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Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP) (BETTER-BP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114669
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
NYU Langone Health

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. The trial will recruit from 3 NYC-H+H ambulatory clinics, 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.

Condition or disease Intervention/treatment Phase
High Blood Pressure Behavioral: Control Condition Behavioral: Regret Lottery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Economics Trial To Enhance Regulation of Blood Pressure
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Regret lottery
Will receive a lottery incentive ("regret lottery") for 6 months
Behavioral: 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).

Placebo Comparator: Control Condition
Will complete a total of 3 in-person study visits, approximately one hour each.
Behavioral: Control Condition
3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.




Primary Outcome Measures :
  1. Change in Systolic Blood Pressure (SBP) [ Time Frame: baseline to 12 Months ]
    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.

  2. Adherence [ Time Frame: 12 Months ]
    Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform.


Other Outcome Measures:
  1. Motivation measured with the Treatment Self-Regulation Questionnaire (TSRQ) [ Time Frame: Baseline, 6 months, and 12 months ]
  2. Self-efficacy measured by the Medication Adherence Self Efficacy Scale (MASES) [ Time Frame: 12 Months ]
    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.

  3. Comorbidity burden will be evaluated (baseline) using the Charlson Comorbidity Index (CCI) [ Time Frame: Baseline ]
    weighted index that includes 19 chronic medical conditions, each of which is weighted on a scale of 1-6

  4. Depression will be measured (baseline) by the PHQ-9 [ Time Frame: 12 Months ]
    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.

  5. Patient-reported health status will be measured (baseline) using the Short Form 12 (SF-12). [ Time Frame: 12 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114669


Contacts
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Contact: Lysy Gonzalez (646) 501-2646 lysy.gonzalez@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Lysy Gonzalez    646-501-2646      
Principal Investigator: John Dodson, MD         
Sponsors and Collaborators
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: John Dodson New York Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04114669    
Other Study ID Numbers: 19-00952
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases