Hypertension Clinical Trial
— BENEFIT-HOfficial title:
Building Engagement Using Financial Incentives Trial - Hypertension
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Tulane University | National Heart, Lung, and Blood Institute (NHLBI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patient approached for recruitment | Number of patients with reachable phone numbers or approached in clinic | 3 months | |
Other | Number of patients assessed for eligibility | Number of patients who begin eligibility screener | 3 months | |
Other | Number of patients enrolled | Number of patients who consent and are randomized | 3 months | |
Other | Number of patients who receive intended treatment | Proportion of total possible financial incentive received | 2 months | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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