Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001276842
Ethics application status
Approved
Date submitted
5/12/2012
Date registered
10/12/2012
Date last updated
11/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does glycosylated haemoglobin (HbA1c) feedback from a Chronic Disease Management Register to treating General Practitioners have an impact on the management of diabetes and increase the proportion of patients with poorly controlled diabetes who achieve good control?
Scientific title
In diabetics with recent glycosylated haemoglobin (HbA1c) > 7 who are on a chronic disease patient register, does a reminder to their GPs about their HbA1c level, compared to usual care, impact upon the management of their diabetes and lead to an improvement in HbA1c levels?
Secondary ID [1] 281625 0
Nil
Universal Trial Number (UTN)
U1111-1137-6149
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 287910 0
Condition category
Condition code
Metabolic and Endocrine 288287 288287 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Letter from register to patient's GP reminding them of the patient's elevated HbA1c level.

This letter will be sent to all GPs of patients in the intervention group once, at the same point in time. This point in time will be at the beginning of the study when all patients have been enrolled in the study.
Intervention code [1] 286158 0
Other interventions
Comparator / control treatment
Usual care.

The patients in the control group will have no further contact with the study investigators except that the study investigators will follow up these patients' HbA1c results for 6 months after the commencement of the study. They will continue to be managed by their usual care givers, eg, GPs, diabetic educators, endocrinologists.
Control group
Active

Outcomes
Primary outcome [1] 288462 0
Change in GP management of patients (i.e. by altering thinking, ordering a retest, changing advice or changing medication).

This will be assessed by examination of the qualitative information collected at the GP Practice Visits.

The interviews will be semi-structured with the following questions used as a guide for the collection of information:
1. Did you receive the intervention letter?
2. What are your views on the letter? Was it valuable to you and/ or your staff (eg Practice Nurse)?
3. Did it lead to any change in the way you or your Practice Nurse managed your patient's diabetes? For example:
Did it change your thinking regarding the management of your patient’s diabetes?
Did it lead to a patient review?
Did it lead to a referral to another health professional?
Did it lead to care plan being developed for the patient? (eg Diabetes Annual Cycle of Care Plan or GP Management Plan)
Did it lead you to do further investigations?
Did it lead you to give different advice to the patient (eg regarding diet or exercise)?
Did it lead to a change in the medications or dose of medications?
4. If the intervention did not lead to any change in the way you managed your patient’s diabetes can you please explain why?
5. Do you have any further comments or feedback about the intervention letter?

Timepoint [1] 288462 0
3 months
Secondary outcome [1] 300218 0
Change in HbA1c levels.

Changes in HbA1c levels will be analysed in two ways:
1) The proportion of patients in the intervention group whose HbA1c level is less than or equal to 7 at 6 months will be compared to the proportion of patients in the control group whose HbA1c level is less than or equal to 7 at 6 months. We expect the intervention group to have a higher proportion than the control group. The statistical significance of the difference in proportions will be assessed to explore whether any difference may be due to chance.
2) The mean reduction in HbA1c levels will be compared in the intervention group and the control group at 6 months. We expect that the intervention group will have a greater average reduction in HbA1c levels than the control group. The statistical significance of the differences in the means will be assessed to explore whether any difference may be due to chance.
Timepoint [1] 300218 0
3 and 6 months

Eligibility
Key inclusion criteria
Adults patients on the Chronic Disease Management Register who have a recent Hba1c level >7.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women.
People unable to provide consent themselves.

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)
All adult patients meeting inclusion criteria (ie. a HbA1c level > 7) will be contacted by mail and invited to participate in the study. Patients will receive comprehensive information regarding the study including an information sheet about the study and a consent form which will also comprise a basic questionnaire about variables that may need to be considered regarding their disease history. Those that don't send in the consent forms will be phoned to ask whether they would like to participate in the study. Consent for these patients will be obtained over the phone with the investigator completing the form. Patients will be randomised in a 1:1 ratio to the control or intervention arm of the study after consent is obtained by a computer generated random allocation algorithm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
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
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2012
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)
ACT,NSW

Funding & Sponsors
Funding source category [1] 286433 0
Self funded/Unfunded
Name [1] 286433 0
Nil, funded through existing section budget
Country [1] 286433 0
Australia
Primary sponsor type
Government body
Name
Health Directorate
Address
GPO Box 825,
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 285218 0
None
Name [1] 285218 0
Address [1] 285218 0
Country [1] 285218 0
Other collaborator category [1] 277210 0
University
Name [1] 277210 0
Australian National University
Address [1] 277210 0
Canberra ACT 0200
Country [1] 277210 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288511 0
ACT Health Directorate Human Research Ethics Committee Low Risk Sub-Committtee
Ethics committee address [1] 288511 0
Ethics committee country [1] 288511 0
Australia
Date submitted for ethics approval [1] 288511 0
Approval date [1] 288511 0
30/11/2012
Ethics approval number [1] 288511 0
ETHLR.12.278

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

Contacts
Principal investigator
Name 35014 0
A/Prof Paul Dugdale
Address 35014 0
Chronic Disease Management
ACT Health Directorate
GPO Box 825
Canberra ACT 2601
Country 35014 0
Australia
Phone 35014 0
+612 62076833
Fax 35014 0
Email 35014 0
[email protected]
Contact person for public queries
Name 18261 0
Paul Dugdale
Address 18261 0
Chronic Disease Management
ACT Health Directorate
GPO Box 825
Canberra ACT 2601
Country 18261 0
Australia
Phone 18261 0
+612 62076833
Fax 18261 0
Email 18261 0
[email protected]
Contact person for scientific queries
Name 9189 0
Clare King
Address 9189 0
Chronic Disease Management
ACT Health Directorate
GPO Box 825
Canberra ACT 2601
Country 9189 0
Australia
Phone 9189 0
+612 62076833
Fax 9189 0
Email 9189 0
[email protected]

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.