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Tailored Approaches to Improve Medication Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01643473
Recruitment Status : Completed
First Posted : July 18, 2012
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Adherence Intervention Other: Attention Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailored Approaches to Improve Medication Adherence
Study Start Date : April 2013
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Attention Control
Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
Other: Attention Control
Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes

Experimental: Tailored Adherence Intervention
Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers
Behavioral: Adherence Intervention
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643473


Locations
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United States, New York
Union Health Center
New York, New York, United States, 10001
Sponsors and Collaborators
NYU Langone Health
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Antoinette Schoenthaler, EdD NYU Langone Health
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
Study Protocol  [PDF] August 2, 2016
Statistical Analysis Plan  [PDF] May 10, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01643473    
Other Study ID Numbers: s14-00414
First Posted: July 18, 2012    Key Record Dates
Results First Posted: September 26, 2019
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Hypertension
Latinos
Medication Adherence
Blood Pressure Control
Patient-centered
Black
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases