ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000083493

Ethics application status

Approved

Date submitted

7/11/2006

Date registered

24/01/2007

Date last updated

25/10/2007

Type of registration

Prospectively registered

Titles & IDs

Public title

A Cluster Randomised controlled trial of an Automated versus manual device for Blood pressure management.

Scientific title

A cluster randomised controlled trial of the effect of general practitioner blood pressure measurement of all patients aged 18 years or over who present during the study week, using automated or manual blood pressure device on digit preference, number of measurements (overall and per individual), prescribing of antihypertensive medications, dose adjustments, and mean systolic and diastolic blood pressure.

Universal Trial Number (UTN)

Trial acronym

CRAB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Blood pressure measurement

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

GP participants in practices randomised to receive automated blood pressure measuring device, the OMRON HEM-907 in all clinical rooms.
The duration of the intervention will be one week after an initial 1 week run-in phase.
Blood pressure recordings of all patients aged 18 years or more and hypertension management (where relevant) is determined by research nurses auditing clinical records once after the trial week.
Both the number and level of blood pressure is determined by searching electronic and paper clinical records of the patient for the study week and recording each on an audit sheet.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

GP participants in practices randomised to control will use usual practice.

Control group

Active

Outcomes

Primary outcome [1]

Digital preference in blood pressure recordings (1mmHg tolerance in automated devices, 2mmHg in manual).

Timepoint [1]

Audit of clinical record once after the study week.

Secondary outcome [1]

BP recordings made overall and per individual

Timepoint [1]

Audit of clinical record once after the study week.

Secondary outcome [2]

prescriptions of antihypertensive medications

Timepoint [2]

Audit of clinical record once after the study week.

Secondary outcome [3]

dose adjustments of antihypertensive medications

Timepoint [3]

Audit of clinical record once after the study week.

Secondary outcome [4]

Mean of systolic blood pressure recordings

Timepoint [4]

Audit of clinical record once after the study week.

Secondary outcome [5]

Mean of diastolic blood pressure recordings

Timepoint [5]

Audit of clinical record once after the study week.

Eligibility

Key inclusion criteria

Inclusion criteria: General practices where at least one registered and practicing general practitioner has signed informed consent.

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Exclusion criteria. General practices where automated blood pressure devices are currently used.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central cluster randomisation of general practices.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomization table created by a computer software

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

24

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

High Blood Pressure Research Council of Australia

Address [1]

Secretariat
4/184 Main Street
LILYDALE VIC 3140

Country [1]

Australia

Primary sponsor type

Other

Name

Menzies Research Institute

Address

Private Bag 33
Hobart TAS 7001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Health and Medical Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/10/2006

Ethics approval number [1]

H9092

Summary

Brief summary

Hypertension is the commonest problem managed in general practice. In this setting as in others control remains less than ideal. As there is a linear relationship between blood pressure level and risk of death any change in standard management that leads to improved blood pressure control is likely to be beneficial.
CRAB will compare the measurement and management of sequential adults attending a general practice over a week.  It will use the endpoints of digital preference, the number of individuals who have a blood pressure measurement, the number of measurements an individual has, mean systolic and diastolic blood pressure, and drug management where hypertension is treated. It is a trial of clinical effectiveness in general practice where the majority of hypertension is managed.
This study will provide evidence for the potential changes in blood pressure recording and hypertension management of the introduction of new devices not containing mercury which are inevitable due to occupational health and safety concerns of this toxic material.  The OMRON HEM-907 device is a validated blood pressure measurement device.  We hypothesize that the use of automated measurement devices will increase the number of people who have a blood pressure measurement, the number of recordings per individual and will improve the management of individuals with hypertension.

Trial website

Trial related presentations / publications

Nelson MR, Winzenberg T.  A cluster randomised controlled trial of an automated versus manual device for blood pressure management (CRAB).  Hypertension (Volume 49, Number 6, June 2007).

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Mark Nelson

Address

Menzies Research Institute
Private Bag 33
43 Collins St
Hobart TAS 7001

Country

Australia

Phone

+61 3 62264734

Fax

+61 3 62264770

Email

Mark.Nelson@utas.edu.au

Contact person for scientific queries

Name

Mark Nelson

Address

Menzies Research Institute
Private Bag 33
43 Collins St
Hobart TAS 7001

Country

Australia

Phone

+61 3 62264734

Fax

+61 3 62264770

Email

Mark.Nelson@utas.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.