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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of participants or caregivers using the home telemonitoring program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Proportion of participants or caregivers using the home telemonitoring program
时间窗: Assessed at 6 months
1. Proportion of participants or caregivers persisting with use of the home telemonitoring program within the six-month monitoring period.
次要结局
- Rate of hospital re-admission based on hospital administrative data(Six months (180 days) - from enrolment to study completion.)
- BP at 90-day post-study follow-up(3 months (90 days) post study completion.)
- Compliance to antihypertensive regimen(Through study completion at 6 months)
- Comfort and Confidence with Home Health Monitoring Questionnaire(At 6 months post enrollment)
- Home Health Monitoring Follow-up Questionnaire(Assessed through study completion at 6 months)
- Rate of hospital re-admission based on self-report(Six months (180 days) - from enrolment to study completion.)
- Difference in mean diastolic blood pressure (DBP)(Assessed/compared at enrolment versus 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)
- Rate of stroke recurrence based on hospital administrative data(Six months (180 days) - from enrolment to study completion.)
- Rate of stroke recurrence based on self-report(Six months (180 days) - from enrolment to study completion.)
- Technological support requirement by participant or caregiver(Assessed throughout six months program duration)
- Difference in mean systolic blood pressure (SBP)(Assessed/compared at enrolment versus at three and six months.)
- Mean length of time per Telehealth nurse phone call and mean post-call documentation time(Six months (180 days) - from enrolment to study completion.)
- 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.)
研究者
Karina Villaluna Murray
Clinical Research Coordinator and Manager
Vancouver Coastal Health Research Institute