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
|Condition or disease||Intervention/treatment||Phase|
|High Blood Pressure||Behavioral: Control Condition Behavioral: Regret Lottery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||435 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|Contact: Andrea Pena, MA||646-951-6796||Andrea.Pena@nyulangone.org|
|Contact: Lysy Gonzalezfirstname.lastname@example.org|
|United States, New York|
|NYU Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: Lysy Gonzalez 646-501-2646|
|Contact: Andrea Pena 646-951-6796 Andrea.Pena@nyulangone.org|
|Principal Investigator: John Dodson, MD|
|Principal Investigator:||John Dodson||New York Langone Health|