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

May 20, 2020 updated by: Karina Villaluna Murray, Vancouver Coastal Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Stroke Program - Stroke Prevention Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants will be selected from the Vancouver General Hospital's stroke prevention clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants or caregivers using the home telemonitoring program
Time Frame: Assessed at 6 months
1. Proportion of participants or caregivers persisting with use of the home telemonitoring program within the six-month monitoring period.
Assessed at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion at 6 months
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
Assessed throughout six months program duration
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
At 1 month post enrollment
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
At 3 months post enrollment
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
At 6 months post enrollment
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
At 1 month post enrollment
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
At 3 months post enrollment
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
At 6 months post enrollment
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.
Assessed through study completion at 6 months
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
Assessed/compared at enrolment versus at three and six months.
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
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
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
From date of enrollment, assessed up to 6 month visit
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
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 stroke recurrence based on self-report
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 hospital administrative data
Six months (180 days) - from enrolment to study completion.
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.
Six months (180 days) - from enrolment to study completion.
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.
3 months (90 days) post study completion.
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.
Six months (180 days) - from enrolment to study completion.
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.
At the six-month (180 day) time point. We welcome feedback from the participant's GP during the 6 month study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vancouver Coastal Health Research Institute

Collaborators

Vancouver General Hospital
VGH and UBC Hospital Foundation

Investigators

  • Principal Investigator: Karina Villaluna, BSN, CNN(C), Vancouver Stroke Program (UBC) - Research Office

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

November 10, 2019

Study Completion (Actual)

November 10, 2019

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 20, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-02093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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