TEC4Home Stroke - Feasibility of Home Telemonitoring Technology in Managing Hypertension Among Stroke/TIA Patients
NCT ID: NCT03712033
Last Updated: 2020-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2018-03-01
2019-11-10
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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VGH and UBC Hospital Foundation
OTHER
Vancouver General Hospital
OTHER
Vancouver Coastal Health Research Institute
OTHER
Responsible Party
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Karina Villaluna Murray
Clinical Research Coordinator and Manager
Principal Investigators
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Karina Villaluna, BSN, CNN(C)
Role: PRINCIPAL_INVESTIGATOR
Vancouver Stroke Program (UBC) - Research Office
Locations
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Vancouver Stroke Program - Stroke Prevention Clinic
Vancouver, British Columbia, Canada
Countries
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References
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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.
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.
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.
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.
Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.
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.
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.
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.
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.
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.
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.
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.
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.
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.
SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.
Benavente OR, White CL, Pearce L, Pergola P, Roldan A, Benavente MF, Coffey C, McClure LA, Szychowski JM, Conwit R, Heberling PA, Howard G, Bazan C, Vidal-Pergola G, Talbert R, Hart RG; SPS3 Investigators. The Secondary Prevention of Small Subcortical Strokes (SPS3) study. Int J Stroke. 2011 Apr;6(2):164-75. doi: 10.1111/j.1747-4949.2010.00573.x. Epub 2011 Jan 26.
Lewis BL, Pearce LA, Field TS, White CL, Benavente OR; SPS3 Investigators. The relevance of living supports on antiplatelet adherence and trial participation: the SPS3 trial. Int J Stroke. 2014 Jun;9(4):443-8. doi: 10.1111/ijs.12267. Epub 2014 Mar 24.
Related Links
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Statistics Canada (October 13, 2016). Health Fact Sheets: Blood Pressure of Adults, 2012 to 2015
Public Health Agency of Canada (2011). Tracking Heart Disease and Stroke in Canada. Stroke Highlights 2011
Public Health Agency of Canada (2010). Hypertension Facts and Figures.
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.
Hypertension Canada's 2017 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults.
Other Identifiers
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H17-02093
Identifier Type: -
Identifier Source: org_study_id
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