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

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ClinicalTrials.gov Identifier: NCT04114669
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE September 20, 2019
First Posted Date  ICMJE October 3, 2019
Last Update Posted Date December 7, 2020
Actual Study Start Date  ICMJE July 14, 2020
Estimated Primary Completion Date March 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
  • 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.
  • Adherence [ Time Frame: 12 Months ]
    Measured with a wireless Tech wireless which transfers data via cell phone to the Way to Health platform.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 1, 2019)
  • Motivation measured with the Treatment Self-Regulation Questionnaire (TSRQ) [ Time Frame: Baseline, 6 months, and 12 months ]
  • 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.
  • 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
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)
Official Title  ICMJE Behavioral Economics Trial To Enhance Regulation of Blood Pressure
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE High Blood Pressure
Intervention  ICMJE
  • Behavioral: Control Condition
    3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 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).
Study Arms  ICMJE
  • Experimental: Regret lottery
    Will receive a lottery incentive ("regret lottery") for 6 months
    Intervention: Behavioral: Regret Lottery
  • Placebo Comparator: Control Condition
    Will complete a total of 3 in-person study visits, approximately one hour each.
    Intervention: Behavioral: Control Condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2019)
435
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2024
Estimated Primary Completion Date March 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Pena, MA 646-951-6796 Andrea.Pena@nyulangone.org
Contact: Lysy Gonzalez 646-501-2646 lysy.gonzalez@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04114669
Other Study ID Numbers  ICMJE 19-00952
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: John Dodson New York Langone Health
PRS Account NYU Langone Health
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP