Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Financial Incentives for BP monitoring | Experimental |
|
|
| Delayed Financial Incentives for BP monitoring | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Patient Monitoring | Behavioral | Participants will be given a home blood pressure machine and instructed to take their blood pressure twice/day (once in the morning and once at night) for the duration of the 2-month study. Blood pressure values will be immediately available in their patient-facing portal accessible via smartphone app, and patients will receive weekly feedback reports on their adherence to the home blood pressure monitoring protocol. Patients' blood pressure values will also be accessible to their clinical care team via an administrator portal, which will alert clinicians of any values above or below pre-specified clinical thresholds. |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in weekly adherence to blood pressure monitoring | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group mean difference in change in systolic blood pressure | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient approached for recruitment | Number of patients with reachable phone numbers or approached in clinic | 3 months |
| Number of patients assessed for eligibility | Number of patients who begin eligibility screener |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie Krousel-Wood, MD, MSPH | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CommuniHealth Services | Bastrop | Louisiana | 71220 | United States | ||
| David Raines Community Health Center |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Self-monitoring of hypertension-related factors | Behavioral | As part of self-monitoring of hypertension-related factors, the blood pressure monitoring patient-facing app will also prompt patients daily to report whether or not they took their blood pressure medication. in addition, participants will be provided with a wrist-worn sensor and instructed to wear it at night to track their sleep activity. Data on sleep activity will be available to patients through a separate patient-facing app accessible on their smartphone. |
|
| Immediate financial incentives | Behavioral | Weekly financial incentives for measuring their blood pressure as instructed (up to $25/week: $5/day for up to 5 days/week) |
|
| Delayed financial incentives | Behavioral | Financial incentives for measuring their blood pressure as instructed in one payment at the end of the study (up to $25/week: $5/day for up to 5 days/week) |
|
| Between-group mean difference in change in diastolic blood pressure |
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. |
| 8 weeks |
| Between-group difference in the proportion with blood pressure control (<130/80 mm Hg) | 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. | 8 weeks |
| Between-group difference in the proportion with systolic blood pressure control (<130 mm Hg) | 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. | 8 weeks |
| 3 months |
| Number of patients enrolled | Number of patients who consent and are randomized | 3 months |
| Number of patients who receive intended treatment | Proportion of total possible financial incentive received | 2 months |
| Shreveport |
| Louisiana |
| 71107 |
| United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D015438 | Health Behavior |
| D010342 | Patient Acceptance of Health Care |
| D010358 | Patient Participation |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided