Effectiveness and cost effectiveness of self-monitoring and treatment of blood pressure in secondary prevention following stroke or transient ischaemic attack
| ISRCTN | ISRCTN86192648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86192648 |
| ClinicalTrials.gov number | NCT02947490 |
| Secondary identifying numbers | 11032 |
- Submission date
- 10/06/2015
- Registration date
- 10/06/2015
- Last edited
- 17/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Not specified |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | TEST BP |
| Study objectives | This study aims to compare different ways of measuring and managing high blood pressure after a stroke or ministroke (TIA). |
| Ethics approval(s) | 11/EE/0147 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Ambulatory BP levels and control at 6 months; Timepoint(s): ABPM at 6 months after randomisation |
| Secondary outcome measures | N/A |
| Overall study start date | 01/11/2012 |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 156; UK Sample Size: 156 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2012 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Colney
Norwich, Norfolk
NR4 7UY
United Kingdom
Sponsor information
Hospital/treatment centre
Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom
"ROR" |
https://ror.org/01wspv808 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2018 | 23/01/2019 | Yes | No |
| Results article | results | 01/01/2019 | 23/01/2019 | Yes | No |
| Other publications | economic evaluation | 01/09/2020 | 17/02/2020 | Yes | No |
Editorial Notes
17/02/2020: Publication reference added.
22/07/2019: ClinicalTrials.gov number added.
23/01/2019: Publication references added
14/06/2016: Plain English summary added.
