Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000166370
Ethics application status
Approved
Date submitted
31/03/2008
Date registered
4/04/2008
Date last updated
4/08/2020
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Shared Team Approach between Nurses and Doctors For Improved Risk Factor Management for stroke patients
Scientific title
A prospective, multicentre, randomised controlled trial of efficacy (control of risk factors at 12 months) and cost effectiveness of a team approach between nurses and doctors (coordinated transition from hospital to general practice) versus standard care (the ongoing care that a patient would normally receive) in patients discharged home after an acute stroke.
Secondary ID [1] 251706 0
Nil Known.
Secondary ID [2] 280422 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
STAND-FIRM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 2983 0
Condition category
Condition code
Public Health 3130 3130 0 0
Health promotion/education
Cardiovascular 3131 3131 0 0
Hypertension
Public Health 3132 3132 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have had a new stroke are randomised to receive a coordinated team approach of risk factor management following discharge home from hospital. The approach involves assessing patients’ risk factors, educating patients about their risk factors, and then treating their risk factors and/or otherwise managing their risk factors with behavioural changes. Both nurses and doctors in hospital and primary care settings coordinate this care. The intervention will continue for 18 months.
Intervention code [1] 2722 0
Prevention
Comparator / control treatment
Standard primary care (the standard care provided in general practice)
Control group
Active

Outcomes
Primary outcome [1] 4015 0
Change in the updated Framingham cardiovascular disease (CVD) Risk Score from baseline. This will be assessed using an updated risk score as outlined by the Framingham investigators (D'Agostino RB, Sr., et al. (2008). General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 117:743-53). The factors included in this measure that are subject to change are: systolic blood pressure; total and high density lipoprotein (HDL) cholesterol levels; diabetes control as measured by glycosylated haemoglobin levels < 7%; and current smoking as assessed by urinary cotinine.
Timepoint [1] 4015 0
One year after randomisation
Secondary outcome [1] 6753 0
Use of antihypertensive therapy. This will be assessed by viewing patient medications.
Timepoint [1] 6753 0
One and 2 years after randomisation
Secondary outcome [2] 6754 0
Use of antiplatelet therapy in ischaemic stroke patients. This will be assessed by viewing patient medications.
Timepoint [2] 6754 0
One and 2 years after randomisation
Secondary outcome [3] 6755 0
Use of cholesterol lowering therapy in ischaemic stroke patients. This will be assessed by viewing patient medications.
Timepoint [3] 6755 0
One and 2 years after randomisation
Secondary outcome [4] 6756 0
Retinal vascular changes. This will be assessed by retinal photography of the eye. These photographs will be graded by a trained retinal grader using a standardised protocol.
Timepoint [4] 6756 0
One year after randomisation
Secondary outcome [5] 6757 0
Smoking. This will be assessed by self-report and verified by testing for cotinine in the urine.
Timepoint [5] 6757 0
One and 2 years after randomisation
Secondary outcome [6] 6758 0
Alcohol Consumption. This will be assessed by self-report (using a standard questionnaire).
Timepoint [6] 6758 0
One and 2 years after randomisation
Secondary outcome [7] 6759 0
Fruit and vegetable intake. This will be assessed by self-report (using a standard questionnaire).
Timepoint [7] 6759 0
One and 2 years after randomisation
Secondary outcome [8] 6760 0
Salt intake. This will be assessed by 24-hour urine collection.
Timepoint [8] 6760 0
One and 2 years after randomisation
Secondary outcome [9] 6761 0
Physical activity. This will be assessed by self-report (using a standard questionnaire) and pedometer counts of steps per day averaged over 7 days.
Timepoint [9] 6761 0
One and 2 years after randomisation
Secondary outcome [10] 6762 0
Adverse events.
Timepoint [10] 6762 0
During the one year period after randomisation
Secondary outcome [11] 6763 0
Quality of Life assessments
Timepoint [11] 6763 0
1 and 2 years after randomisation
Secondary outcome [12] 6764 0
Cost effectiveness and utility
Timepoint [12] 6764 0
One year after randomisation
Secondary outcome [13] 6765 0
Caregiver Quality of Life
Timepoint [13] 6765 0
1 and 2 years after randomisation
Secondary outcome [14] 264152 0
Change in blood pressure from baseline. Standardised blood pressure will be measured after 15 minutes at rest using an Automatic Digital Blood Pressure Monitor and according to a strict protocol.
Timepoint [14] 264152 0
1 and 2 years after randomisation.
