Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study)

Sonia Ben Hafaiedh, Yosra Ben Daya, Amina Hadjer Radoui, Mohamed Bouchoucha, Rabie Razgallah, Semir Nouira, Sonia Ben Hafaiedh, Yosra Ben Daya, Amina Hadjer Radoui, Mohamed Bouchoucha, Rabie Razgallah, Semir Nouira

Abstract

Background: Despite the availability of effective treatment, the control of hypertension remains insufficient. Telemonitoring in the management of hypertension would be an effective way to improve blood pressure control.

Objective: The aim of our study will be to evaluate the effects of telemonitoring with antihypertensive treatment titration on blood pressure control in Tunisian patients with hypertension.

Methods: Our trial will be a prospective, rater-blinded randomized controlled trial carried out with primary care physicians in the Sahel region of Tunisia. Patients will be eligible for enrollment if they are aged over 35 years, are newly diagnosed with hypertension, or are known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring arm or usual care arm. The telemonitoring arm will involve a weekly telephone call for the collection of the home blood pressure measurements, therapeutic education, and treatment compliance assessment as well as a monthly call for treatment titration and a side effect check. Randomization will be done via the use of an interactive web responsive system, and patients will be stratified by investigation center. Neither participants nor investigators will be masked to the group assignments. The primary outcome will be the change in mean 24-hour systolic blood pressure from baseline to the 6-month follow-up in the 2 groups. All randomized patients who attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis.

Results: Recruitment to the trial started in July 2020. The study was initiated with 17 primary care physicians. We expect the inclusion period to last for approximately 6 months. We expect to complete data collection by the end of 2021 and plan to disseminate the results subsequently.

Conclusions: The HOROSCOPE (Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Randomized Controlled Prospective Trial) study will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring and self-monitoring in a Tunisian population of patients with hypertension who consult primary care physicians.

Trial registration: ClinicalTrials.gov NCT04607239; https://ichgcp.net/clinical-trials-registry/NCT04607239.

International registered report identifier (irrid): DERR1-10.2196/26184.

Keywords: ambulatory blood pressure monitoring; arterial hypertension; primary care; randomized controlled trial; telemonitoring.

Conflict of interest statement

Conflicts of Interest: None declared.

©Sonia Ben Hafaiedh, Yosra Ben Daya, Amina Hadjer Radoui, Mohamed Bouchoucha, Rabie Razgallah, Semir Nouira. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 01.03.2022.

Figures

Figure 1
Figure 1
Participant flow throughout the study. ABPM: ambulatory blood pressure monitoring; BP: blood pressure; CRA: clinical research associate; SF-12: 12-Item Short Form Survey.

