Hypertension Clinical Trial
— MPCOfficial title:
Mi Propio Camino (Finding My Own Way): Personalized Approaches to Improve Blood Pressure Control
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria are: (1) age 18 years or greater, (2) uncontrolled hypertension (BP above 140/90 mmHg), (3) Hispanic ethnicity, (4) Spanish or English-speaking, (5) at least one office visit at the study clinic in prior 12 months. Exclusion criteria: Persons with stage 4 or 5 chronic kidney disease (CKD) will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Health Policy Research Institute | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medication Adherence (Objective) | 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. | 6 months post-intervention | |
Secondary | Blood Pressure | 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. | 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. | |
Secondary | Medication Adherence (Subjective) | 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 | 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. | |
Secondary | Reasons for Nonadherence | 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 | 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. | |
Secondary | Medication-related beliefs (Specific) | Medication-related beliefs will be assessed as the Specific Necessity-Concerns scale for the Beliefs about Medicines Questionnaire (BMQ). | 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. | |
Secondary | Medication-related information | Knowledge of medication-related information will be assessed with a questionnaire adapted from the Medication Knowledge Questionnaire (MKQ) | 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. | |
Secondary | Medication-related Behavioral Skills | Knowledge of Medication-related Behavioral Skills will be assessed withthe PROMIS Self-Efficacy for Managing Chronic Conditions Manage Medications/Treatment scale | 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. | |
Secondary | Activation of behavioral strategies | Activation of behavioral strategies measured with the Medication Adherence Strategies Inventory (ASI)60, an inventory of 7 common strategies for adherence. | 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. |
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