Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000594426
Ethics application status
Approved
Date submitted
12/11/2007
Date registered
19/11/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Using conversational computer technology to improve diabetes management: a randomised controlled trial.
Scientific title
A randomised controlled trial to determine the impact of using conversational computer technology on clinical, self-management and behavioural outcomes in patients with type 2 diabetes.
Secondary ID [1] 252669 0
Nil
Universal Trial Number (UTN)
Trial acronym
TLC Diabetes.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes. 2540 0
Condition category
Condition code
Metabolic and Endocrine 2640 2640 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects receiving the Telephone Linked Care (TLC) intervention will continue to receive their usual medical care. In addtion they will receive the TLC intervention consisting of a computer equipped with sophisticated speech recognition and voice processing software, a database and a control system. Users call into the system from their regular telephone or mobile phone. TLC interviews and converses with the user via pre-recorded statements and questions. It “listens” to answers and records them in the database and uses them to provide feedback and tailor current and future conversations. Prior to each call, users will also upload their most recent glucose meter results via a data transmitter connected to a dedicated mobile phone. The delivery of the TLC Program will be complemented by a Case Manager. Participants will call the TLC System on the same day, weekly, for 6 months.
Intervention code [1] 2272 0
Other interventions
Comparator / control treatment
Usual care from GP and/or endocrinologist.
Control group
Active

Outcomes
Primary outcome [1] 3549 0
Quality of life as measured by questionnaire.
Timepoint [1] 3549 0
6 and 12 months.
Primary outcome [2] 3550 0
HbA1c as measured by venous blood sampling.
Timepoint [2] 3550 0
6 and 12 months.
Secondary outcome [1] 5939 0
Other clinical outcomes (insulin sensitivity, blood pressure, Body Mass Index, lipid profile). These will be measured by venous blood sampling and anthropometric measurement.
Timepoint [1] 5939 0
6 and 12 months.

Eligibility
Key inclusion criteria
1. Diagnosis of type 2 diabetes. 2. Stable diabetes therapy for previous 3 months. 3. Ability to converse in and understand English via the telephone. 4. Having access to a telephone. 5. Haemoglobin A1C (HbA1c), pathology test, equal to or greater than 7.5. 6. Live within the greater Brisbane area
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Enrollment in another significiant research study. 2. Presence of dementia or other cognitive impairment. 3. Pregnancy.

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)
Subjects will be recruited using multiple methods including newspaper adverts, hospital outpatient departments and Diabetes Australia Queensland newsletters. Allocation concealment is by way of opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer generated random number sampling.
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
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2783 0
Government body
Name [1] 2783 0
NHMRC
Country [1] 2783 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Epidemiology and Preventive Medicine
Monash University
Alfred Hospital Campus
Level 3 (Burnet Tower)
89 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 2515 0
Hospital
Name [1] 2515 0
Princess Alexandra Hospital
Address [1] 2515 0
University of Queensland Centre for Diabetes and Endocrine Research
Ipswich Road
Woolloongabba QLD 4102
Country [1] 2515 0
Australia
Other collaborator category [1] 85 0
University
Name [1] 85 0
Centre for Online Health
Address [1] 85 0
Royal Childrens Hospital
Herston QLD 4029
Country [1] 85 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4702 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 4702 0
Monash University
Building 3E
Wellington Road
Clayton VIC 3800
Ethics committee country [1] 4702 0
Australia
Date submitted for ethics approval [1] 4702 0
Approval date [1] 4702 0
14/03/2007
Ethics approval number [1] 4702 0
CF07/0313 - 2007/0102
Ethics committee name [2] 5178 0
Princess Alexandra Human Research Ethics Committee
Ethics committee address [2] 5178 0
Ipswich Road
Woolloongabba Qld 4102
Ethics committee country [2] 5178 0
Australia
Date submitted for ethics approval [2] 5178 0
Approval date [2] 5178 0
13/09/2007
Ethics approval number [2] 5178 0
2007/029

Summary
Brief summary
The aim of this study is to evaluate the impact of a computer-controlled, automated and interactive telephone system on the self management of people with type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28175 0
Address 28175 0
Country 28175 0
Phone 28175 0
Fax 28175 0
Email 28175 0
Contact person for public queries
Name 11332 0
Professor Brian Oldenburg
Address 11332 0
Department of Epidemiology and Preventive Medicine
Monash University
Alfred Hospital Campus
Level 3 (Burnet Tower)
89 Commercial Road
Melbourne VIC 3004
Country 11332 0
Australia
Phone 11332 0
+61 3 99030046
Fax 11332 0
Email 11332 0
[email protected]
Contact person for scientific queries
Name 2260 0
Professor Brian Oldenburg
Address 2260 0
Department of Epidemiology and Preventive Medicine
Monash University
Alfred Hospital Campus
Level 3 (Burnet Tower)
89 Commercial Road
Melbourne VIC 3004
Country 2260 0
Australia
Phone 2260 0
+61 3 99030046
Fax 2260 0
Email 2260 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.