Trial Outcomes & Findings for Connected Health Blood Pressure Monitoring In Stroke and TIA Patients (NCT NCT02450760)
NCT ID: NCT02450760
Last Updated: 2022-02-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
90 Days
Results posted on
2022-02-17
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Connected Health Blood Pressure Monitoring In Stroke and TIA Patients
Baseline characteristics by cohort
| Measure |
Control
n=15 Participants
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
|
Social Incentive
n=18 Participants
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
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 9.3 • n=39 Participants
|
59.4 years
STANDARD_DEVIATION 8.6 • n=41 Participants
|
58.9 years
STANDARD_DEVIATION 8.8 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=39 Participants
|
18 participants
n=41 Participants
|
33 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: All enrolled subjects
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.
Outcome measures
| Measure |
Control
n=15 Participants
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
|
Social Incentive
n=18 Participants
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
|
|---|---|---|
|
Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed
|
40 percentage of requested BP measurements
Interval 16.0 to 73.0
|
60 percentage of requested BP measurements
Interval 31.0 to 91.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Enrolled subjects
Difference in systolic blood pressure from the first 7 days of measurement to the last 7 days of measurement for each subject
Outcome measures
| Measure |
Control
n=15 Participants
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
|
Social Incentive
n=18 Participants
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
|
|---|---|---|
|
Change in Systolic Blood Pressure Over Study Period
|
3.1 mm Hg
Standard Deviation 14.0
|
2.7 mm Hg
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Subjects who completed day 90 interview
Outcome measures
| Measure |
Control
n=8 Participants
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
|
Social Incentive
n=13 Participants
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
|
|---|---|---|
|
Number of Physician Visits
|
2 physician visits
Interval 2.0 to 3.5
|
3 physician visits
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Subjects who completed day 90 interview
Outcome measures
| Measure |
Control
n=8 Participants
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
|
Social Incentive
n=13 Participants
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
|
|---|---|---|
|
Number of Emergency Department Visits
|
0 Number of ED visits
Interval 0.0 to 0.0
|
1 Number of ED visits
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: subjects completing day 90 interview
Outcome measures
| Measure |
Control
n=8 Participants
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
|
Social Incentive
n=13 Participants
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
|
|---|---|---|
|
Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)
|
0 Number of changes to BP medications
Interval 0.0 to 1.0
|
0 Number of changes to BP medications
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 24 subjects completed 90 day survey
Number of patients who felt that device was easy or very easy to use
Outcome measures
| Measure |
Control
n=14 Participants
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
|
Social Incentive
n=10 Participants
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
|
|---|---|---|
|
Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of participants who felt that BP monitoring was useful or very useful
Outcome measures
| Measure |
Control
n=14 Participants
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
|
Social Incentive
n=10 Participants
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
|
|---|---|---|
|
Number of Patients That Perceived Blood Pressure Monitoring to be Useful
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 90 daysPatients perception of whether or not BP was well controlled
Outcome measures
| Measure |
Control
n=14 Participants
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
|
Social Incentive
n=10 Participants
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
|
|---|---|---|
|
Number of Patients Who Felt They Had Well-controlled Blood Pressure
|
10 Participants
|
9 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Social Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place