StrokePhase 3NCT00514800
Home Blood Pressure Monitoring Trial
A Phase 3 study testing Intervention - a validated home BP monitor and support from the specialist nurse in people with Stroke and Ischemic Attack, Transient, run by St George's, University of London at 3 sites in United Kingdom.
Trial summary
Design: Community based randomised trial with follow up after 12 months Participants: 360 patients admitted with stroke or TIA within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stroke, Ischemic Attack, Transient
- What is being tested?
- Intervention - a validated home BP monitor and support from the specialist nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Mar 2007to Apr 2009
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stroke or TIA in last 9 months
- Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication
Who cannot join
- Severe illness likely to dominate pattern of care
- Already using home blood pressure monitor
- Non-English speaking
- Severe cognitive impairment (AMTS<7)
- Known secondary hypertension
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St. Helier NHS Trust
Carshalton, Surrey, SM5 1AA
Mayday University Hospital
Croydon, Surrey, CR7 7YE
St. George's Healthcare Trust
London, London, SW17 0RE
About this study
Official title: Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital
Design: Community based randomised trial with follow up after 12 months Participants: 360 patients admitted with stroke or TIA within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. All patients will be visited by the specialist nurse at home at baseline when she will measure their BP and administer a questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another researcher blind as to whether the patient is in intervention or control group.
Intervention: Intervention patients will be given a validated home BP monitor and support from the specialist nurse. Control patients will continue with usual care (BP monitoring by their practice).
Read more
Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost effectiveness: Incremental cost of the intervention to the NHS and incremental cost per quality adjusted life year gained.
Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood pressure after 12 months compared with usual GP care
Read the detailed description
High blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate. Home blood pressure monitoring may increase patients' involvement in their care, increase compliance, and reduce the need for patients to attend their GP if blood pressure is adequately controlled. However the value of home monitoring to improve BP control is unclear and there is now a window of opportunity for evaluation before their use becomes widespread in the UK. Furthermore its use in stroke patients presents unique challenges relating to the consequent neurological disability.
- Conditions
- Stroke, Ischemic Attack, Transient
- Being tested
- Intervention - a validated home BP monitor and support from the specialist nurse, Control - usual care (BP monitoring by their practice)
- Keywords
- Home monitoring, Primary care, Hypertension, TIA
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention - a validated home BP monitor and support from the specialist nurseBehavioural
Control - usual care (BP monitoring by their practice)Behavioural
Patients will not receive a blood pressure monitor and will continue with usual GP care for hypertension management.
GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will be given a home blood pressure monitor and taught how to use it and how to respond to the readings using a standardised protocol and blood pressure targets. The study nurse will follow up patients at home after a month with additional telephone support according to a defined protocol. Patients will consult their own GP for medication changes when above target.
GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings. Receives: Behavioral: Intervention - a validated home BP monitor and support from the specialist nurse |
| Control | Active comparator | Not described Receives: Behavioral: Control - usual care (BP monitoring by their practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in systolic blood pressure taken by study team at home visit
Measured: 12 months
Secondary outcomes (6)
Reduction in diastolic blood pressure taken by study team at home visit
Measured: 12 months
Reduction in SBP and DBP taken by study team at home visit
Measured: 6 months
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
Measured: 12 months
EQ-5D
Measured: 12 months
FEAR
Measured: 12 months
Incremental cost of the intervention to the NHS and cost per QALY
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startMar 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- The Stroke Association, United Kingdom
- Investigators
- Sally Kerry, MSc, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514800
- Sponsor's protocol ID
- 07.0002
- Other IDs
- TSA 2006/05
- Status last verified
- Aug 2007
- First submitted
- 9 Aug 2007
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kerry SM, Markus HS, Khong TK, Cloud GC, Tulloch J, Coster D, Ibison J, Oakeshott P. Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial. CMAJ. 2013 Jan 8;185(1):23-31. doi: 10.1503/cmaj.120832. Epub 2012 Nov 5.
