Clinical trial NCT06195839: Building Engagement Using Financial Incentives Trial - Hypertension
Official title: Building Engagement Using Financial Incentives Trial - Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Health Behavior
Healthcare Patient Acceptance
Patient Engagement
Adherence, Patient
Keywords: preventive healthcare
patient financial incentives
federally qualified health center (FQHC)
remote patient monitoring (RPM)
health services
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* currently participating in another clinical trial or research study on blood pressure, medication-taking, or sleep
* unable or unwilling to give informed consent

Primary outcomes:
measure: Between-group difference in weekly adherence to blood pressure monitoring
timeFrame: 8 weeks
Secondary outcomes:
measure: Between-group mean difference in change in systolic blood pressure
timeFrame: 8 weeks
measure: Between-group mean difference in change in diastolic blood pressure
timeFrame: 8 weeks
measure: Between-group difference in the proportion with blood pressure control (<130/80 mm Hg)
timeFrame: 8 weeks
measure: Between-group difference in the proportion with systolic blood pressure control (<130 mm Hg)
timeFrame: 8 weeks
Other outcomes:
measure: Number of patient approached for recruitment
timeFrame: 3 months
measure: Number of patients assessed for eligibility
timeFrame: 3 months
measure: Number of patients enrolled
timeFrame: 3 months
measure: Number of patients who receive intended treatment
timeFrame: 2 months
Locations:
city: Bastrop
country: United States
facility: CommuniHealth Services
state: Louisiana
city: Shreveport
country: United States
facility: David Raines Community Health Center
state: Louisiana
Study officials:
affiliation: Tulane University
name: Marie Krousel-Wood, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: