Skip to main content
OpenTrials
Completed

NCT Number: NCT02947490

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self BP measurement

Other

BP home measurement by patient, results to GP and GP alters treatment as per usual practice

Standard care

Other

Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements

Standard BP management

Other

GP to measure BP and manage BP control

Treatment

Other

Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.

Primary outcomes

  1. Change in mean daytime/24 hour BP between baseline and follow-up using 24 hour BP recording and numbers reaching target BP

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Registry information

Official study 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)

Acronym: TEST-BP

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2016
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.