HypertensionNCT03712033

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

An observational study of Hypertension and Stroke, run by Vancouver Coastal Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Stroke, Blood Pressure, High
How many people: 50 participants
Where: 1 siteCanada
Study dates: 1 Mar 2018to 10 Nov 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Show all 9Show fewer

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Hypertension, Stroke, Blood Pressure, High, Systolic Hypertension, Transient Ischemic Attack, Cerebrovascular Accident
Keywords: Hypertension management, Stroke, Secondary Prevention, Modifiable stroke risk factor, Home blood pressure monitoring system, Telehealth, Telus Health, Telemonitoring, Systolic hypertension, Cerebrovascular Accident, TIA
Medical subject headings: Hypertension, Stroke, Isolated Systolic Hypertension, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03712033
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (19)

Compliance to antihypertensive regimen
Number of participants or caregivers demonstrating correct understanding of and adherence to antihypertensive regimen after phone medication titration by telemonitoring nurse
Measured: Through study completion at 6 months
Technological support requirement by participant or caregiver
Number of technological support calls to telemonitoring clinician by participant or caregiver
Measured: Assessed throughout six months program duration
Comfort and Confidence with Home Health Monitoring Questionnaire
Participant or caregiver's perception of confidence with remote hypertension management program at 1 month
Measured: At 1 month post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Participant or caregiver's perception of confidence with remote hypertension management program at 3 months
Measured: At 3 months post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Participant or caregiver's perception of confidence with remote hypertension management program at 6 months
Measured: At 6 months post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Participant or caregiver's perception of convenience of remote hypertension management program at 1 month
Measured: At 1 month post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Participant or caregiver's perception of convenience of remote hypertension management program at 3 months
Measured: At 3 months post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Participant or caregiver's perception of convenience of remote hypertension management program at 6 months
Measured: At 6 months post enrollment
Home Health Monitoring Follow-up Questionnaire
Description of Reasons for Discontinuation of telemonitoring. Only applicable if participant discontinues the telemonitoring program for any reason.
Measured: Assessed through study completion at 6 months
Difference in mean systolic blood pressure (SBP)
Comparison of mean SBP at enrollment versus three and six months
Measured: Assessed/compared at enrolment versus at three and six months.
Difference in mean diastolic blood pressure (DBP)
Comparison of mean DBP at enrollment versus at three and six months
Measured: 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
Number of days to achieve a reduction in SBP of 5 mm Hg and 10 mm Hg from mean enrolment SBP
Measured: From date of enrollment, assessed up to 6 month visit
Rate of stroke recurrence based on hospital administrative data
Rate of stroke recurrence based on hospital administrative data
Measured: Six months (180 days) - from enrolment to study completion.
Rate of stroke recurrence based on self-report
Rate of stroke recurrence based on self-report
Measured: Six months (180 days) - from enrolment to study completion.
Rate of hospital re-admission based on hospital administrative data
Rate of hospital re-admission based on hospital administrative data
Measured: Six months (180 days) - from enrolment to study completion.
Rate of hospital re-admission based on self-report
Rate of hospital re-admission based on self-report.
Measured: Six months (180 days) - from enrolment to study completion.
BP at 90-day post-study follow-up
BP as measured at follow-up visit at the Stroke Program Research Office by the study nurse.
Measured: 3 months (90 days) post study completion.
Mean length of time per Telehealth nurse phone call and mean post-call documentation time
Recorded to determine the time burden per study participant placed on the Telehealth nurse.
Measured: Six months (180 days) - from enrolment to study completion.
GP feedback on the Telehealth program
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.
Measured: At the six-month (180 day) time point. We welcome feedback from the participant's GP during the 6 month study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201810 Nov 2019

