Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence (MPC)

University of California Irvine (UCI)

Status: Completed

Conditions: Hypertension; Medication Adherence

Treatments: Behavioral: Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control); Behavioral: Mi Propio Camino (MPC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04585594

1R01HL142964 (U.S. NIH Grant/Contract)

20174025

Details and patient eligibility

About

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.

Full 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]).

Enrollment: 508 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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508 participants in 2 patient groups

Mi Propio Camino (MPC; My Own Way)

Experimental group

Description:

Participants will complete the MPC intervention alongside usual care for hypertension

Treatment:

Behavioral: Mi Propio Camino (MPC)

Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)

Active Comparator group

Description:

Participants will complete the HCP intervention alongside usual care for hypertension.

Treatment:

Behavioral: Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)