Clinical Trials Directory

Trials / Completed

CompletedNCT05630521

Testing Feasibility of Medication Adherence Problem Solving for Hypertension

Testing Feasibility of the Medication Adherence Problem Solving for Hypertension (MASH) Intervention to Improve Antihypertensive Medication Adherence

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Rush University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Adherence to medications for high blood pressure is key to improving blood pressure control and reducing the impact of cardiovascular disease. This project will test the feasibility of a tailored telehealth intervention to help patients improve adherence to blood pressure medication.

Detailed description

Improving rates of blood pressure (BP) control among adults with hypertension is a key step in reducing rates of myocardial infarction, stroke, and heart failure, and lowering overall mortality from cardiovascular disease. Unfortunately, over half of patients prescribed medication for hypertension do not take their medication as prescribed, leading to a high percentage of patients (45%) who are unable to reach their target BP despite being treated with antihypertensive medication. Low medication adherence has been linked with higher rates of myocardial infarction, stroke, and angina, as well as reduced life expectancy. Previously tested interventions to improve adherence to antihypertensive regimens have had limited efficacy, largely due to an underlying assumption that a single, standardized intervention approach will address all patients' reasons for nonadherence. Tailoring adherence interventions using a Managed Problem Solving approach will permit addressing each patient's reasons for nonadherence. This project will test the feasibility of the Medication Adherence Problem Solving for Hypertension (MASH) telehealth intervention, tailored to each participant's reasons for low adherence to their antihypertensive medication. The intervention is designed to assess beliefs about hypertension, beliefs about medications, and barriers to effective medication-taking We will then deliver intervention strategies to address each patient's problematic beliefs and barriers, applying the 5 steps of Managed Problem Solving. The proposed project aims are to 1) Assess the feasibility of MASH to improve antihypertensive medication adherence among adults with hypertension (HTN) by tracking recruitment, participant engagement and satisfaction with the intervention, as well as retention in the study; 2) Obtain estimates of efficacy of MASH compared to usual care on improving antihypertensive adherence as measured by electronic monitoring caps (MEMS) and lowering BP among persons with elevated BP at baseline over 12 weeks to inform future power analyses for a full-scale trial; and 3) Obtain estimates of other model parameters necessary to inform future power analyses for a full-scale intervention trial, including (a) intervention effects on targeted reasons for nonadherence (beliefs, barriers, perceived side-effects) and their subsequent association with medication adherence; (b) strength of covariate effects (e.g. education, household size, employment); and (c) the within-participant correlation between assessments. If successful, this intervention can also serve as a model for improving medication adherence in other chronic conditions and improve health outcomes for the half of patients with chronic conditions who struggle to manage their medications.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMedication Adherence Problem Solving for HypertensionThe MASH program is a 12-week intervention containing two components: (1) four education modules on HTN causes, risks, treatment, and barriers to treatment; and (2) telehealth visits every 2 weeks with a registered nurse to deliver evidence-based managed problem solving strategies tailored on patients' responses to assessments of HTN beliefs, medication beliefs, and barriers impacting their medication adherence.

Timeline

Start date
2023-02-20
Primary completion
2024-08-25
Completion
2024-09-25
First posted
2022-11-29
Last updated
2024-10-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05630521. Inclusion in this directory is not an endorsement.