Secondary outcome [15] 264153 0
1. A change in modified Framingham cardiovascular disease (CVD) risk score at 12 months (as measured using the score sheet method). The score sheet method comprises 0, 1, 2, 3, etc scores for each of systolic blood pressure, total and HDL cholesterol levels, diabetes control as measured by a glycosylated heamoglobin level of < 7%, and current smoking as measured by urinary cotinine. In addition, it will include other factors currently incorporated in secondary prevention guidelines (0 = treated, 1 = untreated unless otherwise indicated) for antihypertensive therapy; antiplatelet therapy (in those with ischaemic stroke or transient ischaemic attack (TIA) not prescribed anticoagulants); anticoagulation therapy in ischaemic stroke/TIA patients with one of atrial fibrillation, cardioembolic stroke from valvular heart disease, or recent myocardial infarction, unless a contraindication exists; and use of lipid lowering medications (in patients with ischaemic stroke or TIA).
Timepoint [15] 264153 0
1 and 2 years after randomisation.
Secondary outcome [16] 297261 0
Use of antithrombotic therapy in ischaemic stroke patients. This includes the use of anticoagulants in patient with co-morbid atrial fibrillation, as well as the use of antiplatelet agents. This will be assessed by viewing patient medications and determining the presence or absence of atrial fibrillation.
Timepoint [16] 297261 0
1 and 2 years after randomisation.

Eligibility
Key inclusion criteria
Patient with first or recurrent stroke (haemorrhage or infarct) or transient ischaemic attack, admitted to hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients living more than 50km from the hospital, recruited to another clinical trial, or being discharged to a nursing home.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed using centralised randomisation via a computer. Randomisation occurs once the patient provides consent. The nurse undertaking the education is aware of the allocation. The patient, other staff, and the outcome assessor remain blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be concealed using permuted blocks of various lengths. A secure computer-generated randomisation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
6/05/2008
Actual
16/02/2010
Date of last participant enrolment
Anticipated
Actual
21/11/2013
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
564
Accrual to date
Final
563
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1493 0
The Alfred - Prahran
Recruitment hospital [2] 1494 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 1495 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 1496 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 807 0
3181 and surrounding areas
Recruitment postcode(s) [2] 7335 0
3168 - Clayton
Recruitment postcode(s) [3] 7336 0
3128 - Box Hill
Recruitment postcode(s) [4] 7337 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 3247 0
Charities/Societies/Foundations
Name [1] 3247 0
Baker Heart Research Institute
Country [1] 3247 0
Australia
Funding source category [2] 256926 0
Charities/Societies/Foundations
Name [2] 256926 0
The Ivor Ronald Evans foundation provided us with initial seeding funding enabling us to complete follow-up on our pilot cases.
Country [2] 256926 0
Australia
Funding source category [3] 256927 0
Government body
Name [3] 256927 0
National Health & Medical Research Council
Country [3] 256927 0
Australia
Primary sponsor type
Other
Name
Monash University
Address
Wellington Road
Clayton 3800
Victoria
Country
Australia
Secondary sponsor category [1] 2903 0
None
Name [1] 2903 0
Address [1] 2903 0
Country [1] 2903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5231 0
Alfred Hospital Research & Ethics Committee
Ethics committee address [1] 5231 0
Commercial Road
Prahran 3181
Ethics committee country [1] 5231 0
Australia
Date submitted for ethics approval [1] 5231 0
25/03/2008
Approval date [1] 5231 0
02/05/2008
Ethics approval number [1] 5231 0
91/08
Ethics committee name [2] 5243 0
Eastern Health Research and Ethics
Ethics committee address [2] 5243 0
Nelson Road
Box Hill
Ethics committee country [2] 5243 0
Australia
Date submitted for ethics approval [2] 5243 0
Approval date [2] 5243 0
18/06/2010
Ethics approval number [2] 5243 0
E101/0910
Ethics committee name [3] 5244 0
Southern Health Human Research Ethics Committee
Ethics committee address [3] 5244 0
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria, Australia
Ethics committee country [3] 5244 0
Australia
Date submitted for ethics approval [3] 5244 0
01/04/2008
Approval date [3] 5244 0
16/07/2010
Ethics approval number [3] 5244 0
10102B
Ethics committee name [4] 298828 0
Australian Institute of Health and Welfare
Ethics committee address [4] 298828 0
1 Thynne St
Bruce, ACT 2617
Ethics committee country [4] 298828 0
Australia
Date submitted for ethics approval [4] 298828 0
06/10/2016
Approval date [4] 298828 0
15/11/2016
Ethics approval number [4] 298828 0
EO2016/4/325
