Clinical trial NCT03712033: TEC4Home Stroke - Feasibility of Home Telemonitoring Technology in Managing Hypertension Among Stroke/TIA Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Stroke
Blood Pressure, High
Systolic Hypertension
Transient Ischemic Attack
Cerebrovascular Accident
Keywords: Hypertension management
Stroke
Secondary Prevention
Modifiable stroke risk factor
Home blood pressure monitoring system
Telehealth
Telus Health
Telemonitoring
Systolic hypertension
Cerebrovascular Accident
TIA
Lead sponsor: Vancouver Coastal Health Research Institute
Sponsor class: OTHER
Collaborators: name: VGH and UBC Hospital Foundation
name: Vancouver General Hospital
First posted: 2018-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be selected from the Vancouver General Hospital's stroke prevention clinic.

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.

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.

Eligibility criteria: 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:

  1. A definite history of systolic hypertension before stroke as per CHEP (Canadian Hypertension Education Program) guidelines, or
  2. Currently receiving antihypertensive medications, or
  3. 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

Primary outcomes:
measure: Proportion of participants or caregivers using the home telemonitoring program
timeFrame: Assessed at 6 months
Secondary outcomes:
measure: Compliance to antihypertensive regimen
timeFrame: Through study completion at 6 months
measure: Technological support requirement by participant or caregiver
timeFrame: Assessed throughout six months program duration
measure: Comfort and Confidence with Home Health Monitoring Questionnaire
timeFrame: At 1 month post enrollment
measure: Comfort and Confidence with Home Health Monitoring Questionnaire
timeFrame: At 3 months post enrollment
measure: Comfort and Confidence with Home Health Monitoring Questionnaire
timeFrame: At 6 months post enrollment
measure: Comfort and Confidence with Home Health Monitoring Questionnaire
timeFrame: At 1 month post enrollment
measure: Comfort and Confidence with Home Health Monitoring Questionnaire
timeFrame: At 3 months post enrollment
measure: Comfort and Confidence with Home Health Monitoring Questionnaire
timeFrame: At 6 months post enrollment
measure: Home Health Monitoring Follow-up Questionnaire
timeFrame: Assessed through study completion at 6 months
measure: Difference in mean systolic blood pressure (SBP)
timeFrame: Assessed/compared at enrolment versus at three and six months.
measure: Difference in mean diastolic blood pressure (DBP)
timeFrame: Assessed/compared at enrolment versus three and six months.
measure: Time to achieve a reduction in SBP of 5 mm Hg and 10 mm Hg from mean enrolment SBP
timeFrame: From date of enrollment, assessed up to 6 month visit
measure: Rate of stroke recurrence based on hospital administrative data
timeFrame: Six months (180 days) - from enrolment to study completion.
measure: Rate of stroke recurrence based on self-report
timeFrame: Six months (180 days) - from enrolment to study completion.
measure: Rate of hospital re-admission based on hospital administrative data
timeFrame: Six months (180 days) - from enrolment to study completion.
measure: Rate of hospital re-admission based on self-report
timeFrame: Six months (180 days) - from enrolment to study completion.
measure: BP at 90-day post-study follow-up
timeFrame: 3 months (90 days) post study completion.
measure: Mean length of time per Telehealth nurse phone call and mean post-call documentation time
timeFrame: Six months (180 days) - from enrolment to study completion.
measure: GP feedback on the Telehealth program
timeFrame: At the six-month (180 day) time point. We welcome feedback from the participant's GP during the 6 month study period.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Stroke Program - Stroke Prevention Clinic
state: British Columbia
Study officials:
affiliation: Vancouver Stroke Program (UBC) - Research Office
name: Karina Villaluna, BSN, CNN(C)
role: PRINCIPAL_INVESTIGATOR
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