Trial Outcomes & Findings for Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP) (NCT NCT04114669)
NCT ID: NCT04114669
Last Updated: 2026-05-27
Results Overview
Three seated BPs will be measured after a rest period (5 minutes) using an automated device (Omron, Lake Forest, IL) which will reduce the potential for observer bias. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
401 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2026-05-27
Participant Flow
Participant milestones
| Measure |
Regret Lottery
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
265
|
135
|
|
Overall Study
COMPLETED
|
235
|
109
|
|
Overall Study
NOT COMPLETED
|
30
|
26
|
Reasons for withdrawal
| Measure |
Regret Lottery
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
22
|
23
|
Baseline Characteristics
Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)
Baseline characteristics by cohort
| Measure |
Regret Lottery
n=265 Participants
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
n=135 Participants
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=51 Participants
|
56 years
n=14 Participants
|
57 years
n=65 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=51 Participants
|
85 Participants
n=14 Participants
|
242 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=51 Participants
|
50 Participants
n=14 Participants
|
158 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
163 Participants
n=51 Participants
|
83 Participants
n=14 Participants
|
246 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=51 Participants
|
52 Participants
n=14 Participants
|
154 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
11 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=51 Participants
|
20 Participants
n=14 Participants
|
81 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
13 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
26 Participants
n=51 Participants
|
23 Participants
n=14 Participants
|
49 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
163 Participants
n=51 Participants
|
83 Participants
n=14 Participants
|
246 Participants
n=65 Participants
|
|
Region of Enrollment
United States
|
265 participants
n=51 Participants
|
135 participants
n=14 Participants
|
400 participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Three seated BPs will be measured after a rest period (5 minutes) using an automated device (Omron, Lake Forest, IL) which will reduce the potential for observer bias. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period.
Outcome measures
| Measure |
Regret Lottery
n=265 Participants
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
n=135 Participants
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
|
-6.7 mmHg
Interval -8.9 to -4.4
|
-5.8 mmHg
Interval -9.1 to -2.4
|
PRIMARY outcome
Timeframe: Month 6, Month 12Three seated BPs will be measured after a rest period (5 minutes) using an automated device (Omron, Lake Forest, IL) which will reduce the potential for observer bias. The average of the three measurements will be recorded as the value for that time period. The change is the difference in mean measurements during each time period.
Outcome measures
| Measure |
Regret Lottery
n=265 Participants
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
n=135 Participants
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
|
-0.2 mmHg
Interval -3.9 to 3.5
|
3.6 mmHg
Interval -1.8 to 8.9
|
SECONDARY outcome
Timeframe: Baseline, Month 6Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period.
Outcome measures
| Measure |
Regret Lottery
n=265 Participants
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
n=135 Participants
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
Percentage of Participants With Adequate Antihypertensive Adherence
|
71 Percentage of participants
|
34 Percentage of participants
|
SECONDARY outcome
Timeframe: Month 12Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform. Adequate adherence defined as ≥ 80% of days adherent from baseline to 6 months. Adherence was calculated using the scheduling adherence metric, which is the proportion of days that a participant took their prescribed medication divided by the total number of days that they were expected to take medication in a given period.
Outcome measures
| Measure |
Regret Lottery
n=261 Participants
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
n=134 Participants
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
Percentage of Participants With Adequate Antihypertensive Adherence
|
31 Percentage of participants
|
26 Percentage of participants
|
Adverse Events
Regret Lottery
Serious events: 30 serious events
Other events: 60 other events
Deaths: 2 deaths
Control Condition
Serious events: 14 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regret Lottery
n=265 participants at risk
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
n=135 participants at risk
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
General disorders
Syncope
|
1.1%
3/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.74%
1/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
Renal and urinary disorders
Renal/Electrolyte Abnormality
|
1.1%
3/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
1.5%
2/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Fall Related Injuries
|
1.1%
3/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.00%
0/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Abdominal Pain
|
0.38%
1/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
1.5%
2/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Chest Pain
|
0.75%
2/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.74%
1/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
Surgical and medical procedures
Elective Surgery
|
1.1%
3/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.74%
1/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Pancreatitis
|
0.75%
2/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.00%
0/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Pulmonary Embolism
|
0.75%
2/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.74%
1/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Other
|
4.2%
11/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
4.4%
6/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
Other adverse events
| Measure |
Regret Lottery
n=265 participants at risk
Will receive a lottery incentive ("regret lottery") for 6 months
Regret Lottery: Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won ("regret" component).
|
Control Condition
n=135 participants at risk
Will complete a total of 3 in-person study visits, approximately one hour each.
Control Condition: 3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.75%
2/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.00%
0/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
Cardiac disorders
Hypotension
|
7.2%
19/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
4.4%
6/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
Renal and urinary disorders
Renal/Electrolyte Abnormality
|
9.8%
26/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
10.4%
14/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Fall Related Injuries
|
3.4%
9/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.00%
0/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
|
General disorders
Syncope
|
1.5%
4/265 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
0.74%
1/135 • 12 months.
Collection approach was systematic. The Research Coordinator monitored AEs/SAEs monthly and met with site investigator monthly so that the site investigator can classify and categorize AE/SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place