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The goal of this pilot project is to assess adherence with home blood pressure monitoring in hypertensive patients with a history of cerebral infarction and to determine if a social incentive improves adherence with monitoring. Enrolled subjects will all have a history of cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at the time of enrollment. To be eligible subjects will also be required to own a smart phone (iOS or Android operating system). After enrollment, patients will be given a home blood pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be randomly assigned to a social incentive program, in which a social supporter receives updates via email and/or text message on the subject's adherence with BP monitoring and their average blood pressure. This study will provide important pilot data which will inform the design of future studies utilizing connected health and automated systems to improve home blood pressure monitoring and blood pressure control in patients with a history of stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week. |
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| Social Incentive | Other | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social incentive | Other | Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed | Percentage of requested blood pressure measurements completed. Note that subjects were enrolled for 90 +/- 7 days, and so this calculation was completed at day 83, rather than day 90. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure Over Study Period | Difference in systolic blood pressure from the first 7 days of measurement to the last 7 days of measurement for each subject | 90 days |
| Number of Physician Visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Mullen, M.D | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence |
| FG001 | Social Incentive | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed | Percentage of requested blood pressure measurements completed. Note that subjects were enrolled for 90 +/- 7 days, and so this calculation was completed at day 83, rather than day 90. | All enrolled subjects | Posted | Median | Inter-Quartile Range | percentage of requested BP measurements | 90 Days |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Mullen | University of Pennsylvania | 215-662-3339 | Michael.Mullen@Pennmedicine.Upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2016 | Jul 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 90 days |
| Number of Emergency Department Visits | 90 days |
| Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent) | 90 days |
| Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use | Number of patients who felt that device was easy or very easy to use | 90 days |
| Number of Patients That Perceived Blood Pressure Monitoring to be Useful | Number of participants who felt that BP monitoring was useful or very useful | 90 days |
| Number of Patients Who Felt They Had Well-controlled Blood Pressure | Patients perception of whether or not BP was well controlled | 90 days |
| BG001 | Social Incentive | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Social Incentive | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence |
|
|
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| Secondary | Change in Systolic Blood Pressure Over Study Period | Difference in systolic blood pressure from the first 7 days of measurement to the last 7 days of measurement for each subject | Enrolled subjects | Posted | Mean | Standard Deviation | mm Hg | 90 days |
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| Secondary | Number of Physician Visits | Subjects who completed day 90 interview | Posted | Median | Inter-Quartile Range | physician visits | 90 days |
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| Secondary | Number of Emergency Department Visits | Subjects who completed day 90 interview | Posted | Median | Inter-Quartile Range | Number of ED visits | 90 days |
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| Secondary | Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent) | subjects completing day 90 interview | Posted | Median | Inter-Quartile Range | Number of changes to BP medications | 90 days |
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| Secondary | Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use | Number of patients who felt that device was easy or very easy to use | 24 subjects completed 90 day survey | Posted | Count of Participants | Participants | 90 days |
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| Secondary | Number of Patients That Perceived Blood Pressure Monitoring to be Useful | Number of participants who felt that BP monitoring was useful or very useful | Posted | Count of Participants | Participants | 90 days |
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| Secondary | Number of Patients Who Felt They Had Well-controlled Blood Pressure | Patients perception of whether or not BP was well controlled | Posted | Count of Participants | Participants | 90 days |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Social Incentive | Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence | 0 | 18 | 0 | 18 | 0 | 18 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |