Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial

Richard J McManus, Jonathan Mant, Marloes Franssen, Alecia Nickless, Claire Schwartz, James Hodgkinson, Peter Bradburn, Andrew Farmer, Sabrina Grant, Sheila M Greenfield, Carl Heneghan, Susan Jowett, Una Martin, Siobhan Milner, Mark Monahan, Sam Mort, Emma Ogburn, Rafael Perera-Salazar, Syed Ahmar Shah, Ly-Mee Yu, Lionel Tarassenko, F D Richard Hobbs, Brendan Bradley, Chris Lovekin, David Judge, Luis Castello, Maureen Dawson, Rebecca Brice, Bethany Dunbabin, Sophie Maslen, Heather Rutter, Mary Norris, Lauren French, Michael Loynd, Pippa Whitbread, Luisa Saldana Ortaga, Irene Noel, Karen Madronal, Julie Timmins, Peter Bradburn, Lucy Hughes, Beth Hinks, Sheila Bailey, Sue Read, Andrea Weston, Somi Spannuth, Sue Maiden, Makiko Chermahini, Ann McDonald, Shelina Rajan, Sue Allen, Brenda Deboys, Kim Fell, Jenny Johnson, Helen Jung, Rachel Lister, Ruth Osborne, Amy Secker, Irene Qasim, Kirsty William, Abi Harris, Susan Zhao, Elaine Butcher, Pauline Darbyshire, Sarah Joshi, Jon Davies, Claire Talbot, Eleanor Hoverd, Linda Field, Tracey Adcock, Julia Rooney, Nina Cooter, Aaron Butler, Naomi Allen, Maria Abdul-Wahab, Kathryn McNicholas, Lara Peniket, Kate Dodd, Julie Mugurza, Richard Baskerville, Rakshan Syed, Clare Bailey, Jill Adams, Paul Uglow, Neil Townsend, Alison Macleod, Charlotte Hawkins, Suparna Behura, Jonathan Crawshaw, Robin Fox, Waleed Doski, Martin Aylward, Christine A'Court, David Rapley, Jo Walsh, Paul Batra, Ana Seoane, Sluti Mukherjee, Jonathan Dixon, Peter Arthur, Karen Sutcliffe, Costas Paschallides, Richard Woof, Peter Winfrey, Matthew Clark, Roya Kamali, Paul Thomas, David Ebbs, Liz Mather, Andre Beattie, Karim Ladha, Larisa Smondulak, Surinder Jemahl, Peter Hickson, Liam Stevens, Tony Crockett, David Shukla, Ian Binnian, Paul Vinson, Nigel DeKare-Silver, Ramila Patel, Ivor Singh, Louise Lumley, Glennis Williams, Mark Webb, Jack Bambrough, Neetul Shah, Hergeven Dosanjh, Frank Spannuth, Carolyn Paul, Jude Ganesegaram, Laurie Pike, Vijaysundari Maheswaran, Farah Paruk, Stephen Ford, Vineeta Verma, Kate Milne, Farhana Lockhat, Jennifer Ferguson, Anne-Marie Quirk, Hugo Wilson, David Copping, Sam Bajallan, Simria Tanvir, Faheem Khan, Tom Alderson, Amar Ali, Richard Young, Umesh Chauhan, Lindsey Crockett, Louise McGovern, Claire Cubitt, Simon Weatherill, Abdul Tabassum, Philip Saunders, Naresh Chauhan, Samantha Johnson, Jo Walsh, Inderjit Marok, Rajiv Sharma, William Lumb, John Tweedale, Ian Smith, Lawrence Miller, Tanveer Ahmed, Mark Sanderson, Claire Jones, Peter Stokell, Matthew J Edwards, Andrew Askey, Jason Spencer, Kathryn Morgan, Kyle Knox, Robert Baker, Crispin Fisher, Rachel Halstead, Neil Modha, David Buckley, Catherine Stokell, John Gerald McCabe, Jennifer Taylor, Helen Nutbeam, Richard Smith, Christopher MacGregor, Sam Davies, Mark Lindsey, Simon Cartwright, Jonathan Whittle, Julie Colclough, Alison Crumbie, Nicholas Thomas, Vattakkatt Premchand, Rafia Hamid, Zishan Ali, John Ward, Philip Pinney, Stephen Thurston, Tina Banerjee

Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. 1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.