PubMed 23128283Kerry S, Markus H, Khong T, Doshi R, Conroy R, Oakeshott P. Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital. Trials. 2008 Mar 19;9:15. doi: 10.1186/1745-6215-9-15.
PubMed 18353175
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital
- ClinicalTrials.gov ID
- NCT00514800
- Acronym / sponsor ID
- 07.0002
- Conditions
- Stroke, Ischemic Attack, Transient
- Keywords
- Home monitoring, Primary care, Hypertension, TIA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- The Stroke Association, United Kingdom
- Study start
- Mar 2007
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Aug 2007 (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.
Design: Community based randomised trial with follow up after 12 months Participants: 360 patients admitted with stroke or TIA within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. All patients will be visited by the specialist nurse at home at baseline when she will measure their BP and administer a questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another researcher blind as to whether the patient is in intervention or control group.
Intervention: Intervention patients will be given a validated home BP monitor and support from the specialist nurse. Control patients will continue with usual care (BP monitoring by their practice).
Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost effectiveness: Incremental cost of the intervention to the NHS and incremental cost per quality adjusted life year gained.
Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood pressure after 12 months compared with usual GP care
Detailed description
High blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate. Home blood pressure monitoring may increase patients' involvement in their care, increase compliance, and reduce the need for patients to attend their GP if blood pressure is adequately controlled. However the value of home monitoring to improve BP control is unclear and there is now a window of opportunity for evaluation before their use becomes widespread in the UK. Furthermore its use in stroke patients presents unique challenges relating to the consequent neurological disability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention - a validated home BP monitor and support from the specialist nursePatients will be given a home blood pressure monitor and taught how to use it and how to respond to the readings using a standardised protocol and blood pressure targets. The study nurse will follow up patients at home after a month with additional telephone support according to a defined protocol. Patients will consult their own GP for medication changes when above target. GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings. |
| Control | Active comparator | Behavioral: Control - usual care (BP monitoring by their practice) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke or TIA in last 9 months
- Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication
Key exclusion criteria (5 listed)
- Severe illness likely to dominate pattern of care
- Already using home blood pressure monitor
- Non-English speaking
- Severe cognitive impairment (AMTS<7)
- Known secondary hypertension
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 |
|---|---|---|
| Intervention - a validated home BP monitor and support from the specialist nurse | Behavioural | Intervention |
| Control - usual care (BP monitoring by their practice)Patients will not receive a blood pressure monitor and will continue with usual GP care for hypertension management. GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings. | Behavioural | Control |
Primary outcome
Reduction in systolic blood pressure taken by study team at home visit
Time frame: 12 months
6 secondary outcomes
Reduction in diastolic blood pressure taken by study team at home visit
Time frame: 12 months
Reduction in SBP and DBP taken by study team at home visit
Time frame: 6 months
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
Time frame: 12 months
EQ-5D
Time frame: 12 months
FEAR
Time frame: 12 months
Incremental cost of the intervention to the NHS and cost per QALY
Time frame: 12 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 9 Jun 2015.
- Derived from this study: PubMed 23128283Kerry SM, Markus HS, Khong TK, Cloud GC, Tulloch J, Coster D, Ibison J, Oakeshott P. Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial. CMAJ. 2013 Jan 8;185(1):23-31. doi: 10.1503/cmaj.120832. Epub 2012 Nov 5.
- Derived from this study: PubMed 18353175Kerry S, Markus H, Khong T, Doshi R, Conroy R, Oakeshott P. Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital. Trials. 2008 Mar 19;9:15. doi: 10.1186/1745-6215-9-15.
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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.
Sally Kerry, MSc principal investigator
St George's, University of London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intervention - a validated home BP monitor and support from the specialist nurse in people with Stroke and Ischemic Attack, Transient, run by St George's, University of London at 3 sites 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 2 inclusion and 5 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 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Reduction in systolic blood pressure taken by study team at home visit (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514800, which also lists 2 linked publications.
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 9 Jun 2015.