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Behavioral Economic Interventions for High Blood Pressure (BETA Trial)
N/A
Waitlist Available
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
On anti-hypertensive medication (AH)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 9 months
Awards & highlights
BETA Trial Summary
This trial aims to improve medication adherence for hypertensive patients by using insights from behavioral economics.
Who is the study for?
This trial is for adults over 18 with high blood pressure who are on medication but may struggle to take it consistently. They must have access to a phone most days and be open to receiving text messages. Those under 18, not cleared by their doctor, unwilling to use special pill bottle caps, unable to consent, or in another similar study can't join.Check my eligibility
What is being tested?
The study tests if a behavioral economics approach can help patients stick to their blood pressure medication routine better. It involves incentives tied to daily habits ('anchoring') and regular reminders through text messages.See study design
What are the potential side effects?
Since the interventions involve non-medical strategies (incentives and texts), there are no direct medical side effects from participating in this trial; however, participants may experience changes in behavior or adherence patterns.
BETA 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 am taking medication for high blood pressure.
BETA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months and 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electronically Measured Mean Medication Adherence During Intervention
Electronically Measured Mean Medication Adherence Post Intervention
Routinization of AH Adherence Post-intervention
Secondary outcome measures
Hypertension Control
BETA Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Incentive GroupExperimental Treatment2 Interventions
The Incentive group will receive the same information and text messages, but in addition have a chance of winning small, intermittent rewards for taking their medication at the time coinciding with their anchoring strategy. In this group, participants will be eligible for a prize drawing if they take their medication within +/- 1 hour of the time they carry out their existing routine behavior on at least 80% of days between clinic visits. When the participants return for their monthly visit, the study coordinator will download their MEMS-cap data and check whether this eligibility criteria was satisfied. MEMS software can be easily customized to display this information. If the patient qualifies, s/he is invited to draw one of three laminated cards with numbers 0, 25, and 50 out of a bag. The client receives the corresponding amount in USD in the form of a gift card immediately after the drawing.
Group II: Message GroupActive Control1 Intervention
The Message group will receive the same brief information session as the Control group but also receive daily text messages reinforcing the information provided for 3 months. A key insight from BE is that people typically are initially highly motivated to change their behavior, but their enthusiasm declines over time. To keep the importance of routinizing pill- taking salient (i.e. high on a person's mental priority list), we will send daily text messages using a freely available web platform. These messages will reinforce the information provided at recruitment, and remind participants of their personalized routinization strategy. Messages will be tailored and refreshed based on patient-specific factors including BP control, prior adherence, and current medication regimen.
Group III: Control GroupActive Control1 Intervention
The Control group will receive care as usual, as well as a MEMS-cap and a leaflet explaining the importance of pill-taking routines and how to establish them. The study coordinator will spend approximately ten minutes with them to go over the leaflet and answer questions. Control group participants also spend time with the study coordinator at each clinic visit where contact information is updated, and any MEMS-cap problems are resolved. These procedures, which we successfully applied in previous studies, minimize the possibility that results are confounded by differences in attention or other non-specific effects between groups.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Text Message
2011
Completed Phase 1
~35920
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,436 Total Patients Enrolled
Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,797 Total Patients Enrolled
RANDOTHER
137 Previous Clinical Trials
510,191 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment for this experiment still open?
"This research initiative, which was initially launched on April 19th 2022 and last updated on October 7th of the same year is no longer recruiting participants. Nevertheless, 816 other clinical trials are currently active in their search for volunteers."
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