Condition category
Circulatory System
Date applied
10/06/2015
Date assigned
10/06/2015
Last edited
14/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to compare different ways of measuring and managing high blood pressure after a stroke or ministroke (TIA). At present, decisions about whether blood pressure levels need to be treated and therefore how much and what blood pressure lowering treatment to take are usually based on blood pressure levels taken at the hospital clinics or GP surgeries. It is not known whether self-monitoring of blood pressure with some guidance and adjustment of medication would improve the blood pressure control and hence reduce the risk of stroke in people who have had a TIA and milder stroke. The aim of this study is to test whether self-monitoring of blood pressure and supervised self-management of treatment results in better blood pressure control and greater patient satisfaction.

Who can participate?
Patients aged 55 and over with TIA or stroke who require blood pressure management

What does the study involve?
Participants are randomly allocated to one of three groups. The first group monitor their blood pressure and manage their own treatment changes with the study team’s support. The second group monitor their blood pressure but the results are relayed to a participant's GP, with GP-led treatment changes. The third group undergoes standard GP clinic blood pressure measurements. All the participants’ blood pressure levels are assessed after 6 months and they are asked how they feel about home monitoring of blood pressure in terms of how easy and practical it is, what concerns they may have and how they feel about altering their treatment under supervision. This study also assesses whether blood pressure self-monitoring represents good value for money for the NHS and taxpayers.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Norfolk and Norwich University Hospital NHS Trust (UK)

When is the study starting and how long is it expected to run for?
November 2012 to September 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
John Potter

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Potter

ORCID ID

Contact details

Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11032

Study information

Scientific title

Trial of the effectiveness and cost effectiveness of selfmonitoring and treatment of blood pressure in secondary prevention following stroke or transient ischaemic attack

Acronym

TEST BP

Study hypothesis

This study aims to compare different ways of measuring and managing high blood pressure after a stroke or ministroke (TIA).

Ethics approval

11/EE/0147

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Stroke; Subtopic: Primary Care, Rehabilitation; Disease: Therapy type

Intervention

1. Self monitoring of Blood Pressure (SBPM) with supervised patient lead treatment changes
2. SBPM only with GP lead treatment changes
3. Standard GP lead control and no SBPM

Follow Up Length: 6 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Ambulatory BP levels and control at 6 months; Timepoint(s): ABPM at 6 months after randomisation

Secondary outcome measures

N/A

Overall trial start date

01/11/2012

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >= 55 years
2. Patients with TIA or stroke of mild/moderate severity (NIHSS =<15)
3. Patients that require BP management
4. Patients able and willing to undertake self BP measurement and guided alterations in therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 156; UK Sample Size: 156

Participant exclusion criteria

1. Patients with terminal illness with life expectancy less than six months including end staged condition e.g. end stage COPD Dementia
2. Patients with moderate to severe cognitive impairment
3. Patients not receiving or expected to start antihypertensive therapy

Recruitment start date

01/11/2012

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital NHS Trust
Colney Lane Colney
Norwich, Norfolk
NR4 7UY
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospital NHS Trust

Sponsor details

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/06/2016: Plain English summary added.