HypertensionMPCNCT04585594
Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence
A study testing Mi Propio Camino (MPC) in people with Hypertension and Medication Adherence, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Medication Adherence
- What is being tested?
- Mi Propio Camino (MPC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2020to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Health Policy Research Institute
Irvine, California, 92697
About this study
Official 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.
Read the 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
- Being tested
- Mi Propio Camino (MPC), Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mi Propio Camino (MPC)Behavioural
Also called 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.
Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)Behavioural
Also called HCP
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.
| Study group | Role | What they receive |
|---|---|---|
| Mi Propio Camino (MPC; My Own Way) | Experimental | Participants will complete the MPC intervention alongside usual care for hypertension Receives: 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. Receives: Behavioral: Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-intervention
Secondary outcomes (5)
Medication Adherence (Subjective)
Subjective medication adherence was assessed with a validated Spanish-language version of the Morisky Medication Adherence Scale (8-item MMAS; score range 0-8 with higher scores corresponding to better adherence). Scores were analyzed as a continuous scale score at 6-month follow-up.
Measured: 6 months post-intervention
Number of Participants Who Were Nonadherent Due To Beliefs (Subjective)
Nonadherence related to beliefs was assessed with the Safran Medication Adherence questionnaire, and defined as endorsement of one or more of 6 belief-related nonadherence items in the questionnaire at 6-month follow-up.
Measured: 6 months post-intervention
Medication-related Beliefs (Specific)
Medication-related beliefs were assessed using the Beliefs about Medicines Questionnaire - Specific Necessity-Concerns scale (range -20 - +20), with higher scores indicating more positive beliefs about one's prescribed blood pressure medications (i.e. greater perceived necessity relative to concerns).
Measured: 5 months post-intervention
Systolic 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
Measured: 6 months post-intervention
Diastolic 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.
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start16 Sep 2020
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, John Thomas Billimek, University of California, Irvine
- Investigators
- John Billimek, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585594
- Sponsor's protocol ID
- 20174025
- Other IDs
- 1R01HL142964
- Acronym
- MPC
- Status last verified
- Feb 2026
- First submitted
- 6 Oct 2020
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mi Propio Camino (Finding My Own Way): Personalized Approaches to Improve Blood Pressure Control
- ClinicalTrials.gov ID
- NCT04585594
- Acronym / sponsor ID
- MPC / 20174025
- Conditions
- Hypertension, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mi Propio Camino (MPC; My Own Way) | Experimental | Behavioral: 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) | Active comparator | Behavioral: Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)Participants will complete the HCP intervention alongside usual care for hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mi Propio Camino (MPC)Also: MPCThe 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. | Behavioural | Mi Propio Camino (MPC; My Own Way) |
| Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)Also: HCPThe 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. | Behavioural | Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control) |
Primary outcome
Medication Adherence (Objective)
Time frame: 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.
5 secondary outcomes
Medication Adherence (Subjective)
Time frame: 6 months post-intervention
Number of Participants Who Were Nonadherent Due To Beliefs (Subjective)
Time frame: 6 months post-intervention
Medication-related Beliefs (Specific)
Time frame: 5 months post-intervention
Systolic Blood Pressure
Time frame: 6 months post-intervention
Diastolic Blood Pressure
Time frame: 6 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Billimek, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mi Propio Camino (MPC) in people with Hypertension and Medication Adherence, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (Objective) (time frame: 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.