Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence

NCT ID: NCT04585594

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2024-09-10

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]).

Conditions

Hypertension; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mi Propio Camino (MPC; My Own Way)

Participants will complete the MPC intervention alongside usual care for hypertension

Group Type: EXPERIMENTAL

Mi Propio Camino (MPC)

Intervention Type: BEHAVIORAL

The Mi Propio Camino (MPC) intervention will be comprised of four sessions. Session 1 will encompass: the facts about high blood pressure (BP), understanding blood pressure readings, provide an overview of changes one can make to manage their BP, introduce MPC personal experience monitoring, and usage the mHealth kit. Subsequently, sessions 2-4 will emphasize the benefits of personal experience monitoring through 1) personal insight (finding what works for them) and 2) empowerment to work with their providers. Session 2 will reinforce this by introducing: synergy between medication and lifestyle, principles of heart-healthy eating and physical activity. Session 3 will incorporate discussion of negative beliefs about medication and patient directed lifestyle learning-rotating stations. Lastly, session 4 will introduce the continuation of personal experience monitoring on their own through the use of behavioral strategies for adherence and provider communication strategies.

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

The HCP intervention will be comprised of four sessions and introduce seven lifestyle strategies (LS) subdivided per these sessions. Session 1 will encompass the facts about high blood pressure (BP), understanding blood pressure readings, provide an overview of changes one can make to manage their BP, present specific health threats from high BP, and incorporate LS1: taking control of your medication. Subsequently, sessions 2-4 will reinforce the benefits of taking medications through presenting 1) reduced risk for complications and 2) strategies to remember to take medications. Session 2 will present LS2: eating a well-balanced, low-salt diet and LS3: enjoying regular physical activity. Session 3 will follow with introducing LS4: maintaining a healthy weight and LS5: shaking the salt habit while eating out. Session 4 will present LS6: managing stress and LS7: working together with their doctor followed by a review of strategies they can continue on their own.

Interventions

Mi Propio Camino (MPC)

The Mi Propio Camino (MPC) intervention will be comprised of four sessions. Session 1 will encompass: the facts about high blood pressure (BP), understanding blood pressure readings, provide an overview of changes one can make to manage their BP, introduce MPC personal experience monitoring, and usage the mHealth kit. Subsequently, sessions 2-4 will emphasize the benefits of personal experience monitoring through 1) personal insight (finding what works for them) and 2) empowerment to work with their providers. Session 2 will reinforce this by introducing: synergy between medication and lifestyle, principles of heart-healthy eating and physical activity. Session 3 will incorporate discussion of negative beliefs about medication and patient directed lifestyle learning-rotating stations. Lastly, session 4 will introduce the continuation of personal experience monitoring on their own through the use of behavioral strategies for adherence and provider communication strategies.

Intervention Type: BEHAVIORAL

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

The HCP intervention will be comprised of four sessions and introduce seven lifestyle strategies (LS) subdivided per these sessions. Session 1 will encompass the facts about high blood pressure (BP), understanding blood pressure readings, provide an overview of changes one can make to manage their BP, present specific health threats from high BP, and incorporate LS1: taking control of your medication. Subsequently, sessions 2-4 will reinforce the benefits of taking medications through presenting 1) reduced risk for complications and 2) strategies to remember to take medications. Session 2 will present LS2: eating a well-balanced, low-salt diet and LS3: enjoying regular physical activity. Session 3 will follow with introducing LS4: maintaining a healthy weight and LS5: shaking the salt habit while eating out. Session 4 will present LS6: managing stress and LS7: working together with their doctor followed by a review of strategies they can continue on their own.

Intervention Type: BEHAVIORAL

Other Intervention Names

MPC; HCP

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

John Thomas Billimek

Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Billimek, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Health Policy Research Institute

Irvine, California, United States

Countries

United States

Other Identifiers

1R01HL142964

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20174025

Identifier Type: -

Identifier Source: org_study_id