Clinical trial NCT04585594: Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence
Official title: Mi Propio Camino (Finding My Own Way): Personalized Approaches to Improve Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Medication Adherence
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-10-14
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 \[MEMS\]).

Eligibility criteria: 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.

Primary outcomes:
measure: Medication Adherence (Objective)
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Blood Pressure
timeFrame: Blood pressure will be 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.
measure: Medication Adherence (Subjective)
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.
measure: Reasons for Nonadherence
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.
measure: Medication-related beliefs (Specific)
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.
measure: Medication-related information
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.
measure: Medication-related Behavioral Skills
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.
measure: Activation of behavioral strategies
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.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Health Policy Research Institute
state: California
Study officials:
affiliation: University of California, Irvine
name: John Billimek, PhD
role: PRINCIPAL_INVESTIGATOR
References: