TEC4Home Stroke - Feasibility of Home Telemonitoring Technology in Managing Hypertension Among Stroke/TIA Patients

Sponsor

Vancouver Coastal Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03712033

Collaborator

VGH and UBC Hospital Foundation (Other), Vancouver General Hospital (Other)

Enrollment

Location

20.3

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will test the feasibility of a home blood pressure telemonitoring (HBPTM) system in patients with minor stroke or TIA in the past year. The telemonitoring system will consist of a blood pressure machine and an online survey to submit blood pressure measurements. The investigators want to test whether patients can persistently use the telemonitoring system with ease and whether telephone instructions for blood pressure medications from the research nurse can be correctly understood. A secondary purpose of this study is to look at the effects of telemonitoring in blood pressure and stroke recurrence.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Stroke Blood Pressure, High Systolic Hypertension Transient Ischemic Attack Cerebrovascular Accident

Detailed Description

The investigators propose a two-year pilot study (TEC4Home Stroke) to assess the feasibility of using home telemonitoring technology in managing hypertension among patients with minor stroke/TIA (NIH Stroke Scale Score <5) at the VGH Stroke Prevention Clinic (SPC). The Vancouver Stroke Program SPC receives 1200 referrals per year for assessment of patients with strokes or TIAs. Of the total number of patients referred to the SPC, 45% were deemed as hypertensive patients through any one of: (1) medical history of hypertension, (2) on antihypertensive medications or (3) having blood pressure measurements above 140/90 mm Hg during their assessment at the clinic.

This project, which includes baseline assessments of home supports and cognition, will assess the specific needs of the post-stroke population in determining feasibility of HBPTM and nurse-led hypertension treatment. Previous studies of aggressive hypertensive control regimens have shown that it takes approximately six months to consistently achieve target pressures (SPRINT, SPS3). Thus in this feasibility study, participants will be monitored for 6 months using home telemonitoring technology.

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

TEC4Home Stroke - Assessing the Feasibility of Home Telemonitoring Technology in Managing Hypertension Among Stroke/TIA Patients. Pilot Study at Vancouver Stroke Program in Collaboration With TEC4Home Heart Failure Team

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Nov 10, 2019

Actual Study Completion Date :

Nov 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
TEC4Home Stroke Cohort All participants or caregiver involved will be instructed to measure BP per the TEC4Home BP Telemonitoring Protocol. Participants will measure their BP daily, 4x/day, for the first week. After the first week, all weekly BP measurements will be done 3 days/week with 4 measurements a day. All readings must be taken before administration of antihypertensive medications, twice in the morning, 5 minutes apart and twice in the evening, 5 minutes apart. The TEC4Home telemonitoring nurse will review the BP measurements and contact the participant on a weekly basis until the end of the 6-month monitoring period. The telemonitoring nurse will adjust the antihypertensive medication doses as per the TEC4Home Stroke - Hypertension Management Algorithm.

Arm

Intervention/Treatment

TEC4Home Stroke Cohort

All participants or caregiver involved will be instructed to measure BP per the TEC4Home BP Telemonitoring Protocol. Participants will measure their BP daily, 4x/day, for the first week. After the first week, all weekly BP measurements will be done 3 days/week with 4 measurements a day. All readings must be taken before administration of antihypertensive medications, twice in the morning, 5 minutes apart and twice in the evening, 5 minutes apart. The TEC4Home telemonitoring nurse will review the BP measurements and contact the participant on a weekly basis until the end of the 6-month monitoring period. The telemonitoring nurse will adjust the antihypertensive medication doses as per the TEC4Home Stroke - Hypertension Management Algorithm.

Outcome Measures

Primary Outcome Measures

Proportion of participants or caregivers using the home telemonitoring program [Assessed at 6 months]
1. Proportion of participants or caregivers persisting with use of the home telemonitoring program within the six-month monitoring period.

