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

NCT02947490 | Completed Phase 3 DMC

• 1 other identifier: JPotter
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Blood pressure monitoring; self BP monitoring; self BP management

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (3)

Standard BP management

SHAM COMPARATOR

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

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.

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.

Other: Standard Care; Other: Treatment

Interventions

Self BP measurement OTHER

BP home measurement by patient, results to GP and GP alters treatment as per usual practice

Self BP measurement and standard care

Standard Care OTHER

Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements

Self BP measurement and standard care; Self BP measurement and treatment

Standard BP management OTHER

GP to measure BP and manage BP control

Standard BP management

Treatment OTHER

Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.

Self BP measurement and treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• John Potter, DM FRCP

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: October 28, 2016
• Study Start: September 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

GB (1)