Building Engagement Using Financial Incentives Trial - Hypertension
- Conditions
- HypertensionHealthcare Patient AcceptancePatient EngagementHealth BehaviorAdherence, Patient
- Interventions
- Behavioral: Remote Patient MonitoringBehavioral: Self-monitoring of hypertension-related factorsBehavioral: Immediate financial incentivesBehavioral: Delayed financial incentives
- Registration Number
- NCT06195839
- Lead Sponsor
- Tulane University
- Brief Summary
The goal of this pilot clinical trial is to determine feasibility and explore whether immediate versus delayed patient financial incentives improve patient engagement with self-monitoring of blood pressure in patients with uncontrolled hypertension at Louisiana federally qualified health centers (FQHCs). The main questions it aims to answer are:
* Do patients randomized to receive financial incentives on a weekly basis during the study (immediate) have better adherence to blood pressure self-monitoring compared to patients randomized to receive financial incentives at the end of the study (delayed)?
* Do patients randomized to immediate financial incentives have better blood pressure control compared to patients randomized to delayed incentives?
Participants will:
* attend a baseline visit to measure blood pressure, respond to a baseline survey, and receive remote patient monitoring devices and instructions to take home with them (home blood pressure monitor, wrist-worn sensor to track sleep activity, and associated apps)
* receive a random allocation to one of two groups: control condition (receive cash incentives at the end of the study for measuring blood pressure as instructed) or intervention condition (receive weekly cash incentives throughout the study for measuring blood pressure as instructed)
* use remote patient monitoring devices during a two month study period, receive weekly reports on adherence to blood pressure monitoring, and receive weekly financial incentives (intervention condition only)
* attend one follow-up visit at 2 months to measure their blood pressure, complete a follow-up survey, return the remote patient monitoring devices, and receive financial incentives for blood pressure monitoring (control condition only)
Researchers will compare the immediate and delayed incentive groups to see if there are differences in blood pressure monitoring adherence rates and blood pressure control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Age ≥40 years
- receive care at a participating FQHC
- taking blood pressure medication
- uncontrolled blood pressure at most recent clinic visit (systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥80 mm Hg)
- ability to understand and speak English
- able to access a smartphone
- currently participating in another clinical trial or research study on blood pressure, medication-taking, or sleep
- unable or unwilling to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Financial Incentives for BP monitoring Remote Patient Monitoring * instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * immediate financial incentives for home blood pressure monitoring distributed weekly Immediate Financial Incentives for BP monitoring Immediate financial incentives * instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * immediate financial incentives for home blood pressure monitoring distributed weekly Delayed Financial Incentives for BP monitoring Remote Patient Monitoring * instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * delayed financial incentives for home blood pressure monitoring distributed at the end of the study Delayed Financial Incentives for BP monitoring Self-monitoring of hypertension-related factors * instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * delayed financial incentives for home blood pressure monitoring distributed at the end of the study Delayed Financial Incentives for BP monitoring Delayed financial incentives * instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * delayed financial incentives for home blood pressure monitoring distributed at the end of the study Immediate Financial Incentives for BP monitoring Self-monitoring of hypertension-related factors * instructions for participating in a 2-month remote patient monitoring program * home blood pressure monitor and associated smartphone app, which includes a module for logging medication-taking * wrist-worn sensor and associated smartphone app * weekly adherence feedback to home blood pressure monitoring * immediate financial incentives for home blood pressure monitoring distributed weekly
- Primary Outcome Measures
Name Time Method Between-group difference in weekly adherence to blood pressure monitoring 8 weeks Weekly adherence to blood pressure monitoring will be defined as the number of days that the participant used the home blood pressure monitor at least once, captured in the blood pressure monitoring app usage data.
- Secondary Outcome Measures
Name Time Method Between-group mean difference in change in systolic blood pressure 8 weeks Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines.
Between-group difference in the proportion with blood pressure control (<130/80 mm Hg) 8 weeks Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines. Blood pressure control will be defined as systolic \<130 mm Hg and diastolic \<80 mm Hg.
Between-group mean difference in change in diastolic blood pressure 8 weeks Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines.
Between-group difference in the proportion with systolic blood pressure control (<130 mm Hg) 8 weeks Blood pressure will be measured at baseline and 8-week follow-up by a certified Clinical Research Coordinator using the average of three seated blood pressure measurements and in accordance with American Heart Association (AHA) guidelines. Systolic blood pressure control will be defined as systolic \<130 mm Hg.
Trial Locations
- Locations (2)
CommuniHealth Services
🇺🇸Bastrop, Louisiana, United States
David Raines Community Health Center
🇺🇸Shreveport, Louisiana, United States