherence in 148 high-risk Latino patients with uncontrolled HTN. To facilitate translation into routine practices, the intervention will be integrated into the clinic's electronic medical record (EMR) system, and will be delivered by trained, bilingual Health Coaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 4, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

3.2 years

First QC Date

June 6, 2018

Last Update Submit

July 24, 2018

Conditions

Hypertension

Keywords

Latino

Outcome Measures

Primary Outcomes (1)

  • Rate of Medication Adherence assessed with electronic drug monitoring devices (EMD)

    Adherence will be defined as the number of times the EMD records an opening of the pill bottle cap for each day the patient was in the study.

    6 Months

Secondary Outcomes (3)

  • Self-reported medication adherence

    6 Months

  • Blood pressure reduction

    6 Months

  • Blood pressure control

    6 months

Study Arms (2)

High Risk Latino Patients Adherence Intervention

EXPERIMENTAL

74 high risk Latinos with uncontrolled hypertension

Behavioral: Adherence Intervention

High Risk Latinos Usual Care

ACTIVE COMPARATOR

74 high risk Latinos with uncontrolled hypertension

Behavioral: Usual Care

Interventions

Adherence InterventionBEHAVIORAL

9 sessions with bilingual health coaches who will utilize a culturally tailored adherence checklist to identify patients specific medication adherence barriers.

High Risk Latino Patients Adherence Intervention
Usual CareBEHAVIORAL

standard hypertension treatment recommendations as determined by PCP

High Risk Latinos Usual Care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have uncontrolled hypertension defined as BP\>140/90 mmHg on at least two consecutive visits in the past year (or BP\>130/80 mmHg for those with diabetes or kidney disease)
  • Framingham Risk Scores (FRS) \>20% (or at least one CVD risk factor including hyperlipidemia or diabetes)
  • Be taking at least one antihypertensive medication;
  • Self-identify as Latino

You may not qualify if:

  • Refuse or are unable to provide informed consent;
  • Currently participate in another hypertension study;
  • Have significant psychiatric comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • Schoenthaler A, de la Calle F, Pitaro M, Lum A, Chaplin W, Mogavero J, Rosal MC. A Systems-Level Approach to Improving Medication Adherence in Hypertensive Latinos: a Randomized Control Trial. J Gen Intern Med. 2020 Jan;35(1):182-189. doi: 10.1007/s11606-019-05419-3. Epub 2019 Oct 17.

    PMID: 31625041DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Antoinette Schoenthaler

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 18, 2018

Study Start

April 4, 2013

Primary Completion

June 4, 2016

Study Completion

August 1, 2017

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

US(1)