CHAMPS: Connected Health Blood Pressure Monitoring In Stroke and TIA Patients

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02450760
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 68
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Ischemic Attack, Transient	Other: Social incentive	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Other: Social incentive; Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence
Other: 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.	Other: Social incentive; Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. Number of Physician Visits [90 days]

3. Number of Emergency Department Visits [90 days]

4. Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent) [90 days]

5. 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

6. 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

7. Number of Patients Who Felt They Had Well-controlled Blood Pressure [90 days]

   Patients perception of whether or not BP was well controlled

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Michael Mullen, M.D, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 26, 2016

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02450760
• Other Study ID Numbers: 821743
• First Posted: May 21, 2015
• Last Update Posted: Feb 17, 2022
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Stroke; Ischemic Attack, Transient

Study Results

Participant Flow

Arm/Group Title	Control	Social Incentive
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	15	18
COMPLETED	15	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	Social Incentive	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	15	18	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.4 (9.3)	59.4 (8.6)	58.9 (8.8)
Sex: Female, Male (Count of Participants)
Female	8 53.3%	11 61.1%	19 57.6%
Male	7 46.7%	7 38.9%	14 42.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 5.6%	1 3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 60%	7 38.9%	16 48.5%
White	6 40%	10 55.6%	16 48.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	18 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed
Description	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

Outcome Measure Data

Analysis Population Description

All enrolled subjects

Arm/Group Title	Control	Social Incentive
Arm/Group Description	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	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
Measure Participants	15	18
Median (Inter-Quartile Range) [percentage of requested BP measurements]	40	60

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Social Incentive
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Change in Systolic Blood Pressure Over Study Period
Description	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

Outcome Measure Data

Analysis Population Description

Enrolled subjects

Arm/Group Title	Control	Social Incentive
Arm/Group Description	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	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
Measure Participants	15	18
Mean (Standard Deviation) [mm Hg]	3.1 (14.0)	2.7 (14.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Social Incentive
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Number of Physician Visits
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Subjects who completed day 90 interview

Arm/Group Title	Control	Social Incentive
Arm/Group Description	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	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
Measure Participants	8	13
Median (Inter-Quartile Range) [physician visits]	2	3

4. Secondary Outcome

Title	Number of Emergency Department Visits
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Subjects who completed day 90 interview

Arm/Group Title	Control	Social Incentive
Arm/Group Description	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	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
Measure Participants	8	13
Median (Inter-Quartile Range) [Number of ED visits]	0	1

5. Secondary Outcome

Title	Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

subjects completing day 90 interview

Arm/Group Title	Control	Social Incentive
Arm/Group Description	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	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
Measure Participants	8	13
Median (Inter-Quartile Range) [Number of changes to BP medications]	0	0

6. Secondary Outcome

Title	Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use
Description	Number of patients who felt that device was easy or very easy to use
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

24 subjects completed 90 day survey

Arm/Group Title	Social Support	Control
Arm/Group Description	Social support intervention group	Control group
Measure Participants	14	10
Count of Participants [Participants]	9 60%	9 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Social Incentive
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Number of Patients That Perceived Blood Pressure Monitoring to be Useful
Description	Number of participants who felt that BP monitoring was useful or very useful
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Support	Control
Arm/Group Description	Social support intervention arm	Control Arm
Measure Participants	14	10
Count of Participants [Participants]	4 26.7%	3 16.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Social Incentive
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	Number of Patients Who Felt They Had Well-controlled Blood Pressure
Description	Patients perception of whether or not BP was well controlled
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Social Support	Control
Arm/Group Description	Social Support Arm	Control Arm
Measure Participants	14	10
Count of Participants [Participants]	10 66.7%	9 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Social Incentive
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	90 days
Adverse Event Reporting Description	Does not differ
Arm/Group Title	Control		Social Incentive
Arm/Group Description	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		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
All Cause Mortality
	Control		Social Incentive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/18 (0%)
Serious Adverse Events
	Control		Social Incentive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Control		Social Incentive
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.