Effectiveness of Self-monitoring and Treatment of Blood Pressure Following Stroke or Transient Ischaemic Attack

Phase 3

Completed

• Conditions: Stroke
• Interventions: Other: Self BP measurement; Other: Standard BP management; Other: Standard Care; Other: Treatment

• Registration Number: NCT02947490
• Lead Sponsor: University of East Anglia

Brief Summary

This blinded end point RCT will recruit high risk TIA and mild stroke patients (through the emergency TIA clinics and the acute stroke services at the Norfolk \& Norwich University Hospital) who require anti-hypertensive therapy to examine the clinical and cost effectiveness of self-monitoring and self management of Blood Pressure compared to self monitoring alone and treatment as usual.

Detailed Description

Research Question: In patients with a mild/moderate stroke or TIA who require drug treatment for BP control, does BP self-monitoring with or without patient-led management using a previously agreed treatment regime result in better BP control and patient satisfaction than standard GP based management?

Planned sample size: 165 eligible participants distributed 1:1:1 between three groups. Group 1 (control) - treatment as usual (TAU). Group 2 - Self-monitoring only (Se-MO). Group 3 - Self-monitoring and self-management (Se-Man).

Primary outcome: Number reaching target Ambulatory BP levels at follow-up and change in mean Ambulatory BP levels between baseline and follow-up at 6 months.

Secondary outcomes:

Number of changes in anti-hypertensive treatment during study Side-effects profiles and adverse events BP variability Pulse Wave Velocity (PWV) changes All cause and cause-specific mortality outcome at six month Recurrent TIA or stroke Incident CVD- stroke, TIA and myocardial infarction Costs Health related quality of life assessed Quality Adjusted Life Years (EQ-5D based) Patient satisfaction and experience of the process (qualitative data)

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-05-21
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted QC: 2016-10-25
• Last Update Submitted: 2016-10-25
• Study First Posted: 2016-10-28
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Patients aged =/> 18 years old with TIA or stroke of mild/moderate severity (NIHSS =<15) who require BP management and are able and willing to undertake self BP measurement and guided alterations in therapy.

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Exclusion Criteria

• Those with terminal illness with life expectancy less than six months including end staged condition e.g. end stage COPD
• Dementia or moderate to severe cognitive impairment
• Those not receiving or expected to start anti-hypertensive therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self BP measurement and standard care	Self BP measurement	Participants in this group (Se-Mo) will be taught to use a validated British Hypertension Society (BHS) approved home BP monitor (with built in memory/printer) by the study nurse along with written information on the procedure and a copy of the BHS Home BP Monitoring DVD. Participants will be contacted before each recording week \& arrangements will be made to deliver and demonstrate the use of self BP monitor by the study nurse. Home BP monitoring will be performed over a 7 day period 3 times during the 6 month follow-up and on each occasion the patient will be given a copy of the BP results and asked to inform the GP of the results and the GP will decide if any alteration in therapy is needed.
Standard BP management	Standard BP management	Participants will continue to receive routine measurement of BP and management of treatment from their General Practitioner (GP).
Self BP measurement and standard care	Standard Care	Participants in this group (Se-Mo) will be taught to use a validated British Hypertension Society (BHS) approved home BP monitor (with built in memory/printer) by the study nurse along with written information on the procedure and a copy of the BHS Home BP Monitoring DVD. Participants will be contacted before each recording week \& arrangements will be made to deliver and demonstrate the use of self BP monitor by the study nurse. Home BP monitoring will be performed over a 7 day period 3 times during the 6 month follow-up and on each occasion the patient will be given a copy of the BP results and asked to inform the GP of the results and the GP will decide if any alteration in therapy is needed.
Self BP measurement and treatment	Treatment	Participants in this group will undergo exactly the same self BP monitoring training process as the Se-MO group and will undertake monitoring at the same time intervals. However they will be equipped with a validated BP monitor with a Bluetooth interface phone, BP values recorded by the patient will be transmitted automatically via mobile telephone to the trial coordinating centre. The data will be password protected and saved on a secure server and be available only to the trial team (study nurse \& supervising physicians). The patient would then be contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels. This will be recorded on the CRF and the GP notified of any treatment changes.
Self BP measurement and treatment	Standard Care	Participants in this group will undergo exactly the same self BP monitoring training process as the Se-MO group and will undertake monitoring at the same time intervals. However they will be equipped with a validated BP monitor with a Bluetooth interface phone, BP values recorded by the patient will be transmitted automatically via mobile telephone to the trial coordinating centre. The data will be password protected and saved on a secure server and be available only to the trial team (study nurse \& supervising physicians). The patient would then be contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels. This will be recorded on the CRF and the GP notified of any treatment changes.

Primary Outcome Measures

Name	Time	Method
Change in mean daytime/24 hour BP between baseline and follow-up using 24 hour BP recording and numbers reaching target BP	6 months

Trial Locations

Locations (1)

University of East Anglia; 🇬🇧 Norwich, Norfolk, United Kingdom