Tailored Approaches to Improve Medication Adherence
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Apr 2013
Longer than P75 for not_applicable hypertension
1 active site
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
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedResults Posted
Study results publicly available
September 26, 2019
CompletedSeptember 26, 2019
September 1, 2019
4.9 years
July 16, 2012
June 5, 2018
September 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of Retaining Study Participants Through the 3 Month Trial
Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.
3 months
Secondary Outcomes (3)
Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months
baseline and 3 months
Change From Baseline in HbA1c at 3 Months
baseline and 3 months
Change From Baseline in Self-reported Medication Adherence at 3 Months
Baseline and 3 months
Study Arms (2)
Attention Control
ACTIVE COMPARATORHealth education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
Tailored Adherence Intervention
EXPERIMENTALTablet-based tailored adherence intervention matched to patients' most salient adherence barriers
Interventions
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.
Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
Eligibility Criteria
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) 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Union Health Center
New York, New York, 10001, United States
Related Publications (2)
Schoenthaler A, Leon M, Butler M, Steinhaeuser K, Wardzinski W. Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2020 Sep 23;8(9):e17135. doi: 10.2196/17135.
PMID: 32965230DERIVEDSchoenthaler A, De La Calle F, Barrios-Barrios M, Garcia A, Pitaro M, Lum A, Rosal M. A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial. Trials. 2015 Jul 2;16:290. doi: 10.1186/s13063-015-0815-x.
PMID: 26134837DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Antoinette Schoenthaler
- Organization
- NYU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Antoinette Schoenthaler, EdD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2012
First Posted
July 18, 2012
Study Start
April 1, 2013
Primary Completion
February 20, 2018
Study Completion
May 1, 2018
Last Updated
September 26, 2019
Results First Posted
September 26, 2019
Record last verified: 2019-09