Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence
- Conditions
- HypertensionMedication Adherence
- Interventions
- Behavioral: Mi Propio Camino (MPC)Behavioral: Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)
- Registration Number
- NCT04585594
- Lead Sponsor
- University of California, Irvine
- Brief Summary
The purpose of this study is to compare the effect of two educational interventions on adherence to blood pressure medications among adults with uncontrolled hypertension.
- Detailed Description
The study is a randomized controlled trial (RCT) consisting of a 4-session educational intervention (completed over the course of 4-8 weeks) and a 6-month follow-up period for adherence monitoring. Participants will be allocated to one of two educational intervention groups following a block randomization schedule, stratified on the hypothesized mediator variable of medication-related beliefs (high versus low scores on the BMQ Necessity-Concerns subscore) to ensure the groups are balanced on this variable. Primary endpoint is medication adherence at 6 month follow-up, defined as the proportion of days that the prescribed number of doses was taken by the patient during a 30-day period, measured by a pill bottle cap monitor (medication events monitoring device \[MEMS\]).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 508
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mi Propio Camino (MPC; My Own Way) Mi Propio Camino (MPC) Participants will complete the MPC intervention alongside usual care for hypertension Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control) Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control) Participants will complete the HCP intervention alongside usual care for hypertension.
- Primary Outcome Measures
Name Time Method Medication Adherence (Objective) 6 months post-intervention Medication adherence is assessed at 6-month follow-up with Medication Event Monitoring System (MEMS) pill bottle cap monitors (MWV/WestRock), an objective, gold-standard measure for pill-taking behavior. MEMS caps can be affixed to a medicine bottle to record each time the bottle is opened, indicating when the patient took the medication. Daily adherence is defined as the proportion of days that the prescribed number of doses was taken by the patient during a 30-day period.
- Secondary Outcome Measures
Name Time Method Medication Adherence (Subjective) Collected for analysis at baseline, upon completion of intervention period and upon completion of outcome assessment period at 1-month and 6-month follow up. Subjective medication adherence assessed with a validated Spanish version of the Morisky Medication Adherence Scale (8-item MMAS), coded dichotomously (low vs. high adherence) using published cutoffs
Reasons for Nonadherence Collected for analysis at baseline, upon completion of intervention period and upon completion of outcome assessment period at 1-month and 6-month follow up. Reasons for medication nonadherence will be assessed with the Safran Medication Adherence questionnaire, coded dichotomously for nonadherence related to beliefs, nonadherence related to cost, and unintentional nonadherence
Medication-related Behavioral Skills Collected for analysis at baseline, upon completion of intervention period and upon completion of outcome assessment period at 1-month and 6-month follow up. Knowledge of Medication-related Behavioral Skills will be assessed withthe PROMIS Self-Efficacy for Managing Chronic Conditions Manage Medications/Treatment scale
Activation of behavioral strategies Collected for analysis at baseline, upon completion of intervention period and upon completion of outcome assessment period at 1-month and 6-month follow up. Activation of behavioral strategies measured with the Medication Adherence Strategies Inventory (ASI)60, an inventory of 7 common strategies for adherence.
Blood Pressure Blood pressure will be collected for analysis at baseline, upon completion of intervention period and upon completion of outcome assessment period at 1-month and 6-month follow up. This outcome measure will be recorded following the American Heart Association (AHA) and American College of Cardiology (ACC) guidelines for proper methods and accurate blood pressure (BP) measurement. Accurate BP measurements are subdivided into pre and post-steps. Before measuring of BP, patients are to be prepared for proper technique including: having the patient sit quietly with their feet on the floor, back supported and relaxed for 5 minutes, supporting arm used for measurement on a desk and ensuring it is positioned at heart level. Subsequently, the middle of the BP cuff should be positioned on the patient's upper arm ensuring that the correct cuff size is used based on the cuff size criteria from AHA. As our patients are already taking medication that might affect BP, timing of measurements should be standardized to the patient's medication intake.
Medication-related information Collected for analysis at baseline, upon completion of intervention period and upon completion of outcome assessment period at 1-month and 6-month follow up. Knowledge of medication-related information will be assessed with a questionnaire adapted from the Medication Knowledge Questionnaire (MKQ)
Medication-related beliefs (Specific) Collected for analysis at baseline, upon completion of intervention period and upon completion of outcome assessment period at 1-month and 6-month follow up. Medication-related beliefs will be assessed as the Specific Necessity-Concerns scale for the Beliefs about Medicines Questionnaire (BMQ).
Trial Locations
- Locations (1)
Health Policy Research Institute
🇺🇸Irvine, California, United States