Telemonitoring and/or self-monitoring of blood pressure in hypertension (TASMINH4): protocol for a randomised controlled trial

BMC Cardiovascular Disorders

Study Protocol

Jonathan Mant¹  Marloes Franssen²  Carl Heneghan²  Richard J. McManus²  Richard Hobbs²  Andrew Farmer²  Rafael Perera-Salazar²  Ly-Mee Yu²  Claire Schwartz²  Emma Ogburn²  Siobhan Milner³  Mark Monahan³  Una Martin³  Susan Jowett³  Sabrina Grant³  James Hodgkinson³  Sheila Greenfield³ 

[1] Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK;Nuffield Department of Primary Care, Oxford University, Oxford, UK;Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK;

关键词: Hypertension;    Self-monitoring;    Telemonitoring;    Primary care;   

DOI  :  10.1186/s12872-017-0494-5

 received in 2016-12-10, accepted in 2017-02-07,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundSelf-monitoring of hypertension is associated with lower systolic blood pressure (SBP). However, evidence for the use of self-monitoring to titrate antihypertensive medication by physicians is equivocal. Furthermore, there is some evidence for the efficacy of telemonitoring in the management of hypertension but it is not clear what this adds over and above self-monitoring. This trial aims to evaluate whether GP led antihypertensive titration using self-monitoring results in lower SBP compared to usual care and whether telemonitoring adds anything to self-monitoring alone.Methods/DesignThis will be a pragmatic primary care based, unblinded, randomised controlled trial of self-monitoring of BP with or without telemonitoring compared to usual care. Eligible patients will have poorly controlled hypertension (>140/90 mmHg) and will be recruited from primary care. Participants will be individually randomised to either usual care, self-monitoring alone, or self-monitoring with telemonitoring. The primary outcome of the trial will be difference in clinic SBP between intervention and control groups at 12 months adjusted for baseline SBP, gender, BP target and practice. At least 1110 patients will be sufficient to detect a difference in SBP between self-monitoring with or without telemonitoring and usual care of 5 mmHg with 90% power with an adjusted alpha of 0.017 (2-sided) to adjust for all three pairwise comparisons. Other outcomes will include adherence of anti-hypertensive medication, lifestyle behaviours, health-related quality of life, and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative sub study will gain insights into the views, experiences and decision making processes of patients and health care professionals focusing on the acceptability of self-monitoring and telemonitoring in the routine management of hypertension.DiscussionThe results of the trial will be directly applicable to primary care in the UK. If successful, self-monitoring of BP in people with hypertension would be applicable to hundreds of thousands of individuals in the UK.Trial registrationISRCTN 83571366. Registered 17 July 2014

【 授权许可】

CC BY   
© The Author(s). 2017