Hypertension Circulatory System
Conditions
Interventions
Current interventions as of 27/05/2016:
370 patients will be randomised to usual care (UC) and 740 randomised to self-monitoring (370 self-monitoring alone and 370 telemonitoring).
1. Self-monitorin
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic BP (mean of 2nd and 3rd BP readings); Timepoint(s): 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/06/2016: 1. Systolic and diastolic BP; Timepoint(s): 6 months and 12 months 2. Costs, health sector resource use, and acceptability; Timepoint(s): 12 months 3. MARS adherence questionnaires and prescribing data; Timepoint(s): 12 months 4. Questionnaire data on lifestyle factors; Timepoint(s): 12 months 5. Comparison between trial outcome data and that from clinical databases; Timepoint(s): 12 months Previous secondary outcome measures: 1. Systolic and diastolic BP; Timepoint(s): 6 months and 12 months 2. Costs, health sector resource use, and acceptability; Timepoint(s): 24 months 3. MARS adherence questionnaires and prescribing data; Timepoint(s): 12 months 4. Questionnaire data on lifestyle factors; Timepoint(s): 12 months 5. Comparison between trial outcome data and that from clinical databases; Timepoint(s): 24 months | — |
Countries
United Kingdom
Contacts
Public ContactMarloes Franssen
Outcome results
None listed