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Completed

NCT Number: NCT03712033

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of participants or caregivers using the home telemonitoring program

    Time frame: Assessed at 6 months

    • Proportion of participants or caregivers persisting with use of the home telemonitoring program within the six-month monitoring period.

Secondary outcomes

  1. Compliance to antihypertensive regimen

    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

  2. Technological support requirement by participant or caregiver

    Time frame: Assessed throughout six months program duration

    Number of technological support calls to telemonitoring clinician by participant or caregiver

  3. Comfort and Confidence with Home Health Monitoring Questionnaire

    Time frame: At 1 month post enrollment

    Participant or caregiver's perception of confidence with remote hypertension management program at 1 month

  4. Comfort and Confidence with Home Health Monitoring Questionnaire

    Time frame: At 3 months post enrollment

    Participant or caregiver's perception of confidence with remote hypertension management program at 3 months

  5. Comfort and Confidence with Home Health Monitoring Questionnaire

    Time frame: At 6 months post enrollment

    Participant or caregiver's perception of confidence with remote hypertension management program at 6 months

  6. Comfort and Confidence with Home Health Monitoring Questionnaire

    Time frame: At 1 month post enrollment

    Participant or caregiver's perception of convenience of remote hypertension management program at 1 month

  7. Comfort and Confidence with Home Health Monitoring Questionnaire

    Time frame: At 3 months post enrollment

    Participant or caregiver's perception of convenience of remote hypertension management program at 3 months

  8. Comfort and Confidence with Home Health Monitoring Questionnaire

    Time frame: At 6 months post enrollment

    Participant or caregiver's perception of convenience of remote hypertension management program at 6 months

  9. Home Health Monitoring Follow-up Questionnaire

    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.

  10. Difference in mean systolic blood pressure (SBP)

    Time frame: Assessed/compared at enrolment versus at three and six months.

    Comparison of mean SBP at enrollment versus three and six months

  11. Difference in mean diastolic blood pressure (DBP)

    Time frame: Assessed/compared at enrolment versus three and six months.

    Comparison of mean DBP at enrollment versus at three and six months

  12. Time to achieve a reduction in SBP of 5 mm Hg and 10 mm Hg from mean enrolment SBP

    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

  13. 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 hospital administrative data

  14. Rate of stroke recurrence based on self-report

    Time frame: Six months (180 days) - from enrolment to study completion.

    Rate of stroke recurrence based on self-report

  15. 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 hospital administrative data

  16. Rate of hospital re-admission based on self-report

    Time frame: Six months (180 days) - from enrolment to study completion.

    Rate of hospital re-admission based on self-report.

  17. BP at 90-day post-study follow-up

    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.

  18. Mean length of time per Telehealth nurse phone call and mean post-call documentation time

    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.

  19. GP feedback on the Telehealth program

    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.

Sponsors and collaborators

Lead sponsor

Vancouver Coastal Health Research Institute

Other

Collaborators

  • VGH and UBC Hospital Foundation
  • Vancouver General Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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