StrokePhase 3TEST-BPNCT02947490
Effectiveness of Self-monitoring and Treatment of Blood Pressure Following Stroke or Transient Ischaemic Attack
A Phase 3 study testing Self BP measurement, Standard BP management and Treatment in people with Stroke, run by University of East Anglia at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Self BP measurement, Standard BP management and Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR4 7TJ
About this study
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)
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.
Read the detailed 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)
- Conditions
- Stroke
- Being tested
- Self BP measurement, Standard Care, Standard BP management, Treatment
- Keywords
- Blood pressure monitoring, self BP monitoring, self BP management
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self BP measurementOther
BP home measurement by patient, results to GP and GP alters treatment as per usual practice
Standard CareOther
Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements
Standard BP managementOther
GP to measure BP and manage BP control
TreatmentOther
Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.
| Study group | Role | What they receive |
|---|---|---|
| Standard BP management | Sham comparator | Participants will continue to receive routine measurement of BP and management of treatment from their General Practitioner (GP). Receives: Other: Standard BP management |
| Self BP measurement and standard care | Placebo comparator | Participants in this group (Se-Mo) will be taught to use a validated British Hypertension Society (BHS) approved home BP monitor (with built in memory/printer) by the study nurse along with written information on the procedure and a copy of the BHS Home BP Monitoring DVD. Participants will be contacted before each recording week \& arrangements will be made to deliver and demonstrate the use of self BP monitor by the study nurse. Home BP monitoring will be performed over a 7 day period 3 times during the 6 month follow-up and on each occasion the patient will be given a copy of the BP results and asked to inform the GP of the results and the GP will decide if any alteration in therapy is needed. Receives: Other: Self BP measurement; Other: Standard Care |
| Self BP measurement and treatment | Active comparator | Participants in this group will undergo exactly the same self BP monitoring training process as the Se-MO group and will undertake monitoring at the same time intervals. However they will be equipped with a validated BP monitor with a Bluetooth interface phone, BP values recorded by the patient will be transmitted automatically via mobile telephone to the trial coordinating centre. The data will be password protected and saved on a secure server and be available only to the trial team (study nurse \& supervising physicians). The patient would then be contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels. This will be recorded on the CRF and the GP notified of any treatment changes. Receives: Other: Standard Care; Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean daytime/24 hour BP between baseline and follow-up using 24 hour BP recording and numbers reaching target BP
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startSep 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Potter, DM FRCP, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947490
- Sponsor's protocol ID
- JPotter
- Acronym
- TEST-BP
- Status last verified
- Oct 2016
- First submitted
- 21 May 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02947490
- Acronym / sponsor ID
- TEST-BP / JPotter
- Conditions
- Stroke
- Keywords
- Blood pressure monitoring, self BP monitoring, self BP management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard BP management | Sham comparator | Other: Standard BP managementParticipants will continue to receive routine measurement of BP and management of treatment from their General Practitioner (GP). |
| Self BP measurement and standard care | Placebo comparator | Other: Self BP measurement, Other: Standard CareParticipants in this group (Se-Mo) will be taught to use a validated British Hypertension Society (BHS) approved home BP monitor (with built in memory/printer) by the study nurse along with written information on the procedure and a copy of the BHS Home BP Monitoring DVD. Participants will be contacted before each recording week \& arrangements will be made to deliver and demonstrate the use of self BP monitor by the study nurse. Home BP monitoring will be performed over a 7 day period 3 times during the 6 month follow-up and on each occasion the patient will be given a copy of the BP results and asked to inform the GP of the results and the GP will decide if any alteration in therapy is needed. |
| Self BP measurement and treatment | Active comparator | Other: Standard Care, Other: TreatmentParticipants in this group will undergo exactly the same self BP monitoring training process as the Se-MO group and will undertake monitoring at the same time intervals. However they will be equipped with a validated BP monitor with a Bluetooth interface phone, BP values recorded by the patient will be transmitted automatically via mobile telephone to the trial coordinating centre. The data will be password protected and saved on a secure server and be available only to the trial team (study nurse \& supervising physicians). The patient would then be contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels. This will be recorded on the CRF and the GP notified of any treatment changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self BP measurementBP home measurement by patient, results to GP and GP alters treatment as per usual practice | Other | Self BP measurement and standard care |
| Standard CareSelf BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements | Other | Self BP measurement and standard care, Self BP measurement and treatment |
| Standard BP managementGP to measure BP and manage BP control | Other | Standard BP management |
| TreatmentContacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels. | Other | Self BP measurement and treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Potter, DM FRCP principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self BP measurement, Standard BP management and Treatment in people with Stroke, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.