Ischemic Attack, Transient, Stroke
Conditions
Brief summary
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.
Interventions
OTHERSocial incentive
Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult, age ≥ 18 years * History of ischemic stroke or high risk TIA (defined by ABCD2 ≥ 4)between 2 weeks and 12 months prior to enrollment * Hypertensive at time of enrollment, defined by SBP\>140 mm Hg or DBP \>90 mm Hg at the time of study screening * Must own a smart phone capable of interacting with the connected blood pressure cuff (Apple iPhone 3GS or higher; Android 4.0 or higher with Bluetooth connectivity) * Willingness and ability to sign informed consent by patient
Exclusion criteria
* Moderate or severe disability, defined by modified Rankin Scale ≥ 3. * Expected residence in a rehabilitation hospital, nursing facility or assisted living community during the study period. * Upper arm circumference \<9 inches or \>17 inches * Inability to monitor BP in both of the upper arms (i.e. history of bilateral radical mastectomy, bilateral severe subclavian stenosis, or bilateral arterial venous fistulas for dialysis). * Blood pressure discrepancy between arms of \>10 mm Hg. * Inability to follow-up at 90 days and return BP monitor * Active participation in another clinical trial * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed | 90 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Physician Visits | 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 | — |
| Change in Systolic Blood Pressure Over Study Period | 90 days | Difference in systolic blood pressure from the first 7 days of measurement to the last 7 days of measurement for each subject |
| Number of Patients That Perceived Blood Pressure Monitoring to be Useful | 90 days | Number of participants who felt that BP monitoring was useful or very useful |
| Number of Patients Who Felt They Had Well-controlled Blood Pressure | 90 days | Patients perception of whether or not BP was well controlled |
| Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use | 90 days | Number of patients who felt that device was easy or very easy to use |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 18 |
| Total | 33 |
Baseline characteristics
| Characteristic | Control | Total | Social Incentive |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 9.3 | 58.9 years STANDARD_DEVIATION 8.8 | 59.4 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 16 Participants | 10 Participants |
| Region of Enrollment United States | 15 participants | 33 participants | 18 participants |
| Sex: Female, Male Female | 8 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 18 |
| other Total, other adverse events | 0 / 15 | 0 / 18 |
| serious Total, serious adverse events | 0 / 15 | 0 / 18 |
Outcome results
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.
Time frame: 90 Days
Population: All enrolled subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed | 40 percentage of requested BP measurements |
| Social Incentive | Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed | 60 percentage of requested BP measurements |
p-value: 0.29Wilcoxon (Mann-Whitney)
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
Time frame: 90 days
Population: Enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Systolic Blood Pressure Over Study Period | 3.1 mm Hg | Standard Deviation 14 |
| Social Incentive | Change in Systolic Blood Pressure Over Study Period | 2.7 mm Hg | Standard Deviation 14.6 |
p-value: 0.95t-test, 2 sided
Secondary
Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)
Time frame: 90 days
Population: subjects completing day 90 interview
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent) | 0 Number of changes to BP medications |
| Social Incentive | Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent) | 0 Number of changes to BP medications |
Secondary
Number of Emergency Department Visits
Time frame: 90 days
Population: Subjects who completed day 90 interview
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Number of Emergency Department Visits | 0 Number of ED visits |
| Social Incentive | Number of Emergency Department Visits | 1 Number of ED visits |
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
Time frame: 90 days
Population: 24 subjects completed 90 day survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use | 9 Participants |
| Social Incentive | Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use | 9 Participants |
p-value: 0.15Chi-squared
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
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients That Perceived Blood Pressure Monitoring to be Useful | 4 Participants |
| Social Incentive | Number of Patients That Perceived Blood Pressure Monitoring to be Useful | 3 Participants |
p-value: 0.83Chi-squared
Secondary
Number of Patients Who Felt They Had Well-controlled Blood Pressure
Patients perception of whether or not BP was well controlled
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients Who Felt They Had Well-controlled Blood Pressure | 10 Participants |
| Social Incentive | Number of Patients Who Felt They Had Well-controlled Blood Pressure | 9 Participants |
p-value: 0.26Chi-squared
Secondary
Number of Physician Visits
Time frame: 90 days
Population: Subjects who completed day 90 interview
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Number of Physician Visits | 2 physician visits |
| Social Incentive | Number of Physician Visits | 3 physician visits |