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Trial registered on ANZCTR


Registration number
ACTRN12613000391774
Ethics application status
Approved
Date submitted
26/03/2013
Date registered
10/04/2013
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
3/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of Integrated Disease Self-Management in Type 2 Diabetes Mellitus
Scientific title
Supported self management versus written information for improving HbA1c, weight and mood in people with long-standing type 2 diabetes
Secondary ID [1] 282167 0
Nil
Universal Trial Number (UTN)
U1111-1140-9397
Trial acronym
INSPIRED: Individual Support and Resources for Diabetes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 288673 0
Condition category
Condition code
Metabolic and Endocrine 289024 289024 0 0
Diabetes
Public Health 289165 289165 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chronic disease self management manual and 7 sessions with a Health Coach over a period of 7 weeks (1 face-to-face, 6 weekly telephone calls). The duration of each session will be approximately 30 minutes and will involve supporting the participant to work through the manual, and by answering questions, and discussing the homework exercises.

The structured manual ensures that a comprehensive care plan is devised and the health professional is able to identify and address psychosocial issues. The manual provides key information about disease management and skills training and is designed to facilitate self management. Using the ‘Whole Person Model’, the manual encourages the reader to consider how their body, their thoughts and feelings, and their health behaviours are all interdependent. It helps people to look at their thinking and learn strategies to improve their mood and make lifestyle changes.
Intervention code [1] 286775 0
Treatment: Other
Intervention code [2] 286903 0
Lifestyle
Comparator / control treatment
Participants will receive standard written information (e,g., fact sheets) on diabetes management. This will be provided at baseline only and will not include involvement with a Health Coach.
Control group
Active

Outcomes
Primary outcome [1] 289138 0
Diabetes control (HbA1c)

Timepoint [1] 289138 0
Baseline, and at 13 and 26 weeks following baseline assessment
Primary outcome [2] 289139 0
Weight (kg).

Weight will be measured using digital personal scales.

Timepoint [2] 289139 0
Baseline and at 13 and 26 weeks following baseline assessment
Primary outcome [3] 289140 0
Mood - Mean score of the Depression, Anxiety and Stress Scale (DASS total score) and of the Demoralisation Scale (DS total score)
Timepoint [3] 289140 0
Baseline and at 13 and 26 weeks following baseline assessment
Secondary outcome [1] 301910 0
Exercise level (steps taken on a pedometer over three days).

These three days can be any three days within a seven day period.
Timepoint [1] 301910 0
Baseline and at 13 and 26 weeks following baseline assessment
Secondary outcome [2] 301911 0
Use of self-management principles and practices (self efficacy) - as indicated by the Diabetes Empowerment Scale
Timepoint [2] 301911 0
Baseline and at 13 and 26 weeks following baseline assessment
Secondary outcome [3] 301912 0
Psychosocial well-being (social support, quality of life) - as indicated by the Perceived Social Support Scale and the EQ5D.

Timepoint [3] 301912 0
Baseline and at 13 and 26 weeks following baseline assessment

Eligibility
Key inclusion criteria
Adult age – 18 years or over

Diagnosis of type 2 diabetes between 2 and 10 years

BMI 20 to 40.

Not currently on insulin

English fluency in speech and reading sufficient to read and understand manual (written to Grade 6 level)

Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive impairment or other infirmity which precludes participation

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)
Following recruitment and completion of baseline assessment participants will be allocated to active intervention or control based on a computer generated randomisation controlled by an external statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis will examine for change over time, with the hypothesis being that participants in the active intervention will improve significantly on the primary outcome measures over the time of the intervention in comparison with the control group, and that this change will be sustained for the follow-up period until 26 weeks.

The main statistical method to be used here will be an Analysis of Covariance (ANCOVA).

A power analysis has been conducted on the 3 key primary outcome measures; weight, HbA1c and the Depression, Anxiety & Stress Scale (DASS). This analysis was based on the clinically significant changes being sought which include:

1. Mean 4.4.kg reduction (weight)
2. 0.7% reduction (HbA1c) and,
3. 25% reduction in total DASS score, e.g., from 20 to 15.

Power analysis was calculated using GPower. On the basis of this analysis, and assuming a drop out rate of 15% based on prior experience, we estimate that a recruited sample of 180 will be required and sufficient to give the requisite power.

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)
VIC

Funding & Sponsors
Funding source category [1] 286934 0
Charities/Societies/Foundations
Name [1] 286934 0
Bupa Foundation
Address [1] 286934 0
Bupa, 600 Glenferrie Road, HAWTHORN VIC 3122

Country [1] 286934 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Medical Centre
246 Clayton Road,
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 285723 0
Hospital
Name [1] 285723 0
Monash Health
Address [1] 285723 0
246 Clayton Road, Clayton, VIC 3168
Country [1] 285723 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288990 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 288990 0
Monash Medical Centre
246 Clayton Road,
Clayton, VIC 3168
Ethics committee country [1] 288990 0
Australia
Date submitted for ethics approval [1] 288990 0
Approval date [1] 288990 0
10/08/2012
Ethics approval number [1] 288990 0
12135B

Summary
Brief summary
This project will evaluate an integrated 'chronic disease self-management' (CDSM) education program for people with type 2 diabetes mellitus. The program is constructed around a patient manual, the working through of which is facilitated by a trained health coach over a 7 week period. The manual provides key information about disease management and skills training. Using the "Whole Person Model" the manual encourages the reader to consider how their body, their thoughts and feelings, and their health behaviours all affect each other. It helps people look at their thinking and learn strategies to improve their mood and make lifestyle changes.

The aim of the proposed project is to evaluate, through a randomised controlled trial, the efficacy of the program. It is hypothesised that people allocated to the intervention (completion of the program) will demonstrate greater improvements in self efficacy in their disease management, health outcomes, well-being and quality of life than the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38686 0
Prof David Clarke
Address 38686 0
Monash Medical Centre,
246 Clayton Rd
Clayton, VIC 3168
Country 38686 0
Australia
Phone 38686 0
+61 03 9594 1479
Fax 38686 0
+61 03 9594 6499
Email 38686 0
david.clarke@monash.edu
Contact person for public queries
Name 38687 0
Prof David Clarke
Address 38687 0
Monash Medical Centre,
246 Clayton Rd
Clayton, VIC 3168
Country 38687 0
Australia
Phone 38687 0
+61 03 9594 1479
Fax 38687 0
+61 03 9594 6499
Email 38687 0
david.clarke@monash.edu
Contact person for scientific queries
Name 38688 0
Prof David Clarke
Address 38688 0
Monash Medical Centre,
246 Clayton Rd
Clayton, VIC 3168
Country 38688 0
Australia
Phone 38688 0
+61 03 9594 1479
Fax 38688 0
+61 03 9594 6499
Email 38688 0
david.clarke@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data that underlie the results reported (text, tables, figures and appendices).
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following article publication.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal.
How or where can data be obtained?
Following publication, proposals should be directed to david.clarke@monash.edu. To gain access, data requestors will need to sign a data access agreement.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Analytic code
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary