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

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ClinicalTrials.gov Identifier: NCT03712033
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
VGH and UBC Hospital Foundation
Vancouver General Hospital
Information provided by (Responsible Party):
Karina Villaluna Murray, Vancouver Coastal Health Research Institute

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.

Condition or disease
Hypertension Stroke Blood Pressure, High Systolic Hypertension Transient Ischemic Attack Cerebrovascular Accident

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : November 10, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be selected from the Vancouver General Hospital's stroke prevention clinic.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712033


Contacts
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Contact: Princess King-Azote, BSMT, MD (604)-875-5818 princess.king-azote@ubc.ca

Locations
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Canada, British Columbia
Vancouver Stroke Program - Stroke Prevention Clinic Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Princess King-Azote, BSMT, MD    604-875-5818    princess.king-azote@ubc.ca   
Sub-Investigator: Oscar Benavente, MD         
Sub-Investigator: Thalia S Field, MD         
Sub-Investigator: Laura Wilson, MD         
Sub-Investigator: Colleen Murphy, MD         
Sub-Investigator: Katelyn Halpape         
Sub-Investigator: Samuel Yip, MD         
Sub-Investigator: Kendall Ho, MD         
Sub-Investigator: Jennifer Cordeiro, BAA         
Sub-Investigator: Sharanpal Mann, MD         
Sponsors and Collaborators
Vancouver Coastal Health Research Institute
VGH and UBC Hospital Foundation
Vancouver General Hospital
Investigators
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Principal Investigator: Karina Villaluna, BSN, CNN(C) Vancouver Stroke Program (UBC) - Research Office

Additional Information:
Publications:
Crabtree, MM, Stuart-Shor, E. Implementing Home Blood Pressure Monitoring into Usual Care. The Journal of Nurse Practitioners (2014) 10(8): 607-610.

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Responsible Party: Karina Villaluna Murray, Clinical Research Coordinator and Manager, Vancouver Coastal Health Research Institute
ClinicalTrials.gov Identifier: NCT03712033     History of Changes
Other Study ID Numbers: H17-02093
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karina Villaluna Murray, Vancouver Coastal Health Research Institute:
Hypertension management
Stroke
Secondary Prevention
Modifiable stroke risk factor
Home blood pressure monitoring system
Telehealth
Telus Health
Telemonitoring
Systolic hypertension
Cerebrovascular Accident
TIA

Additional relevant MeSH terms:
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Hypertension
Stroke
Ischemic Attack, Transient
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Ischemia