Vancouver Stroke Program - Stroke Prevention Clinic
Vancouver, British Columbia, V5Z 1M9, Canada
NCT Number: NCT03712033
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.
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Notify Me18 year and older
All sexes
Observational
Vancouver, British Columbia, V5Z 1M9, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Assessed at 6 months
Time frame: 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
Time frame: Assessed throughout six months program duration
Number of technological support calls to telemonitoring clinician by participant or caregiver
Time frame: At 1 month post enrollment
Participant or caregiver's perception of confidence with remote hypertension management program at 1 month
Time frame: At 3 months post enrollment
Participant or caregiver's perception of confidence with remote hypertension management program at 3 months
Time frame: At 6 months post enrollment
Participant or caregiver's perception of confidence with remote hypertension management program at 6 months
Time frame: At 1 month post enrollment
Participant or caregiver's perception of convenience of remote hypertension management program at 1 month
Time frame: At 3 months post enrollment
Participant or caregiver's perception of convenience of remote hypertension management program at 3 months
Time frame: At 6 months post enrollment
Participant or caregiver's perception of convenience of remote hypertension management program at 6 months
Time frame: 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.
Time frame: Assessed/compared at enrolment versus at three and six months.
Comparison of mean SBP at enrollment versus three and six months
Time frame: Assessed/compared at enrolment versus three and six months.
Comparison of mean DBP at enrollment versus at three and six months
Time frame: 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
Time frame: Six months (180 days) - from enrolment to study completion.
Rate of stroke recurrence based on hospital administrative data
Time frame: Six months (180 days) - from enrolment to study completion.
Rate of stroke recurrence based on self-report
Time frame: Six months (180 days) - from enrolment to study completion.
Rate of hospital re-admission based on hospital administrative data
Time frame: Six months (180 days) - from enrolment to study completion.
Rate of hospital re-admission based on self-report.
Time frame: 3 months (90 days) post study completion.
BP as measured at follow-up visit at the Stroke Program Research Office by the study nurse.
Time frame: Six months (180 days) - from enrolment to study completion.
Recorded to determine the time burden per study participant placed on the Telehealth nurse.
Time frame: 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.
Vancouver Coastal Health Research Institute
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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