Secondary Outcome Measures

Compliance to antihypertensive regimen [Through study completion at 6 months]
Number of participants or caregivers demonstrating correct understanding of and adherence to antihypertensive regimen after phone medication titration by telemonitoring nurse
Technological support requirement by participant or caregiver [Assessed throughout six months program duration]
Number of technological support calls to telemonitoring clinician by participant or caregiver
Comfort and Confidence with Home Health Monitoring Questionnaire [At 1 month post enrollment]
Participant or caregiver's perception of confidence with remote hypertension management program at 1 month
Comfort and Confidence with Home Health Monitoring Questionnaire [At 3 months post enrollment]
Participant or caregiver's perception of confidence with remote hypertension management program at 3 months
Comfort and Confidence with Home Health Monitoring Questionnaire [At 6 months post enrollment]
Participant or caregiver's perception of confidence with remote hypertension management program at 6 months
Comfort and Confidence with Home Health Monitoring Questionnaire [At 1 month post enrollment]
Participant or caregiver's perception of convenience of remote hypertension management program at 1 month
Comfort and Confidence with Home Health Monitoring Questionnaire [At 3 months post enrollment]
Participant or caregiver's perception of convenience of remote hypertension management program at 3 months
Comfort and Confidence with Home Health Monitoring Questionnaire [At 6 months post enrollment]
Participant or caregiver's perception of convenience of remote hypertension management program at 6 months
Home Health Monitoring Follow-up Questionnaire [Assessed through study completion at 6 months]
Description of Reasons for Discontinuation of telemonitoring. Only applicable if participant discontinues the telemonitoring program for any reason.
Difference in mean systolic blood pressure (SBP) [Assessed/compared at enrolment versus at three and six months.]
Comparison of mean SBP at enrollment versus three and six months
Difference in mean diastolic blood pressure (DBP) [Assessed/compared at enrolment versus three and six months.]
Comparison of mean DBP at enrollment versus at three and six months
Time to achieve a reduction in SBP of 5 mm Hg and 10 mm Hg from mean enrolment SBP [From date of enrollment, assessed up to 6 month visit]
Number of days to achieve a reduction in SBP of 5 mm Hg and 10 mm Hg from mean enrolment SBP
Rate of stroke recurrence based on hospital administrative data [Six months (180 days) - from enrolment to study completion.]
Rate of stroke recurrence based on hospital administrative data
Rate of stroke recurrence based on self-report [Six months (180 days) - from enrolment to study completion.]
Rate of stroke recurrence based on self-report
Rate of hospital re-admission based on hospital administrative data [Six months (180 days) - from enrolment to study completion.]
Rate of hospital re-admission based on hospital administrative data
Rate of hospital re-admission based on self-report [Six months (180 days) - from enrolment to study completion.]
Rate of hospital re-admission based on self-report.
BP at 90-day post-study follow-up [3 months (90 days) post study completion.]
BP as measured at follow-up visit at the Stroke Program Research Office by the study nurse.
Mean length of time per Telehealth nurse phone call and mean post-call documentation time [Six months (180 days) - from enrolment to study completion.]
Recorded to determine the time burden per study participant placed on the Telehealth nurse.
GP feedback on the Telehealth program [At the six-month (180 day) time point. We welcome feedback from the participant's GP during the 6 month study period.]
The participant's GP, if they have one, will be contacted with information regarding their patients' participation and the CHEP-guided management algorithm. The GP will receive a summary of the follow-up phone calls by the Telehealth nurse and notes from in-person follow-up study visits. We will ask GPs to inform us via fax or email after any patient follow-up visit and to additionally touch base if there are concerns about the current medication regimen or if changes are made. At the end of the study, GPs will receive an exit questionnaire regarding their experience in managing their patients during the telehealth program and inviting suggestions for future GP/community health engagement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who had a minor stroke or TIA in the past year and seen at SPC.
Systolic hypertension at least 10 mm Hg above target, defined as any of:

A definite history of systolic hypertension before stroke as per CHEP (Canadian Hypertension Education Program) guidelines, or
Currently receiving antihypertensive medications, or
Any two documented SBP above 150 mm Hg (or above 140 mm Hg if diabetic) - either by history, on referral forms, or on an average of blood pressure measurements done during the patient's appointment at SPC

18 years or older
Informed consent from patient or substitute decision-maker
Able to comprehend medication instructions over the phone in English, or has a caregiver able to do so.
If patient is unable to directly participate in the Telehealth intervention (e.g. severe aphasia, has English as a second language, modified Rankin Scale score (mRS)

4, a caregiver or family must be available to participate with the BP monitoring procedures and medication titration).

Exclusion Criteria:

Patients admitted at long term care facilities or rehabilitation facilities (If admitted at rehabilitation facility, patient must be discharged prior to enrollment in the study)
Unable to comply with home blood pressure monitoring procedures for any other reason
Participation in other interventional (i.e., drug or device) clinical trials
Severe illness or another major illness that would affect ability to attend the study visits
Dialysis or diagnosis of end stage renal disease
Secondary hypertension (e.g. hypertension secondary to a known medical condition such as renal artery stenosis, pheochromocytoma, etc.)
Life expectancy < 12 months