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The medication Adherence and Blood Pressure Control (ABC) trial: a multi-site randomized controlled trial in a
William Gerin1, Jonathan N Tobin, Joseph E Schwartz
1Columbia University, College of Physicians and Surgeons, New York-Presbyterian Hospital, New York, NY, USA. wg131@columbia.edu
Insights
The ABC Trial investigated a stepped care intervention to improve medication adherence and blood pressure (BP) control in hypertensive patients. Objective adherence measures showed the intervention
Area of Science:
- Clinical Trials
- Cardiovascular Health
- Health Behavior Interventions
Background:
- Hypertension management is challenged by poor medication adherence, particularly in diverse, low-income populations.
- Objective adherence measures like electronic monitoring are underutilized in evaluating hypertension interventions.
- Accessible, real-world interventions are needed to address medication non-adherence.
Purpose of the Study:
- To evaluate a stepped care intervention's effectiveness in improving medication adherence and blood pressure (BP) control.
- To assess interventions using objective adherence measures (Electronic Medication Event Monitoring) and BP control.
- To test a combination of accessible behavioral interventions for hypertensive patients.
Main Methods:
- Randomized, controlled, multi-site trial involving hypertensive patients in primary care.
- Intervention included home Self-BP Monitoring (SBPM) and, for uncontrolled BP, telephone-based nurse case management (SBPM+NCM).
- Primary adherence measure: Electronic Medication Event Monitoring (MEMS); primary BP control measure: in-office BP.
Main Results:
- The study design and methodology are presented, including recruitment and follow-up procedures.
- Objective adherence data (MEMS) were collected to assess intervention effectiveness.
- In-office BP was the primary outcome for hypertension control.
Conclusions:
- The ABC Trial provides a framework for testing real-world adherence interventions using objective measures.
- Findings will inform the development of practical solutions for improving medication adherence and BP control.
- The stepped care approach combined with objective monitoring offers a potential strategy for managing hypertension.
Abstract:
The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been published in which objective measures of adherence (electronic pill bottles) were used to assess the effectiveness of these behavioral interventions for hypertension. This study tested a combination of commercially-available interventions that can be easily accessed by health care providers and patients, and therefore may provide a real-world solution to the problem of non-adherence among hypertensives. The aim of the ABC Trial was to test the effectiveness of a stepped care intervention in improving both medication adherence to an antihypertensive medication regimen and BP control. Step 1 of the intervention employed home Self-BP Monitoring (SBPM); at this stage, there were two arms: (1) Usual Care (UC) and (2) Intervention. At Step 2, patients in the intervention arm whose BP had not come under control after 3 months were further randomized to one of two conditions: (1) continuation of SBPM (alone) or (2) continuation of SBPM plus telephone-based nurse case management (SBPM+NCM). Electronic Medication Event Monitoring (MEMS) was the primary measure of medication adherence, and in-office BP was the primary measure of hypertension control. We present an overview of the study design, details of the administrative structure of the study and a description of clinical site recruitment, patient recruitment, and follow-up assessments.
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