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
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
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