- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02947490
Effectiveness of Self-monitoring and Treatment of Blood Pressure Following Stroke or Transient Ischaemic Attack (TEST-BP)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Norfolk
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Norwich, Norfolk, United Kingdom, NR4 7TJ
- University of East Anglia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Standard BP management
Participants will continue to receive routine measurement of BP and management of treatment from their General Practitioner (GP).
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GP to measure BP and manage BP control
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Placebo Comparator: Self BP measurement and standard care
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.
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BP home measurement by patient, results to GP and GP alters treatment as per usual practice
Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements
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Active Comparator: Self BP measurement and treatment
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.
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Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements
Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Potter, DM FRCP, University of East Anglia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JPotter
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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