References

    1. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, Buchbinder R, Bull F, Burnett RT, Byers TE, Calabria B, Carapetis J, Carnahan E, Chafe Z, Charlson F, Chen H, Chen JS, Cheng AT, Child JC, Cohen A, Colson KE, Cowie BC, Darby S, Darling S, Davis A, Degenhardt L, Dentener F, Des Jarlais DC, Devries K, Dherani M, Ding EL, Dorsey ER, Driscoll T, Edmond K, Ali SE, Engell RE, Erwin PJ, Fahimi S, Falder G, Farzadfar F, Ferrari A, Finucane MM, Flaxman S, Fowkes FGR, Freedman G, Freeman MK, Gakidou E, Ghosh S, Giovannucci E, Gmel G, Graham K, Grainger R, Grant B, Gunnell D, Gutierrez HR, Hall W, Hoek HW, Hogan A, Hosgood HD, Hoy D, Hu H, Hubbell BJ, Hutchings SJ, Ibeanusi SE, Jacklyn GL, Jasrasaria R, Jonas JB, Kan H, Kanis JA, Kassebaum N, Kawakami N, Khang Y, Khatibzadeh S, Khoo J, Kok C, Laden F, Lalloo R, Lan Q, Lathlean T, Leasher JL, Leigh J, Li Y, Lin JK, Lipshultz SE, London S, Lozano R, Lu Y, Mak J, Malekzadeh R, Mallinger L, Marcenes W, March L, Marks R, Martin R, McGale P, McGrath J, Mehta S, Mensah GA, Merriman TR, Micha R, Michaud C, Mishra V, Hanafiah KM, Mokdad AA, Morawska L, Mozaffarian D, Murphy T, Naghavi M, Neal B, Nelson PK, Nolla JM, Norman R, Olives C, Omer SB, Orchard J, Osborne R, Ostro B, Page A, Pandey KD, Parry CDH, Passmore E, Patra J, Pearce N, Pelizzari PM, Petzold M, Phillips MR, Pope D, Pope CA, Powles J, Rao M, Razavi H, Rehfuess EA, Rehm JT, Ritz B, Rivara FP, Roberts T, Robinson C, Rodriguez-Portales JA, Romieu I, Room R, Rosenfeld LC, Roy A, Rushton L, Salomon JA, Sampson U, Sanchez-Riera L, Sanman E, Sapkota A, Seedat S, Shi P, Shield K, Shivakoti R, Singh GM, Sleet DA, Smith E, Smith KR, Stapelberg NJC, Steenland K, Stöckl H, Stovner LJ, Straif K, Straney L, Thurston GD, Tran JH, Van Dingenen R, van Donkelaar A, Veerman JL, Vijayakumar L, Weintraub R, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams W, Wilson N, Woolf AD, Yip P, Zielinski JM, Lopez AD, Murray CJL, Ezzati M, AlMazroa MA, Memish ZA. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224–2260. doi: 10.1016/S0140-6736(12)61766-8. S0140-6736(12)61766-8
    1. Rodgers A, Ezzati M, Hoorn SV, Lopez AD, Lin RB, Murray CJL, Comparative Risk Assessment Collaborating Group Distribution of major health risks: findings from the Global Burden of Disease study. PLoS Med. 2004 Oct;1(1):e27. doi: 10.1371/journal.pmed.0010027.
    1. Falaschetti E, Mindell J, Knott C, Poulter N. Hypertension management in England: a serial cross-sectional study from 1994 to 2011. Lancet. 2014 May 31;383(9932):1912–1919. doi: 10.1016/S0140-6736(14)60688-7.S0140-6736(14)60688-7
    1. McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett S, Little P, Penaloza C, Schwartz C, Shackleford H, Shovelton C, Varghese J, Williams B, Hobbs FDR, Gooding T, Morrey I, Fisher C, Buckley D. Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. JAMA. 2014 Aug 27;312(8):799–808. doi: 10.1001/jama.2014.10057.1899205
    1. Duan Y, Xie Z, Dong F, Wu Z, Lin Z, Sun N, Xu J. Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. J Hum Hypertens. 2017 Jul;31(7):427–437. doi: 10.1038/jhh.2016.99.jhh201699
    1. McKinstry B, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, Sheikh A, Krishan A, Stoddart A, Padfield P. Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial. BMJ. 2013 May 24;346:f3030. doi: 10.1136/bmj.f3030.
    1. Tucker KL, Sheppard JP, Stevens R, Bosworth HB, Bove A, Bray EP, Earle K, George J, Godwin M, Green BB, Hebert P, Hobbs FDR, Kantola I, Kerry SM, Leiva A, Magid DJ, Mant J, Margolis KL, McKinstry B, McLaughlin MA, Omboni S, Ogedegbe O, Parati G, Qamar N, Tabaei BP, Varis J, Verberk WJ, Wakefield BJ, McManus RJ. Self-monitoring of blood pressure in hypertension: A systematic review and individual patient data meta-analysis. PLoS Med. 2017 Sep 19;14(9):e1002389. doi: 10.1371/journal.pmed.1002389.PMEDICINE-D-16-03401
    1. McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P, Williams B, Hobbs FDR. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet. 2010 Jul 17;376(9736):163–172. doi: 10.1016/S0140-6736(10)60964-6.S0140-6736(10)60964-6
    1. McManus RJ, Mant J, Franssen M, Nickless A, Schwartz C, Hodgkinson J, Bradburn P, Farmer A, Grant S, Greenfield SM, Heneghan C, Jowett S, Martin U, Milner S, Monahan M, Mort S, Ogburn E, Perera-Salazar R, Shah SA, Yu L, Tarassenko L, Hobbs FDR, TASMINH4 investigators Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial. Lancet. 2018 Mar 10;391(10124):949–959. doi: 10.1016/S0140-6736(18)30309-X. S0140-6736(18)30309-X
    1. Monahan M, Jowett S, Nickless A, Franssen M, Grant S, Greenfield S, Hobbs FDR, Hodgkinson J, Mant J, McManus RJ. Cost-effectiveness of telemonitoring and self-monitoring of blood pressure for antihypertensive titration in primary care (TASMINH4) Hypertension. 2019 Jun;73(6):1231–1239. doi: 10.1161/HYPERTENSIONAHA.118.12415.
    1. Marzouk-Aissi W, Alaya-Bouafif NB, Bougatef S, Traissac P, Delpeuch F, Romdhane HB. Prévalence et déterminants de l’hypertension artérielle chez les adultes tunisiens, Tunisie. Rev Epidemiol Sante Publique. 2012 Sep;60(Supplement 2):S101. doi: 10.1016/j.respe.2012.06.210.
    1. Ware Jr J, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. Williams B, Mancia G, Spiering W, Rosei EA, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I, ESC Scientific Document Group 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 01;39(33):3021–3104. doi: 10.1093/eurheartj/ehy339.5079119
    1. Liu M, Li Y, Wei FF, Zhang L, Han JL, Wang JG. Is blood pressure load associated, independently of blood pressure level, with target organ damage? J Hypertens. 2013 Sep;31(9):1812–1818. doi: 10.1097/HJH.0b013e3283624f9b.
    1. Michel Y, Brandstatter H, Gaspoz JM, Muggli F, Pechère-Bertschi A. [Interpretation of 24h ambulatory blood pressure monitoring by primary care physicians] Rev Med Suisse. 2009 Sep 23;5(218):1876–1880.
    1. Bloomfield D, Park A. Night time blood pressure dip. World J Cardiol. 2015 Jul 26;7(7):373–376. doi: 10.4330/wjc.v7.i7.373.
    1. Spieth PM, Kubasch AS, Penzlin AI, Illigens BMW, Barlinn K, Siepmann T. Randomized controlled trials - a matter of design. Neuropsychiatr Dis Treat. 2016 Jun 10;12:1341–1349. doi: 10.2147/NDT.S101938. ndt-12-1341

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