Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000019505
Ethics application status
Approved
Date submitted
11/01/2006
Date registered
13/01/2006
Date last updated
13/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self Management of Anticoagulation Research Trial
Scientific title
A Study to Evaluate the Impact of Patient Self Management on Oral Anticoagulation of Patients with Mechanical Heart Valve Replacement and/or Chronic Atrial Fibrillation
Universal Trial Number (UTN)
Trial acronym
Warfarin 'SMART'
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Anticoagulation 980 0
Condition category
Condition code
Cardiovascular 1055 1055 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible patients are randomly allocated to either on-going Usual Care (International Normalised Ratio (INR) management by their local doctor or hospital clinic) or to Self Management (testing INR at home with an investigational device and dosing algorithm) for a 12-month period.

Patients allocated to the Self Management group receive three 90-minute training sessions in (i) the therapeutic use of warfarin (also attended by the Usual Care group), (ii) practical use of the device (CoaguChek S), and, (iii) implementing the self-dosing algorithm (a colour-coded INR warfarin-dosing algorithm). This algorithm uses small dose adjustments (5-33% of the maintenance dose is used) according to AHA guidelines, to maintain tight control.

Fortnightly Diary - All patients report to the Study Coordinator fortnightly by completing the fortnightly diary for the 12-month study period. This is an easy to complete form with closed and open-ended questions. It gathers information related to any illnesses, complications of warfarin therapy, new medications commenced and surgical procedures performed.

Outcome INR - All patients have an outcome INR tested monthly for 12 months. The Outcome INR’s are carried out at one laboratory in order to eliminate interlab variability. This INR is not used in either group to regulate warfarin dose, it is purely to allow for statistical analysis of equal numbers of variables in both groups.

Testing Frequency - The Usual Care group are managed by their GP who will test the INR and dose the warfarin at least once per month. These results are logged and returned to the study coordinator.
Self Management patients check their INR weekly with the device at home. The frequencies of testing and dose adjustments are specified in the algorithm (Colourchart) that is specific to this trial (i.e. if in therapeutic range the patients tests every 7 days but if their INR varies above or below range it is checked in 2 days and dose adjustments are made accordingly).

Quality of Life - In order to assess the patients quality of life, all patients complete a treatment related, structured questionnaire at baseline, 6 months and on completion of the 12-month study period
Intervention code [1] 836 0
None
Comparator / control treatment
Usual Care
Control group
Active

Outcomes
Primary outcome [1] 1410 0
The proportion of times that the centrally measured monthly Outcome INR is outside of therapeutic range.
Timepoint [1] 1410 0
Measured monthly over a 12 month period
Secondary outcome [1] 2497 0
i) Number of times monthly Outcome INR results in extreme (>4.5, <1.5) range.
Timepoint [1] 2497 0
Secondary outcome [2] 2498 0
ii) Rates of Serious Adverse Events related to bleeding or thrombosis over a 12 month period as defined in protocol.
Timepoint [2] 2498 0

Eligibility
Key inclusion criteria
1. Patient has one or more mechanical valve(s) or chronic (greater than 3 months) Atrial Fibrillation. 2. Patient has been taking Warfarin/Coumadin for at least 3 months. 3. Patients INR has been in therapeutic range for > 2 weeks. 4. Patient has had no more than a <2mg change in their warfarin dose in the last four weeks. 5. Patient speaks English. 6. Patient can read English. 7. Patient has access to a telephone.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient is known to have a coagulation disorder2. Patient has known underlying liver disease3. Patient has a drug or alcohol addiction that is likely to limit compliance with the study routine.4. Patient has a visual deficit likely to limit compliance.5. Patient failed the mini mental test (AMT)6. Patient has any other condition that is likely to limit compliance (e.g. tremor or tactile dysfunction).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer Software and Minimisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1152 0
Hospital
Name [1] 1152 0
Royal Prince Alfred Hospital Cardiothoracic Department
Country [1] 1152 0
Australia
Funding source category [2] 1153 0
Commercial sector/Industry
Name [2] 1153 0
Roche Diagnostics Australia Pty Ltd
Country [2] 1153 0
Australia
Funding source category [3] 1154 0
Commercial sector/Industry
Name [3] 1154 0
Davies Campbell deLambert Pty Ltd
Country [3] 1154 0
Australia
Funding source category [4] 1155 0
Government body
Name [4] 1155 0
NH&MRC CTC
Country [4] 1155 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital Cardiothoracic Department
Address
Country
Australia
Secondary sponsor category [1] 1014 0
University
Name [1] 1014 0
NH&MRC CTC
Address [1] 1014 0
Country [1] 1014 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2475 0
Royal Prince Alfred Hospital
Ethics committee address [1] 2475 0
Ethics committee country [1] 2475 0
Australia
Date submitted for ethics approval [1] 2475 0
Approval date [1] 2475 0
Ethics approval number [1] 2475 0
Ethics committee name [2] 2476 0
Liverpool Hospital
Ethics committee address [2] 2476 0
Ethics committee country [2] 2476 0
Australia
Date submitted for ethics approval [2] 2476 0
Approval date [2] 2476 0
Ethics approval number [2] 2476 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35418 0
Address 35418 0
Country 35418 0
Phone 35418 0
Fax 35418 0
Email 35418 0
Contact person for public queries
Name 10025 0
Catherine Powell
Address 10025 0
Department of Cardiothoracic Surgery
Royal Prince Alfred Hospital
Level 6 West
Building 75
Missenden Road
Camperdown NSW 2050
Country 10025 0
Australia
Phone 10025 0
+61 2 95156366
Fax 10025 0
Email 10025 0
catherine.powell@email.cs.nsw.gov.au
Contact person for scientific queries
Name 953 0
Dr Rebecca Dignan
Address 953 0
Liverpool Hospital
Level 1
Clinical Building
Locked Bag 7103
Liverpool BC NSW 1871
Country 953 0
Australia
Phone 953 0
+61 2 98283006
Fax 953 0
Email 953 0
rebecca.dignan@swsahs.nsw.gov.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
SourceTitleYear of PublicationDOI
EmbaseSelf-monitoring and self-management of oral anticoagulation.2016https://dx.doi.org/10.1002/14651858.CD003839.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.