First posted19 Oct 2018
Study start1 Mar 2018
Primary completion10 Nov 2019
Study completion10 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03712033
Sponsor's protocol ID: H17-02093
Status last verified: May 2020
First submitted: 11 May 2018
Last updated: 21 May 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pendlebury ST, Rothwell PM. Prevalence, incidence, and factors associated with pre-stroke and post-stroke dementia: a systematic review and meta-analysis. Lancet Neurol. 2009 Nov;8(11):1006-18. doi: 10.1016/S1474-4422(09)70236-4. Epub 2009 Sep 24.
PubMed 19782001
Gasecki D, Kwarciany M, Nyka W, Narkiewicz K. Hypertension, brain damage and cognitive decline. Curr Hypertens Rep. 2013 Dec;15(6):547-58. doi: 10.1007/s11906-013-0398-4.
PubMed 24146223
O'Donnell MJ, Chin SL, Rangarajan S, Xavier D, Liu L, Zhang H, Rao-Melacini P, Zhang X, Pais P, Agapay S, Lopez-Jaramillo P, Damasceno A, Langhorne P, McQueen MJ, Rosengren A, Dehghan M, Hankey GJ, Dans AL, Elsayed A, Avezum A, Mondo C, Diener HC, Ryglewicz D, Czlonkowska A, Pogosova N, Weimar C, Iqbal R, Diaz R, Yusoff K, Yusufali A, Oguz A, Wang X, Penaherrera E, Lanas F, Ogah OS, Ogunniyi A, Iversen HK, Malaga G, Rumboldt Z, Oveisgharan S, Al Hussain F, Magazi D, Nilanont Y, Ferguson J, Pare G, Yusuf S; INTERSTROKE investigators. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study. Lancet. 2016 Aug 20;388(10046):761-75. doi: 10.1016/S0140-6736(16)30506-2. Epub 2016 Jul 16.
PubMed 27431356
Tu JV. Reducing the global burden of stroke: INTERSTROKE. Lancet. 2010 Jul 10;376(9735):74-5. doi: 10.1016/S0140-6736(10)60975-0. Epub 2010 Jun 17. No abstract available.
PubMed 20561674
Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.
PubMed 15053002
Biffi A, Anderson CD, Battey TW, Ayres AM, Greenberg SM, Viswanathan A, Rosand J. Association Between Blood Pressure Control and Risk of Recurrent Intracerebral Hemorrhage. JAMA. 2015 Sep 1;314(9):904-12. doi: 10.1001/jama.2015.10082.
PubMed 26325559
Wilkins K, Campbell NR, Joffres MR, McAlister FA, Nichol M, Quach S, Johansen HL, Tremblay MS. Blood pressure in Canadian adults. Health Rep. 2010 Mar;21(1):37-46.
PubMed 20426225
Cappuccio FP, Kerry SM, Forbes L, Donald A. Blood pressure control by home monitoring: meta-analysis of randomised trials. BMJ. 2004 Jul 17;329(7458):145. doi: 10.1136/bmj.38121.684410.AE. Epub 2004 Jun 11.
PubMed 15194600
Omboni S, Gazzola T, Carabelli G, Parati G. Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. J Hypertens. 2013 Mar;31(3):455-67; discussion 467-8. doi: 10.1097/HJH.0b013e32835ca8dd.
PubMed 23299557
Wood PW, Boulanger P, Padwal RS. Home Blood Pressure Telemonitoring: Rationale for Use, Required Elements, and Barriers to Implementation in Canada. Can J Cardiol. 2017 May;33(5):619-625. doi: 10.1016/j.cjca.2016.12.018. Epub 2017 Jan 3.
PubMed 28279522
Crabtree, MM, Stuart-Shor, E. Implementing Home Blood Pressure Monitoring into Usual Care. The Journal of Nurse Practitioners (2014) 10(8): 607-610.
Kerry S, Markus H, Khong T, Doshi R, Conroy R, Oakeshott P. Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital. Trials. 2008 Mar 19;9:15. doi: 10.1186/1745-6215-9-15.
PubMed 18353175
Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.
PubMed 25873044
Mandzia JL, Smith EE, Horton M, Hanly P, Barber PA, Godzwon C, Donaldson E, Asdaghi N, Patel S, Coutts SB. Imaging and Baseline Predictors of Cognitive Performance in Minor Ischemic Stroke and Patients With Transient Ischemic Attack at 90 Days. Stroke. 2016 Mar;47(3):726-31. doi: 10.1161/STROKEAHA.115.011507. Epub 2016 Feb 4.
PubMed 26846862
Coutts SB, Wein TH, Lindsay MP, Buck B, Cote R, Ellis P, Foley N, Hill MD, Jaspers S, Jin AY, Kwiatkowski B, MacPhail C, McNamara-Morse D, McMurtry MS, Mysak T, Pipe A, Silver K, Smith EE, Gubitz G; Heart, and Stroke Foundation Canada Canadian Stroke Best Practices Advisory Committee. Canadian Stroke Best Practice Recommendations: secondary prevention of stroke guidelines, update 2014. Int J Stroke. 2015 Apr;10(3):282-91. doi: 10.1111/ijs.12439. Epub 2014 Dec 23.
PubMed 25535808

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03712033
Acronym / sponsor ID: H17-02093
Conditions: Hypertension, Stroke, Blood Pressure, High, Systolic Hypertension, Transient Ischemic Attack, Cerebrovascular Accident
Keywords: Hypertension management, Stroke, Secondary Prevention, Modifiable stroke risk factor, Home blood pressure monitoring system, Telehealth, Telus Health, Telemonitoring
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Vancouver Coastal Health Research InstituteUniversity, hospital or other
Collaborators: VGH and UBC Hospital Foundation, Vancouver General Hospital
Study start: 1 Mar 2018 (actual)
Primary completion: 10 Nov 2019 (actual)
Study completion: 10 Nov 2019 (actual)
First posted: 19 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants will be selected from the Vancouver General Hospital's stroke prevention clinic.

