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

Stroke Clinical Trial

— TEST-BP  

Official title:

Trial of the Effectiveness and Cost Effectiveness of Self-monitoring and Treatment of Blood Pressure in Secondary Prevention Following Stroke or Transient Ischaemic Attack (TIA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947490
• Other study ID #: JPotter
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2015
• Last updated: October 25, 2016
• Start date: September 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke

Intervention

Other:
• Self BP measurement
BP home measurement by patient, results to GP and GP alters treatment as per usual practice
• Standard Care
Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements
• Standard BP management
GP to measure BP and manage BP control
• Treatment
Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.

Locations

Country	Name	City	State
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean daytime/24 hour BP between baseline and follow-up using 24 hour BP recording and numbers reaching target BP		6 months	No