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Medication Adherence Problem Solving for High Blood Pressure (MASH Trial)
N/A
Recruiting
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
Aged ≥ 18 years at time of study entry
Diagnosis of HTN, based on self-report or confirmed through medical records, where available (Self-reported high BP has long been shown to be strongly correlated with presence of a HTN diagnosis. Self-report combined with presence of a prescribed HTN medication ensures that only participants with HTN will be included)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
MASH Trial 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.Check my eligibility
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.See study design
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.
MASH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with high blood pressure.
MASH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participant engagement
Participant retention
Patient satisfaction with intervention
+1 moreSecondary outcome measures
Antihypertensive medication adherence
Blood pressure
MASH 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.
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
420 Previous Clinical Trials
163,209 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for participants currently available in this experiment?
"According to clinicaltrials.gov, this trial is not currently recruiting participants. Initially posted on January 1st 2023 and last updated November 18th 2022, it is one of 816 other trials actively searching for potential candidates at the present time."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Rush University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
No medicine is working.
PatientReceived no prior treatments
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