Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP) (BETTER-BP)
Primary Purpose
High Blood Pressure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Condition
Regret Lottery
Sponsored by
About this trial
This is an interventional treatment trial for High Blood Pressure
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of hypertension.
An active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ACE inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator).
- 1 ambulatory systolic blood pressure ≥140 mmHg (on therapy).
- Suboptimal adherence (self-report).
Exclusion Criteria:
- Incarcerated
- Pregnant
- Unable to use study software (Way To Health) in English or Spanish
- Unable/unwilling to consent
- Clear barrier to technology use (e.g. visual or hearing impairment)
- Projected life expectancy <12 months
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Regret lottery
Control Condition
Arm Description
Will receive a lottery incentive ("regret lottery") for 6 months
Will complete a total of 3 in-person study visits, approximately one hour each.
Outcomes
Primary Outcome Measures
Change in Systolic Blood Pressure (SBP)
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.
Adherence
Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform.
Secondary Outcome Measures
Full Information
NCT ID
NCT04114669
First Posted
September 20, 2019
Last Updated
April 24, 2023
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04114669
Brief Title
Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)
Acronym
BETTER-BP
Official Title
Behavioral Economics Trial To Enhance Regulation of Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) is a phase II, single-center, prospective, pragmatic randomized clinical trial within the New York City Health and Hospitals (NYC-H+H) system and NYU Langone Family Health Centers. The trial will recruit from 3 NYC-H+H ambulatory clinics as well as NYU Langone Family Health Centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. The trial will randomize 435 patients with hypertension determined to have poor adherence (<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. Baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
435 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regret lottery
Arm Type
Experimental
Arm Description
Will receive a lottery incentive ("regret lottery") for 6 months
Arm Title
Control Condition
Arm Type
Placebo Comparator
Arm Description
Will complete a total of 3 in-person study visits, approximately one hour each.
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Regret Lottery
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure (SBP)
Description
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.
Time Frame
baseline to 12 Months
Title
Adherence
Description
Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform.
Time Frame
12 Months
Other Pre-specified Outcome Measures:
Title
Motivation measured with the Treatment Self-Regulation Questionnaire (TSRQ)
Time Frame
Baseline, 6 months, and 12 months
Title
Self-efficacy measured by the Medication Adherence Self Efficacy Scale (MASES)
Description
a 26-item scale used to assess patients' confidence in their ability to take Antihypertensive medications. Items are scored from 1 (not at all sure) to 4 (extremely sure) and a total score on the measure is computed by averaging across responses to all items. Higher scores indicate a greater level of self-efficacy. MASES will be administered at baseline, 6 months, and 12 months to evaluate change over time.
Time Frame
12 Months
Title
Comorbidity burden will be evaluated (baseline) using the Charlson Comorbidity Index (CCI)
Description
weighted index that includes 19 chronic medical conditions, each of which is weighted on a scale of 1-6
Time Frame
Baseline
Title
Depression will be measured (baseline) by the PHQ-9
Description
a validated screening tool consisting of 9 symptom questions that are scored on a scale of 0 ("not at all") to 3 ("nearly every day"). A score of ≥10 is consistent with at least moderate depression.
Time Frame
12 Months
Title
Patient-reported health status will be measured (baseline) using the Short Form 12 (SF-12).
Description
Physical (PCS) and Mental (MCS) Component Summary scores based on SF-12 responses will be calculated automatically using a proprietary algorithm (Optum Labs, Eden Prairie, MN), with higher scores indicating better health.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of hypertension.
An active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ACE inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator).
1 ambulatory systolic blood pressure ≥140 mmHg (on therapy).
Suboptimal adherence (self-report).
Exclusion Criteria:
Incarcerated
Pregnant
Unable to use study software (Way To Health) in English or Spanish
Unable/unwilling to consent
Clear barrier to technology use (e.g. visual or hearing impairment)
Projected life expectancy <12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Pena, MA
Phone
646-951-6796
Email
BETTER-BP@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lysy Gonzalez
Phone
646-501-2646
Email
BETTER-BP@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Dodson
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lysy Gonzalez
Phone
646-501-2646
Email
BETTER-BP@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Andrea Pena
Phone
646-951-6796
Email
BETTER-BP@nyulangone.org
First Name & Middle Initial & Last Name & Degree
John Dodson, MD
12. IPD Sharing Statement
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Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)
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