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Clinical Trials/NCT01643473
NCT01643473
Completed
Not Applicable

Tailored Approaches to Improve Medication Adherence

NYU Langone Health1 site in 1 country42 target enrollmentApril 2013
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
NYU Langone Health
Enrollment
42
Locations
1
Primary Endpoint
Feasibility of Retaining Study Participants Through the 3 Month Trial
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.

Detailed Description

Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Black and Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single tablet delivered patient education session at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
May 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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) and Framingham Risk Scores (FRS) \>20% (or at least one CVD risk factor including hyperlipidemia or diabetes);
  • Have been prescribed at least one antihypertensive or oral anti-diabetic medication;
  • Self-identify as Latino or African American/Black
  • Be \> 18 years of age

Exclusion Criteria

  • Refuse or are unable to provide informed consent;
  • Currently participate in another hypertension study; or 2 diabetes study
  • Have significant psychiatric comorbidity
  • Plan to discontinue care at the clinic within the next 3 months
  • Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.

Outcomes

Primary Outcomes

Feasibility of Retaining Study Participants Through the 3 Month Trial

Time Frame: 3 months

Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.

Secondary Outcomes

  • Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months(baseline and 3 months)
  • Change From Baseline in Self-reported Medication Adherence at 3 Months(Baseline and 3 months)
  • Change From Baseline in HbA1c at 3 Months(baseline and 3 months)

Study Sites (1)

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