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Completed

NCT Number: NCT01643473

Tailored Approaches to Improve Medication Adherence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union Health Center

New York, 10001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adherence intervention

Behavioral

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.

Attention Control

Other

Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes

Primary outcomes

  1. 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

  1. Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months

    Time frame: baseline and 3 months

    Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit.

  2. Change From Baseline in HbA1c at 3 Months

    Time frame: baseline and 3 months

    Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months.

  3. Change From Baseline in Self-reported Medication Adherence at 3 Months

    Time frame: Baseline and 3 months

    Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2012
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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