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.
COMPLETED
NA
511 participants
6 months post-intervention
2026-02-24
Participant Flow
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
| 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-interventionPopulation: 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
| 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-interventionPopulation: 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
| 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-interventionPopulation: 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
| 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-interventionPopulation: 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
| 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-interventionThis 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
| 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-interventionThis 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
| 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)
Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place