Blood pressure monitoring in people who have had a stroke or transient ischaemic attack (TIA) Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
The intervention is based around stroke/TIA survivors measuring their blood pressure at home. In studies where most people haven’t had a stroke/TIA, measuring blood pressure at home, with adjustment o
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Previous history of stroke and/or specialist confirmed TIA at least one month before randomisation 4. Baseline systolic blood pressure > 130mmHg (mean of 2nd and 3rd readings) 5. Willing and able to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1. Diagnosis of dementia (Clinical Code) 2. Score over 10 on the short orientation memory concentration test 3. Any other significant disease or disorder which, in the opinion of the Investigator, may put the participants at risk because of participation in the trial 4. Pregnancy 5. BP > 180/110mmHg at baseline (to be referred to GP but could be subsequently rescreened if < 180/110mmHg) 6. More than three antihypertensives 7. Unwilling to self-monitor 8. Receiving care for blood pressure by a specialist rather than a primary care physician 9. Stage 4 CKD or worse – i.e.: eGFR less than 30 mL/min/1.73 m2 (as these persons are more likely to be managed by specialists, are more prone to Acute Kidney Injury and/or hyperkalemia and less responsive to certain antihypertensives?) 10. Diagnosed atrial fibrillation 11. Orthostatic hypotension: more than 20mmHg systolic drop after standing for 1 minute. Not relevant if participant unable to stand 12. Participation in other studies that concern hypertension and/or adjustment of antihypertensive medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in systolic blood pressure (SBP) at 1 year comparing intervention and control groups, using the mean of the 2nd and 3rd readings and adjusted for baseline systolic blood pressure and other covariates | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.1. Diastolic BP at 1 year: mean of the second and third readings, adjusted for baseline DBP 1.2. Systolic and diastolic BP at 6months: mean of the second and third readings, adjusted for baseline BP 1.3. Multiple SBP and DBP measurements (mean of second – sixth measurements) adjusted for baseline BP at 6 and 12 months 1.4. Proportion controlled below target using mean of 2nd/3rd readings for SBP and DBP at 6 and 12 months adjusted for baseline 2. Quality of life and anxiety levels measured using EQ-5D 5L and STA1:Y-6 item participant-completed questionnaires and healthcare costs during the trial at 12 months adjusted for baseline 3. Healthcare system and social care use/costs plus patient out of pocket expenses during the trial Tertiary outcome measures: 1. Adverse events, hospital admissions and cardiovascular events between baseline and 12 months, measured using participant-reported events at a 12-month follow-up assessment and review of participant medical notes. 2. Patient enablement or beliefs about medicine measured using patient-completed questionnaires between baseline and 12 months Process evaluation: 1. How trial recruitment and intervention training is understood by patients, carers and recruiters assessed using thematic and/or conversation analysis of audio recordings of recruitment and consent appointments collected during trial recruitment 2. How the intervention is implemented in daily life and what are the barriers and facilitators for patients/carer assessed using thematic analysis of observations and interviews with patients and carers during the trial 3. What the barriers and facilitators for GPs and other staff are for implementing the intervention assessed using thematic analysis of interviews with professionals during the trial 4. Adherence to antihypertensive medication at 6 and 12 months assessed using participant-completed Medication Adherence Rating Scale Questionnaire at baseline and 12 months 5. Intervention fidelity (if patients ran | — |
Countries
England, Ireland, Scotland, United Kingdom
Outcome results
None listed