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Home Blood Pressure Monitoring Methods for High Blood Pressure (CHANGE-BP Trial)
N/A
Waitlist Available
Led By Aaron Shoenkerman, MD
Research Sponsored by Aktiia SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 21-80 years old
Fluent in written and spoken English as the technology is currently only available in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months
Awards & highlights
CHANGE-BP Trial Summary
This trial compares 2 methods of BP monitoring over 6 months to see which is more effective.
Who is the study for?
This trial is for adults aged 21-80 with high blood pressure, who are patients of Providence Health, own a smartphone with data plan, and can attend two in-person visits. They must not have severe kidney disease, certain heart conditions or be on specific treatments that affect blood pressure.Check my eligibility
What is being tested?
The CHANGE-BP study compares continual monitoring using the Aktiia cuffless BP system and app against routine home monitoring with a standard arm cuff. The goal is to see which method better manages high blood pressure over six months.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the devices or skin irritation due to materials like silicone in the Aktiia bracelet. However, these devices are generally considered safe and non-invasive.
CHANGE-BP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 80 years old.
Select...
I am fluent in both written and spoken English.
Select...
I am willing to go to 2 in-person study visits.
CHANGE-BP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in blood pressure
Secondary outcome measures
Participant compliance
Participant engagement
Participant perception
+1 moreCHANGE-BP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Blood Pressure Monitoring (CBPM)Experimental Treatment1 Intervention
Participants will wear the Aktiia Bracelet for 6-months and potentially receive blood pressure medication titrations during the 6-month period.
Group II: Home Blood Pressure Monitoring (HBPM)Active Control1 Intervention
Participants will receive an upper arm cuff and standard hypertension care from their primary care physician.
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Who is running the clinical trial?
Aktiia SALead Sponsor
7 Previous Clinical Trials
5,584 Total Patients Enrolled
Aaron Shoenkerman, MDPrincipal InvestigatorProvidence Health & Services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving or will receive chemotherapy through IV.Your heart beats very fast even when you are not active.My heart's pumping ability is significantly reduced.You have an abnormal connection between an artery and a vein.I am between 21 and 80 years old.I have a skin condition that causes peeling or scaling.I have a narrowed subclavian artery.I am fluent in both written and spoken English.I experience trembling and shivering.I am willing to go to 2 in-person study visits.I have had an arm amputated.You had a bone mineral density test in the last 12 months, or are willing to get one if the clinical pharmacist thinks it's necessary.I have ongoing or long-term atrial fibrillation.I have been diagnosed with pheochromocytoma.Your upper arm is too small or too big for this study.My doctor expects I have less than 2 years to live due to my condition.My kidney function is severely reduced.You have an allergy to silicone.I have myxedema coma.I have Raynaud's disease.I am currently being treated for an overactive thyroid.I have swelling in my arms or legs due to lymph fluid buildup.Your wrist size is smaller than 14 cm or larger than 21 cm.I need someone legally authorized to make medical decisions for me.You have been diagnosed with white coat hypertension.You are currently on hospice care or will be going on hospice care within the next 6 months.I have diabetes.Your blood pressure has been consistently high, or it was high during your last doctor's visit.I am willing to be assigned to any treatment group by chance.Is a patient receiving care from Providence Health.Your blood pressure at the start of the study is either too low or too high.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Blood Pressure Monitoring (CBPM)
- Group 2: Home Blood Pressure Monitoring (HBPM)
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: NCT05746117 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are those above the age of forty capable of participating in this research endeavor?
"The eligibility criteria for this medical study restricts the age of participants to between 21 and 80 years old. By comparison, those under 18 have 53 trials available while there are 664 options for seniors over 65."
Answered by AI
What criteria must be met for a participant to qualify for this trial?
"This clinical trial has set parameters of acceptable enrolment; patients must have hypertension, fall within the 21 to 80 age range, and number around 500."
Answered by AI
Is this experiment currently enrolling participants?
"This clinical trial, which was first advertised on March 15th 2023 and last updated on February 17th 2023, is not currently looking for new participants. However, the portals hosted by clinicaltrials.gov list 741 other medical studies that are actively recruiting patients at this moment in time."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am on 3 different medications to lower blood pressure. The pressure is erratic depending on time of day it is measured. Ranges from 110/45 to 154/75. Interested in the Aktiia device to try to determine a pattern based on diet and/or lifestyle.
PatientReceived no prior treatments
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