Telemonitoring and/or self-monitoring in hypertension (TASMINH4): a randomised controlled trial

niversity of Oxford (UK)0 个研究点目标入组 1,100 人开始时间: 2014年7月17日最近更新: 2018年5月7日

适应症

试验速览

•1. Participant is willing and able to give informed consent for participation in the trial
•2. Male or female, aged 35 years or above
•3. On practice hypertension register, not already taking more than 3 anti-hypertensive agents and above clinic target BP (i.e. =140/90 mmHg) at baseline (mean of 2nd/ 3rd readings)
•4. Stable dose of current antihypertensive medication for at least four weeks prior to trial entry
•5. In the Investigator?s' opinion, is able and willing to comply with all trial requirements or has a carer able to help sufficiently (e.g. in the case of physical issues with self-monitoring)
•6. Willing to allow his or her General Practitioner to be notified of participation in the trial

•1. BP below target at baseline (i.e. <140/90 mmHg on clinic measurement at baseline visit)
•2. Already taking more than 3 anti-hypertensive agents
•3. Orthostatic hypotension: more than 20mmHg systolic drop after standing for 1 minute
•4. Diagnosed atrial fibrillation
•5. Unwilling to self-monitor
•6. BP managed outside of primary care (including secondary hypertension)
•7. Unable to provide consent
•8. Dementia or score over 10 on the short orientation memory concentration test (and with no carer support)
•9. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
•10. The partner or spouse of an individual already randomised in the trial
•11. Chronic Kidney Disease (CKD) Grade 4 or worse; any grade of CKD with proteinuria
•12. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant?s ability to participate in the trial (e.g. terminal illness, house bound and unable to attend baseline and follow up clinics)
•13. Participants who have participated in another research trial involving an antihypertensive medication in the past 4 weeks

发起方

niversity of Oxford (UK)