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Trial registered on ANZCTR


Registration number
ACTRN12609000075280
Ethics application status
Approved
Date submitted
24/11/2008
Date registered
30/01/2009
Date last updated
30/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the Health Management Coaching model effective at improving risk factor status and increasing adherence to monitoring requirements in people with diabetes?
Scientific title
Is the Health Management Coaching model effective at improving risk factor status and increasing adherence to monitoring requirements in people with diabetes?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 and Type 2 Diabetes 4008 0
Condition category
Condition code
Metabolic and Endocrine 4211 4211 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention for this study is telephone coaching. Involves and Health Management Coach / Dietitian conducting telephone coaching sessions with patients every 4-6 weeks for a period of 6 months. Each telephone call will take 20 to 45 minutes. Telephone coaching will occur in addition to the patient's usual care. During coaching sessions, participants will be coached to understand : 1) what risk factor needs to be monitored - for example HbA1C should be checked 2) When each risk factor needs to be checked – in the case of HbA1C, every 3 months 3) And for risk factors not at target level – how to modify these through changes to diet, lifestyle and in consultation with their General Practitioner (GP), medications.
Intervention code [1] 3734 0
Other interventions
Comparator / control treatment
Active Control - standard treatment (usual diabetes care under existing healthcare team) Usual care will vary for each patient depending on their individual needs, but generally refers to the healthcare arrangements existing when the patient enters the research project and those which may evolve at the discretion of the patient and their healthcare team during the patients time in the study. Health professionals who may contribute to their usual care include GP, endocrinologist, dietitian, psychologist, podiatrist, diabetes educator, exercise preofession, optomotrist / opthalmologist. Patients will continue their usual care for the duration of the trial (i.e. 18 months)
Control group
Active

Outcomes
Primary outcome [1] 5105 0
HbA1C will be measured by blood sample. Researchers will provide patients with a pathology slip that for HBA1C, fasting lipids, fasting glucose and urinary albumin excretion. Blood and urine samples will be taken at a St Vincent's Pathology collection centre and the below outlined timepoints.
Timepoint [1] 5105 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [1] 8582 0
Fasting blood glucose will be measured by blood sample. Researchers will provide patients with a pathology slip that for HBA1C, fasting lipids, fasting glucose and urinary albumin excretion. Blood and urine samples will be taken at a St Vincent's Pathology collection centre and the below outlined timepoints.
Timepoint [1] 8582 0
baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [2] 8583 0
Blood lipid levels will be measured by blood sample. Researchers will provide patients with a pathology slip that for HBA1C, fasting lipids, fasting glucose and urinary albumin excretion. Blood and urine samples will be taken at a St Vincent's Pathology collection centre and the below outlined timepoints.
Timepoint [2] 8583 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [3] 8584 0
Blood Pressure - Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will measure the participant's blood pressure using a sphygmometer.
Timepoint [3] 8584 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [4] 8585 0
Body Mass Index - Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will measure the patient height and weight and calculate their BMI during this visit.
Timepoint [4] 8585 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [5] 8586 0
Waist Circumference - Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will measure the participant's waist circumference using a tapemeasure during this visit.
Timepoint [5] 8586 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [6] 8587 0
Cigarette consumption - Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the participants and ask their smoking status.
Timepoint [6] 8587 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [7] 8588 0
Alcohol intake - Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report their alcohol intake (eg drinks per week and number of alcohol free days per week.)
Timepoint [7] 8588 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [8] 8589 0
Physical activity level - Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report the number of minutes of moderate intensity physical activity they perform each week.
Timepoint [8] 8589 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [9] 8590 0
Adherence to minimum monitoring requirements for regular checks of blood glucose levels. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report how often they currently measure blood glucose levels.
Timepoint [9] 8590 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [10] 8591 0
Adherence to minimum monitoring requirements for regular checks of HbA1C. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report when they last had their HbA1C measured.
Timepoint [10] 8591 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [11] 8592 0
Adherence to minimum monitoring requirements for regular checks of fasting lipid levels. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report when they last had fasting lipid levels measured.
Timepoint [11] 8592 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [12] 8593 0
Adherence to minimum monitoring requirements for regular checks of fasting blood pressure. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report how often in the past 6 months they have had their blood pressure measured.
Timepoint [12] 8593 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [13] 8594 0
Adherence to minimum monitoring requirements for regular checks of urinary albumin excretion. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report when they last had their urinary albumin excretion measured.
Timepoint [13] 8594 0
baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [14] 8595 0
Adherence to minimum monitoring requirements for regular checks of feet. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report when they last had a food check.
Timepoint [14] 8595 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [15] 8596 0
Adherence to minimum monitoring requirements for regular checks of eyes. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report when they last had their eyes checked.
Timepoint [15] 8596 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [16] 8597 0
Compliance with guidelines recommending regular Electrocardiogram (ECG). Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report when they last had an ECG.
Timepoint [16] 8597 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [17] 8598 0
Compliance with guidelines recommending regular vaccinations for influenza and pneumococcal. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report when they last were vaccinated against influenza and pneumococcal.
Timepoint [17] 8598 0
At baseline and at 6, 12, and 18 months after intervention commencement
Secondary outcome [18] 8599 0
Compliance with guidelines recommending prescription of prophylactic aspirin. Patients will be asked to return to St Vincent's hospital at the below outlined timepoints. A researcher will interview the patient and ask them to report whether they are currently prescribed prophylactic aspirin
Timepoint [18] 8599 0
At baseline and at 6, 12, and 18 months after intervention commencement

