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

NCT03712033 | Completed DMC

• 1 other identifier: H17-02093
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at 6 months

Secondary Outcomes (19)

• Compliance to antihypertensive regimen

  Through study completion at 6 months

• Technological support requirement by participant or caregiver

  Assessed throughout six months program duration

• Comfort and Confidence with Home Health Monitoring Questionnaire

  At 1 month post enrollment

• Comfort and Confidence with Home Health Monitoring Questionnaire

  At 3 months post enrollment

• Comfort and Confidence with Home Health Monitoring Questionnaire

  At 6 months post enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Vancouver Coastal Health Research Institute: lead
• VGH and UBC Hospital Foundation: collaborator
• Vancouver General Hospital: collaborator

Study Sites (1)

Vancouver Stroke Program - Stroke Prevention Clinic

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (18)

• 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.

  PMID: 19782001 BACKGROUND

• 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.

  PMID: 24146223 BACKGROUND

• 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.

  PMID: 27431356 BACKGROUND

• 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.

  PMID: 20561674 BACKGROUND

• Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.

  PMID: 15053002 BACKGROUND

• 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.

  PMID: 26325559 BACKGROUND

• 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.

  PMID: 20426225 BACKGROUND

• 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.

  PMID: 15194600 BACKGROUND

• 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.

  PMID: 23299557 BACKGROUND

• 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.

  PMID: 28279522 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18353175 BACKGROUND

• 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.

  PMID: 25873044 BACKGROUND

• 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.

  PMID: 26846862 BACKGROUND

• 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.

  PMID: 25535808 BACKGROUND

• 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.

  PMID: 26551272 BACKGROUND

• 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.

  PMID: 21371282 BACKGROUND

• 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.

  PMID: 24661819 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Hypertension; Stroke; Isolated Systolic Hypertension; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Essential Hypertension; Brain Ischemia

Study Officials

• Karina Villaluna, BSN, CNN(C)

  Vancouver Stroke Program (UBC) - Research Office

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator and Manager

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: October 19, 2018
• Study Start: March 1, 2018
• Primary Completion: November 10, 2019
• Study Completion: November 10, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)