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Effectiveness of Self-monitoring and Treatment of Blood Pressure Following Stroke or Transient Ischaemic Attack (TEST-BP)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Self BP measurement
Standard Care
Standard BP management
Treatment
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Blood pressure monitoring, self BP monitoring, self BP management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of East Anglia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Placebo Comparator

Active Comparator

Arm Label

Standard BP management

Self BP measurement and standard care

Self BP measurement and treatment

Arm Description

Participants will continue to receive routine measurement of BP and management of treatment from their General Practitioner (GP).

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.

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.

Outcomes

Primary Outcome Measures

Change in mean daytime/24 hour BP between baseline and follow-up using 24 hour BP recording and numbers reaching target BP

Secondary Outcome Measures

Full Information

First Posted
May 21, 2015
Last Updated
October 25, 2016
Sponsor
University of East Anglia
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1. Study Identification

Unique Protocol Identification Number
NCT02947490
Brief Title
Effectiveness of Self-monitoring and Treatment of Blood Pressure Following Stroke or Transient Ischaemic Attack
Acronym
TEST-BP
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Blood pressure monitoring, self BP monitoring, self BP management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard BP management
Arm Type
Sham Comparator
Arm Description
Participants will continue to receive routine measurement of BP and management of treatment from their General Practitioner (GP).
Arm Title
Self BP measurement and standard care
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Self BP measurement and treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Self BP measurement
Intervention Description
BP home measurement by patient, results to GP and GP alters treatment as per usual practice
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements
Intervention Type
Other
Intervention Name(s)
Standard BP management
Intervention Description
GP to measure BP and manage BP control
Intervention Type
Other
Intervention Name(s)
Treatment
Intervention Description
Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Potter, DM FRCP
Organizational Affiliation
University of East Anglia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of East Anglia
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7TJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness of Self-monitoring and Treatment of Blood Pressure Following Stroke or Transient Ischaemic Attack

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