Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence

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• Hypertension 6,690
• Medication Adherence 223

Hypertension

6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.

This study's enrollment of 511 is above the median of 90 across 4,996 interventional studies indexed under Hypertension.

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Mi Propio Camino (MPC; My Own Way)

  Participants will complete the MPC intervention alongside usual care for hypertension

  Behavioral: Mi Propio Camino (MPC)

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

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

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

Interventions

• BehavioralMi Propio Camino (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.

  Also known as: MPC

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

  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

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.

   Time frame: 6 months post-intervention

Secondary outcomes

1. 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.

   Time frame: 6 months post-intervention

2. 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.

   Time frame: 6 months post-intervention

3. 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).

   Time frame: 5 months post-intervention

4. 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

   Time frame: 6 months post-intervention

5. 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.

   Time frame: 6 months post-intervention

Other outcomes

1. Medication-related Information

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

   Time frame: 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.

2. 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

   Time frame: 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.

3. 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.

   Time frame: 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.

Baseline characteristics

Study documents

• Study protocol · Feb 3, 2023
• Statistical analysis plan · Jan 17, 2026

Documents are hosted by the registry — open the source record to download them.