Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence

NCT04585594 | Completed Results

• 2 other identifiers: 201740251R01HL142964
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Medication Adherence (Subjective)

  6 months post-intervention

• Number of Participants Who Were Nonadherent Due To Beliefs (Subjective)

  6 months post-intervention

• Medication-related Beliefs (Specific)

  5 months post-intervention

• Systolic Blood Pressure

  6 months post-intervention

• Diastolic Blood Pressure

  6 months post-intervention

Other Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Mi Propio Camino (MPC; My Own Way)

EXPERIMENTAL

Participants will complete the MPC intervention alongside usual care for hypertension

Behavioral: Mi Propio Camino (MPC)

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

ACTIVE COMPARATOR

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

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

Interventions

Mi Propio Camino (MPC) 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.

Also known as: MPC

Mi Propio Camino (MPC; My Own Way)

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

Also known as: HCP

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of California, Irvine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Health Policy Research Institute

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Objective adherence was measured using MEMS caps, which record bottle-opening events and may not perfectly correspond to ingestion; this limitation is inherent to all electronic monitoring approaches.

Results Point of Contact

• Title: John Billimek
• Organization: University of California, Irvine

jbillime@uci.edu

949-824-7677

Study Officials

• John Billimek, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: September 16, 2020
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Locations

US (1)