Ethics committee name [5] 303555 0
Monash University Human Research Ethics Committee
Ethics committee address [5] 303555 0
Monash University
Wellington Road
Clayton
Ethics committee country [5] 303555 0
Australia
Date submitted for ethics approval [5] 303555 0
18/10/2017
Approval date [5] 303555 0
23/11/2017
Ethics approval number [5] 303555 0
11592

Summary
Brief summary
A randomised-controlled trial of a shared approach to risk management (the intervention) versus standard care (control) following stroke. Outcome is blinded and analysis is intention-to-treat. A cost-effectiveness analysis is included. It is hypothesised that at 12 months following stroke a shared nurse/doctor team approach to risk factor management will result in improved management of patients risk factors, result in fewer adverse events, and will be cost-effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28480 0
Prof Amanda Thrift
Address 28480 0
Stroke and Ageing Research Centre (STARC), Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 3/27-31 Wright Street, Clayton VIC 3168
Country 28480 0
Australia
Phone 28480 0
+61 3 8572-2656
Fax 28480 0
Email 28480 0
amanda . thrift @ monash . edu
Contact person for public queries
Name 11637 0
Prof Professor Amanda Thrift
Address 11637 0
Stroke and Ageing Research Centre (STARC), Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 3/27-31 Wright Street, Clayton VIC 3168
Country 11637 0
Australia
Phone 11637 0
+61 3 8572-2656
Fax 11637 0
+61 3 9902-4240
Email 11637 0
amanda . thrift @ monash . edu
Contact person for scientific queries
Name 2565 0
Prof Professor Amanda Thrift
Address 2565 0
Epidemiology & Prevention Unit, Stroke and Ageing Research Centre (STARC),
Department of Medicine, Monash Medical Centre,
Southern Clinical School, Monash University,
Level 1/43-51 Kanooka Grove, Clayton VIC 3168
Country 2565 0
Australia
Phone 2565 0
+61 3 8572-2656
Fax 2565 0
+61 3 9902-4240
Email 2565 0
amanda . thrift @ monash . edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8691Study protocolThrift AG, Srikanth VK, Nelson MR, Kim J, Fitzgerald SM, Gerraty R, Bladin CF, Phan TG, Cadilhac DA (2014). Risk factor management in survivors of stroke: a double-blind, cluster randomised-controlled trial. International Journal of Stroke 9(5):652-657https://journals.sagepub.com/doi/10.1111/j.1747-4949.2012.00933.x 
8692Statistical analysis planThrift AG, Olaiya MT, Phan TG, Cadilhac DA, Nelson MR, Srikanth VK on behalf of the STANDFIRM Investigators (2015). Statistical analysis plan (SAP) for STANDFIRM: Shared Team Approach Between Nurses and Doctors For Improved Risk Factor Management: A Randomised Controlled Trial. International Journal of Stroke 10(7):770-772.https://journals.sagepub.com/doi/10.1111/ijs.12482 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Thrift AG, Srikanth VK, Nelson MR, Kim J, Fitzgera... [More Details]
Study results articleYes Thrift AG, Olaiya MT, Phan TG, Cadilhac DA, Nelson... [More Details]
Study results articleYes Olaiya MT*, Kim J*, Nelson MR, Srikanth VK, Bladin... [More Details]
Study results articleYes Olaiya MT, Cadilhac DA, Kim J, Ung D, Nelson MR, S... [More Details]
Study results articleYes Olaiya MT, Cadilhac DA, Kim J, Nelson MR, Srikanth... [More Details]
Study results articleYes Olaiya MT, Cadilhac DA, Kim J, Ung D, Nelson MR, S... [More Details]
Study results articleYes Olaiya MT, Cadilhac DA, Kim J, Nelson MR, Srikanth... [More Details]
Other filesNo STAND FIRM (Shared Team Approach between Nurses an... [More Details]
Other filesNo Olaiya MT*, Kim J*, Nelson MR, Srikanth VK, Bladin... [More Details]
Other filesNo Olaiya MT*, Kim J*, Nelson MR, Srikanth VK, Bladin... [More Details]
Other filesNo Olaiya MT, Kim J, Nelson MR, Srikanth VK, Bladin C... [More Details]
Other filesNo Olaiya MT, Kim J, Cadilhac DA, Srikanth VK, Thrift... [More Details]
Other filesNo Olaiya MT, Cadilhac DA, Kim J, Nelson MR, Srikanth... [More Details]
Other filesNo Olaiya MT, Cadilhac DA, Kim J, Ung D, Nelson MR, S... [More Details]
Other filesNo Olaiya MT, Cadilhac DA, Kim J, Nelson MR, Srikanth... [More Details]
Other filesNo Olaiya MT, Cadilhac DA, Kim J, Nelson MR, Srikanth... [More Details]
Other filesNo Ung D, Gerraty RP, Frayne J, Olaiya MT, Kim J, Sri... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term unmet needs and associated factors in stroke or TIA survivors.2017https://dx.doi.org/10.1212/WNL.0000000000004063
EmbaseEffectiveness of an Intervention to Improve Risk Factor Knowledge in Patients with Stroke: A Randomized Controlled Trial.2017https://dx.doi.org/10.1161/STROKEAHA.116.016229
EmbaseCommunity-Based Intervention to Improve Cardiometabolic Targets in Patients with Stroke: A Randomized Controlled Trial.2017https://dx.doi.org/10.1161/STROKEAHA.117.017499
EmbaseQuality of life after stroke: a longitudinal analysis of a cluster randomized trial.2022https://dx.doi.org/10.1007/s11136-021-03066-y
N.B. These documents automatically identified may not have been verified by the study sponsor.