Your session is about to expire
← Back to Search
Medication Adherence Problem Solving for High Blood Pressure (MASH Trial)
N/A
Waitlist Available
Led By Todd Ruppar, PhD, RN
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a telehealth program to help people take their blood pressure meds and reduce the risk of heart disease. #medicine #telehealth
Who is the study for?
This trial is for adults with high blood pressure who struggle to stick to their medication routine, have a systolic BP ≥ 130 mmHg or diastolic BP ≥ 80 mmHg, and can read and speak English. They must be on stable blood pressure medication for at least 30 days prior. Those in hypertensive crisis, with terminal illness, end-stage renal disease, or acute illness are excluded.
What is being tested?
The study is testing a telehealth program designed to help patients better follow their high blood pressure medication schedules. It's tailored to individual needs and aims to improve overall blood pressure control through enhanced adherence.
What are the potential side effects?
Since the intervention involves counseling rather than drugs, there may not be direct side effects like those associated with medications; however, participants might experience stress or anxiety related to changes in their medication-taking routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participant engagement
Participant retention
Patient satisfaction with intervention
+1 moreSecondary study objectives
Antihypertensive medication adherence
Blood pressure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth Intervention GroupExperimental Treatment1 Intervention
The intervention components are: 1) educational modules and 2) bi-weekly telehealth visits for managed problem solving for 12 weeks.
All intervention participants will be provided four educational modules, electronically and in print form. The modules are adapted from evidence-based materials developed by the American Heart Association, American College of Cardiology, and Centers for Disease Control and Prevention and cover (1) the causes of HTN, (2) how HTN raises risks for other chronic conditions, (3) medications for effectively managing high BP, and (4) how to manage barriers to medication adherence.
Telehealth visits will supplement and reinforce the educational modules, addressing participants' specific knowledge needs and enhancing self-efficacy.
Group II: ControlActive Control1 Intervention
The study will use a usual-care control group. The standard of care for this patient population does not involve any type of medication adherence intervention or monitoring beyond regular clinic follow-up visits with their health care provider. Control group participants will be given printed handouts on the American Heart Association's Life's Simple 7 lifestyle changes for reducing cardiovascular risk, along with the instructions for using the MEMS cap. If control group participants ask about their antihypertensive medications during the study, they will be referred to their prescribing provider or pharmacist for any information that could not be obtained from the medication label or pharmacy packaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medication Adherence Problem Solving for Hypertension
2023
N/A
~40
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
249,212 Total Patients Enrolled
Todd Ruppar, PhD, RNPrincipal InvestigatorRush University Medical Center
1 Previous Clinical Trials
43 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have insurance or assistance that covers my medication costs.I am not currently experiencing severe symptoms like heart attack, breathing problems, or stroke.I am 18 years old or older.My blood pressure is extremely high, over 180/120 mmHg.My doctor says I have 6 months or less to live due to a chronic illness.I have been on the same blood pressure medication for at least 30 days.I have been diagnosed with high blood pressure.I have end-stage kidney disease or am on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Telehealth Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Blood Pressure Patient Testimony for trial: Trial Name: NCT05630521 — N/A