Trial Outcomes & Findings for Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence (NCT NCT04585594)

NCT ID: NCT04585594

Last Updated: 2026-02-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

511 participants

Primary outcome timeframe

6 months post-intervention

Results posted on

2026-02-24

Participant Flow

Participant milestones

Participant milestones
Measure
Mi Propio Camino (MPC; My Own Way)
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
Participants will complete the HCP intervention alongside usual care for hypertension.
Overall Study
STARTED
255
256
Overall Study
COMPLETED
143
161
Overall Study
NOT COMPLETED
112
95

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mi Propio Camino (MPC; My Own Way)
n=255 Participants
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
n=256 Participants
Participants will complete the HCP intervention alongside usual care for hypertension.
Total
n=511 Participants
Total of all reporting groups
Age, Continuous
56.5 years
STANDARD_DEVIATION 10.2 • n=58 Participants
54.7 years
STANDARD_DEVIATION 9.9
55.6 years
STANDARD_DEVIATION 10.1 • n=1 Participants
Sex: Female, Male
Female
167 Participants
n=58 Participants
181 Participants
348 Participants
n=1 Participants
Sex: Female, Male
Male
88 Participants
n=58 Participants
75 Participants
163 Participants
n=1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=58 Participants
0 Participants
1 Participants
n=1 Participants
Race (NIH/OMB)
Asian
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants
Race (NIH/OMB)
White
254 Participants
n=58 Participants
255 Participants
509 Participants
n=1 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=58 Participants
1 Participants
1 Participants
n=1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
255 Participants
n=58 Participants
256 Participants
511 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=58 Participants
0 Participants
0 Participants
n=1 Participants

PRIMARY outcome

Timeframe: 6 months post-intervention

Population: Participants with complete MEMS cap adherence data at 6-month follow-up were included in this analysis.

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.

Outcome measures

Outcome measures
Measure
Mi Propio Camino (MPC; My Own Way)
n=143 Participants
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
n=161 Participants
Participants will complete the HCP intervention alongside usual care for hypertension.
Medication Adherence (Objective)
54.9 Percent days adherent
Standard Deviation 38.7
64.2 Percent days adherent
Standard Deviation 37.1

SECONDARY outcome

Timeframe: 6 months post-intervention

Population: Participants with complete MMAS-8 data at 6-month follow-up were included in this analysis.

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.

Outcome measures

Outcome measures
Measure
Mi Propio Camino (MPC; My Own Way)
n=145 Participants
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
n=165 Participants
Participants will complete the HCP intervention alongside usual care for hypertension.
Medication Adherence (Subjective)
5.4 scale score
Standard Deviation 1.8
5.7 scale score
Standard Deviation 1.6

SECONDARY outcome

Timeframe: 6 months post-intervention

Population: Participants with complete Safran Medication Adherence questionnaire data at 6-month follow-up were included in this analysis

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.

Outcome measures

Outcome measures
Measure
Mi Propio Camino (MPC; My Own Way)
n=150 Participants
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
n=168 Participants
Participants will complete the HCP intervention alongside usual care for hypertension.
Number of Participants Who Were Nonadherent Due To Beliefs (Subjective)
62 Participants
71 Participants

SECONDARY outcome

Timeframe: 5 months post-intervention

Population: Participants with complete Beliefs about Medicines Questionnaire (BMQ) data at 5-month follow-up were included in this analysis

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).

Outcome measures

Outcome measures
Measure
Mi Propio Camino (MPC; My Own Way)
n=149 Participants
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
n=170 Participants
Participants will complete the HCP intervention alongside usual care for hypertension.
Medication-related Beliefs (Specific)
3.3 scale score
Standard Deviation 5.1
3.5 scale score
Standard Deviation 4.9

SECONDARY outcome

Timeframe: 6 months post-intervention

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

Outcome measures

Outcome measures
Measure
Mi Propio Camino (MPC; My Own Way)
n=121 Participants
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
n=133 Participants
Participants will complete the HCP intervention alongside usual care for hypertension.
Systolic Blood Pressure
137.2 mmHg
Standard Deviation 17.5
136.2 mmHg
Standard Deviation 18.6

SECONDARY outcome

Timeframe: 6 months post-intervention

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.

Outcome measures

Outcome measures
Measure
Mi Propio Camino (MPC; My Own Way)
n=121 Participants
Participants will complete the MPC intervention alongside usual care for hypertension
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
n=133 Participants
Participants will complete the HCP intervention alongside usual care for hypertension.
Diastolic Blood Pressure
83.1 mmHg
Standard Deviation 10.9
84.0 mmHg
Standard Deviation 12.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Knowledge of medication-related information will be assessed with a questionnaire adapted from the Medication Knowledge Questionnaire (MKQ)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Knowledge of Medication-related Behavioral Skills will be assessed withthe PROMIS Self-Efficacy for Managing Chronic Conditions Manage Medications/Treatment scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 measured with the Medication Adherence Strategies Inventory (ASI)60, an inventory of 7 common strategies for adherence.

Outcome measures

Outcome data not reported

Adverse Events

Mi Propio Camino (MPC; My Own Way)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Billimek

University of California, Irvine

Phone: 949-824-7677

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place