Eligibility
Key inclusion criteria
All patients attending Diabetes Clinic, aged 18 years or over with an HbA1C = 7.0% and eligible for Hospital Admission Risk Program(HARP) Services (i.e. defined as people with chronic diseases and complex needs who frequently use hospitals or who are at risk of hospitalisation)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to provide informed consent including those with insufficient English to adequately communicate; patients intoxicated with alcohol, or who are cognitively impaired. Also, those receiving palliative care and patients unable to easily or accurately communicate over the telephone due to severe hearing impairment or lack of telephone access

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)
Over six months, a convenience sample of eligible people aged =18 years attending the Diabetes Clinic will be approached directly by researchers for study participation. Eligible people will be approached in the Outpatient waiting area. The study will be explained to each person; consent to participate will be obtained; the participant will be randomised into either the intervention or control group and the researcher will collect baseline and demographic information from the participant and their medical record. After consenting the participant will be randomised to one of two groups. Allocation concealment will occur by way of the researcher opening a blank envelope containing a computer generated random allocation for the recruited participant into either the intervention or control group. This will occur after the patient has consented to being involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After consenting the participant will be randomised to one of two groups. The researcher will open a blank envelope containing a computer generated random allocation for the recruited participant into either the intervention or control group.
Masking / blinding
Open (masking not 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
Not yet recruiting
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] 4198 0
Hospital
Name [1] 4198 0
St Vincent's Hospital Melbourne
Address [1] 4198 0
PO Box 2900, Fitzroy 3065 VIC
Country [1] 4198 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
PO Box 2900, Fitzroy 3065 VIC
Country
Australia
Secondary sponsor category [1] 3970 0
Government body
Name [1] 3970 0
Department of Human Services
Address [1] 3970 0
Department of Human Services
50 Lonsdale Street
Melbourne, Victoria
Australia 3000
Country [1] 3970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6418 0
Professional Secretariate of Human research Ethics comittee - A (HREC-A)
Ethics committee address [1] 6418 0
HREC-A
C/o Research and Grants Unit
St Vincent's Hospital Melbourne
PO Box 2900, Fitzroy VIC 3065
Ethics committee country [1] 6418 0
Australia
Date submitted for ethics approval [1] 6418 0
Approval date [1] 6418 0
15/12/2008
Ethics approval number [1] 6418 0
134/08

Summary
Brief summary
The proposed study examines the impact of a specific telephone coaching intervention on HbA1C. HbA1C reflects average glucose concentration over ~3months. Secondary outcomes will include fasting glucose, lipids and blood pressure. Adherence to monitoring requirements will also be measured e.g. regular checks of HbA1C, lipids, feet & eyes. The intervention in question is currently in use in the cardiac population where its efficacy has been demonstrated by two Randomised Controlled Trials (RCTs).
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 29155 0
Address 29155 0
Country 29155 0
Phone 29155 0
Fax 29155 0
Email 29155 0
Contact person for public queries
Name 12312 0
Jane Varney
Address 12312 0
PO Box 2900, Fitzroy VIC 3065
Country 12312 0
Australia
Phone 12312 0
+61 3 92882740
Fax 12312 0
+61 3 92882787
Email 12312 0
jane.varney@svhm.org.au
Contact person for scientific queries
Name 3240 0
Jane Varney
Address 3240 0
PO Box 2900, Fitzroy VIC 3065
Country 3240 0
Australia
Phone 3240 0
+61 3 92882740
Fax 3240 0
+61 3 92882787
Email 3240 0
jane.varney@svhm.org.au

No information has been provided regarding IPD availability
Summary results
No Results