Key inclusion criteria (9 listed)

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:
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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

19 secondary outcomes

Compliance to antihypertensive regimen
Time frame: Through study completion at 6 months
Technological support requirement by participant or caregiver
Time frame: Assessed throughout six months program duration
Comfort and Confidence with Home Health Monitoring Questionnaire
Time frame: At 1 month post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Time frame: At 3 months post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Time frame: At 6 months post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Time frame: At 1 month post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Time frame: At 3 months post enrollment
Comfort and Confidence with Home Health Monitoring Questionnaire
Time frame: At 6 months post enrollment
Home Health Monitoring Follow-up Questionnaire
Time frame: 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.
Difference in mean diastolic blood pressure (DBP)
Time frame: 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
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: 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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
Background: PubMed 19782001Pendlebury ST, Rothwell PM. Prevalence, incidence, and factors associated with pre-stroke and post-stroke dementia: a systematic review and meta-analysis. Lancet Neurol. 2009 Nov;8(11):1006-18. doi: 10.1016/S1474-4422(09)70236-4. Epub 2009 Sep 24.
Background: PubMed 24146223Gasecki D, Kwarciany M, Nyka W, Narkiewicz K. Hypertension, brain damage and cognitive decline. Curr Hypertens Rep. 2013 Dec;15(6):547-58. doi: 10.1007/s11906-013-0398-4.
Background: PubMed 27431356O'Donnell MJ, Chin SL, Rangarajan S, Xavier D, Liu L, Zhang H, Rao-Melacini P, Zhang X, Pais P, Agapay S, Lopez-Jaramillo P, Damasceno A, Langhorne P, McQueen MJ, Rosengren A, Dehghan M, Hankey GJ, Dans AL, Elsayed A, Avezum A, Mondo C, Diener HC, Ryglewicz D, Czlonkowska A, Pogosova N, Weimar C, Iqbal R, Diaz R, Yusoff K, Yusufali A, Oguz A, Wang X, Penaherrera E, Lanas F, Ogah OS, Ogunniyi A, Iversen HK, Malaga G, Rumboldt Z, Oveisgharan S, Al Hussain F, Magazi D, Nilanont Y, Ferguson J, Pare G, Yusuf S; INTERSTROKE investigators. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study. Lancet. 2016 Aug 20;388(10046):761-75. doi: 10.1016/S0140-6736(16)30506-2. Epub 2016 Jul 16.
Background: PubMed 20561674Tu JV. Reducing the global burden of stroke: INTERSTROKE. Lancet. 2010 Jul 10;376(9735):74-5. doi: 10.1016/S0140-6736(10)60975-0. Epub 2010 Jun 17. No abstract available.
Background: PubMed 15053002Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.
Background: PubMed 26325559Biffi A, Anderson CD, Battey TW, Ayres AM, Greenberg SM, Viswanathan A, Rosand J. Association Between Blood Pressure Control and Risk of Recurrent Intracerebral Hemorrhage. JAMA. 2015 Sep 1;314(9):904-12. doi: 10.1001/jama.2015.10082.
Background: PubMed 20426225Wilkins K, Campbell NR, Joffres MR, McAlister FA, Nichol M, Quach S, Johansen HL, Tremblay MS. Blood pressure in Canadian adults. Health Rep. 2010 Mar;21(1):37-46.
Background: PubMed 15194600Cappuccio FP, Kerry SM, Forbes L, Donald A. Blood pressure control by home monitoring: meta-analysis of randomised trials. BMJ. 2004 Jul 17;329(7458):145. doi: 10.1136/bmj.38121.684410.AE. Epub 2004 Jun 11.
Background: PubMed 23299557Omboni S, Gazzola T, Carabelli G, Parati G. Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. J Hypertens. 2013 Mar;31(3):455-67; discussion 467-8. doi: 10.1097/HJH.0b013e32835ca8dd.
Background: PubMed 28279522Wood PW, Boulanger P, Padwal RS. Home Blood Pressure Telemonitoring: Rationale for Use, Required Elements, and Barriers to Implementation in Canada. Can J Cardiol. 2017 May;33(5):619-625. doi: 10.1016/j.cjca.2016.12.018. Epub 2017 Jan 3.
BackgroundCrabtree, MM, Stuart-Shor, E. Implementing Home Blood Pressure Monitoring into Usual Care. The Journal of Nurse Practitioners (2014) 10(8): 607-610.
Background: PubMed 18353175Kerry S, Markus H, Khong T, Doshi R, Conroy R, Oakeshott P. Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital. Trials. 2008 Mar 19;9:15. doi: 10.1186/1745-6215-9-15.
Statistics Canada (October 13, 2016). Health Fact Sheets: Blood Pressure of Adults, 2012 to 2015Link provided by the sponsor.
Public Health Agency of Canada (2011). Tracking Heart Disease and Stroke in Canada. Stroke Highlights 2011Link provided by the sponsor.
Public Health Agency of Canada (2010). Hypertension Facts and Figures.Link provided by the sponsor.
Society of General Practitioners of British Columbia (2007). Submission to the BC Ministry of Health "Conversation on Health" Family Practice Recommendations for British Columbia's Health Care System.Link provided by the sponsor.
Hypertension Canada's 2017 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karina Villaluna, BSN, CNN(C) principal investigator

Vancouver Stroke Program (UBC) - Research Office

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Stroke, run by Vancouver Coastal Health Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants or caregivers using the home telemonitoring program (time frame: Assessed at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03712033, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.