N/A
N=42
Tailored Approaches to Improve Medication Adherence
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01643473 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Feasibility of Retaining Study Participants Through the 3 Month Trial — 20; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adherence Intervention (Behavioral); Attention Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Retaining Study Participants Through the 3 Month Trial |
20; 21 | — |
| SECONDARY Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months |
-6.1; -7.2; -1.9; -3.5 | — |
| SECONDARY Change From Baseline in HbA1c at 3 Months |
0.6; -0.5 | — |
| SECONDARY Change From Baseline in Self-reported Medication Adherence at 3 Months |
1.8; 1.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01643473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.