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Trial registered on ANZCTR


Registration number
ACTRN12608000281392
Ethics application status
Approved
Date submitted
29/05/2008
Date registered
2/06/2008
Date last updated
27/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled study of a
pre-operative intervention in patients
with diabetes undergoing Cardiac Surgery
Scientific title
A randomised controlled study of a
pre-operative intervention in patients
with diabetes undergoing Cardiac Surgery examining HbA1c levels and mastery of diabetes (usual care v. intervention).
Secondary ID [1] 280658 0
Project 52/08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 3212 0
Cardiovascular disease 3213 0
Condition category
Condition code
Cardiovascular 3377 3377 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative intervention involving review of diabetes treatment, medication and diet. Each person will be assessed by the consultant endocrinologist and their management tailored accordingly by the diabetes nurse consultant and dietician. The pre-operative intervention will occur from their visit to the pre-admission clinic to the time of their six week post-operative visit to out-patients (a total of 12 weeks approximately).
Intervention code [1] 2954 0
Behaviour
Comparator / control treatment
Usual care: this usually means that diabetic patients are only seen following referral after their cardiac operation as required.
Control group
Active

Outcomes
Primary outcome [1] 4267 0
HbA1c- this is assessed every 12 weeks by a venous sample blood test (glycosylated haemoglobin). A pre-operative test 6 weeks before cardiac surgery and a repeat 6 weeks after surgery will allow a comparison of HbA1c levels to be made.
Timepoint [1] 4267 0
6 weeks post operatively. The follow-up is one visit at six-weeks after cardiac surgery.
Secondary outcome [1] 7202 0
Mastery of diabetes using the Diabetes Empowerment Scale-Short Form questionnaire (DES-SF)
Timepoint [1] 7202 0
6 weeks post operatively. The follow-up is one visit at six-weeks after cardiac surgery
Secondary outcome [2] 7203 0
Problem Areas in Diabetes questionnaire
Timepoint [2] 7203 0
6 weeks post operatively. The follow-up is one visit at six-weeks after cardiac surgery

Eligibility
Key inclusion criteria
diagnosed type 2 diabetes mellitus
-HbA1c between 6.5% and 10%*
-age 18 years to 79 years
- the capacity to give and accept informed consent to participate in the research
-attendance at pre-admission clinic
- scheduled cardiac surgery (coronary artery bypass surgery +/- valve surgery)
Minimum age
18 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age under 18 years or >80 years
-chronic renal disease, stage III or IV
-psychosis or psychiatric disorder
-active cancer within last 5 years
-pregnancy (BHCG in urine screening test) or lactation
-inability to provide informed consent (i.e. has an intellectual disability, dementia)
-unable to communicate in English
- additional types of cardiac surgery other than coronary artery bypass surgery +/- valve surgery)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A blinded, randomisation protocol (using SPSS 14.0) via Preventative Cardiology at the Baker Heart Research Institute, will allocate eligible patients to the study intervention or usual care (on a 1:1 basis) after successful screening (HbA1c results required to ensure the level is not above 10%) and enrolment into the study. Randomisation will only occur after informed consent has been obtained from eligible patients and via a blinded protocol using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomisation is based on HbA1c levels and those with a level above 10% will not be randomised but automatically seen by the Diabetes team (due to the unacceptably high HbA1c levles).
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3440 0
Self funded/Unfunded
Name [1] 3440 0
Address [1] 3440 0
Country [1] 3440 0
Primary sponsor type
Hospital
Name
Dept. of Endocrinology and Diabetes
Address
Alfred Hospital,
prahran, Melbourne 3004
Country
Australia
Secondary sponsor category [1] 3082 0
Charities/Societies/Foundations
Name [1] 3082 0
Baker Heart Research Institute
Address [1] 3082 0
75 Commercial Road, Prahran, Melbourne 3004
Country [1] 3082 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5464 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 5464 0
East Block, Alfred Hospital, Melbourne 3004
Ethics committee country [1] 5464 0
Australia
Date submitted for ethics approval [1] 5464 0
Approval date [1] 5464 0
30/05/2008
Ethics approval number [1] 5464 0

Summary
Brief summary
The aim of this study is to evaluate whether a pre-operative clinical medical and educational intervention will improve outcomes after cardiac surgery (such as reduced wound infections through improved glycaemic control). This will be done by providing a rapid clinical assessment and management of patients with diabetes prior to their cardiac surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28632 0
Address 28632 0
Country 28632 0
Phone 28632 0
Fax 28632 0
Email 28632 0
Contact person for public queries
Name 11789 0
Geraldine Lee
Address 11789 0
Preventative Cardiology, Baker Heart Research Institute, Melbourne, 3004.
Country 11789 0
Australia
Phone 11789 0
+613 8532 1637
Fax 11789 0
+613 8532 1100
Email 11789 0
geraldine.lee@baker.edu.au
Contact person for scientific queries
Name 2717 0
Geraldine Lee
Address 2717 0
Preventative Cardiology, Baker Heart Research Institute, Melbourne, 3004.
Country 2717 0
Australia
Phone 2717 0
+613 8532 1637
Fax 2717 0
+613 8532 1100
Email 2717 0
geraldine.lee@baker.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary