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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL142964 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mi Propio Camino (MPC; My Own Way) | Experimental | Participants will complete the MPC intervention alongside usual care for hypertension |
|
| Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control) | Active Comparator | Participants will complete the HCP intervention alongside usual care for hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Medication-related Information | Knowledge of medication-related information will be assessed with a questionnaire adapted from the Medication Knowledge Questionnaire (MKQ) | 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. |
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.
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| Name | Affiliation | Role |
|---|---|---|
| John Billimek, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Policy Research Institute | Irvine | California | 92697 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mi Propio Camino (MPC; My Own Way) | Participants will complete the MPC intervention alongside usual care for hypertension |
| FG001 | Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control) | Participants will complete the HCP intervention alongside usual care for hypertension. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mi Propio Camino (MPC; My Own Way) | Participants will complete the MPC intervention alongside usual care for hypertension |
| BG001 | Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at study enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with complete MEMS cap adherence data at 6-month follow-up were included in this analysis. | Posted | Mean | Standard Deviation | Percent days adherent | 6 months post-intervention |
|
From randomization through completion of 6-month post-intervention follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mi Propio Camino (MPC; My Own Way) | Participants will complete the MPC intervention alongside usual care for hypertension |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Billimek | University of California, Irvine | 949-824-7677 | jbillime@uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2023 | Jan 17, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2026 | Jan 17, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| 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. |
|
|
| 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. | 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). | 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 | 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. | 6 months post-intervention |
| Medication-related Behavioral Skills |
Knowledge of Medication-related Behavioral Skills will be assessed withthe PROMIS Self-Efficacy for Managing Chronic Conditions Manage Medications/Treatment scale |
| 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 | Activation of behavioral strategies measured with the Medication Adherence Strategies Inventory (ASI)60, an inventory of 7 common strategies for adherence. | 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. |
Participants will complete the HCP intervention alongside usual care for hypertension.
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Self reported sex | Count of Participants | Participants |
|
| Race (NIH/OMB) | Participant reported race | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Participant reported ethnicity | Count of Participants | Participants |
|
| OG001 | Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control) | Participants will complete the HCP intervention alongside usual care for hypertension. |
|
|
| Secondary | 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. | Participants with complete MMAS-8 data at 6-month follow-up were included in this analysis. | Posted | Mean | Standard Deviation | scale score | 6 months post-intervention |
|
|
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| Secondary | 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. | Participants with complete Safran Medication Adherence questionnaire data at 6-month follow-up were included in this analysis | Posted | Count of Participants | Participants | 6 months post-intervention |
|
|
|
| Secondary | 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). | Participants with complete Beliefs about Medicines Questionnaire (BMQ) data at 5-month follow-up were included in this analysis | Posted | Mean | Standard Deviation | scale score | 5 months post-intervention |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mmHg | 6 months post-intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | 6 months post-intervention |
|
|
|
| Other Pre-specified | Medication-related Information | Knowledge of medication-related information will be assessed with a questionnaire adapted from the Medication Knowledge Questionnaire (MKQ) | Not Posted | Mean | Standard Deviation | Percent days adherent | 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. | Participants |
| Other Pre-specified | Medication-related Behavioral Skills | Knowledge of Medication-related Behavioral Skills will be assessed withthe PROMIS Self-Efficacy for Managing Chronic Conditions Manage Medications/Treatment scale | Not Posted | Mean | Standard Deviation | Percent days adherent | 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. | Participants |
| Other Pre-specified | Activation of Behavioral Strategies | Activation of behavioral strategies measured with the Medication Adherence Strategies Inventory (ASI)60, an inventory of 7 common strategies for adherence. | Not Posted | Mean | Standard Deviation | Percent days adherent | 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. | Participants |
| 0 |
| 255 |
| 0 |
| 255 |
| 0 |
| 255 |
| EG001 | Habilidades Para Controlar la Presion (HCP; Skills for Blood Pressure Control) | Participants will complete the HCP intervention alongside usual care for hypertension. | 0 | 256 | 0 | 256 | 0 | 256 |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |