Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000210279
Ethics application status
Approved
Date submitted
3/02/2009
Date registered
27/04/2009
Date last updated
16/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of a patient narrative intervention on self-efficacy and self-care behaviours in people with type 2 diabetes.
Scientific title
A randomised-controlled trial to evaluate the impact of a patient narrative intervention on self-efficacy and self-care behaviours in Australians with type 2 diabetes.
Secondary ID [1] 288172 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adults with type 2 diabetes 4263 0
Condition category
Condition code
Metabolic and Endocrine 4488 4488 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A parallel-group, wait-list, randomised-controlled trial was conducted to evaluate an intervention which presented a range of ‘role model’s’ experiences about managing Type 2 Diabetes. The Patient Narrative intervention involved viewing a DVD which told the stories of 9 'role models'. The role models, who were all actual patients, told their stories of day to day management of type 2 diabetes, sharing their experiences of successful self-management. The role models discussed: Life before type 2 diabetes; Facing diagnosis; Self management of type 2 diabetes; Healthy eating and exercise; Insulin and management issues; Involvement of family and friends; Getting support; Closing thoughts. The DVD was presented in 3 modules, and was accompanied by a printed guide for learning. Patients were instructed to view one module per week for 3 weeks, at a convenient time and place for them. Duration of intervention: 3 x 30 minute modules, 1 module per week. The participants were able to revisit the DVD at their leisure. Total exposure to the DVD material, up to 4 weeks.
Intervention code [1] 3987 0
Behaviour
Intervention code [2] 3988 0
Lifestyle
Comparator / control treatment
The comparator / control treatment was five standard informational brochures supplied by Diabetes Australia.
The Diabetes Australia information brochures were selected from the ‘Talking Diabetes’ series:
No. 10 - Diabetes & Good health
No. 15 - Food choices for people with diabetes
No. 27 - Physical activity & type 2 diabetes
No. 30 – Reading food labels
No. 42 – What is diabetes?

The material was a print/static description of diabetes and its management, as distinct from the narrative intervention where role models talked about their experiences in everyday diabetes care tasks in the form of a DVD.
The information brochures were given to study participants at the start of the study, and the participant was able to keep the material indefinitely as reference material.
Control group
Active

Outcomes
Primary outcome [1] 5369 0
Self-efficacy was the primary outcome. This was measured with the Australian/English Diabetes Management Self-efficacy Scale. This questionnaire comprises 20 items that assess the extent to which respondents are confident that they can manage their blood sugar level, foot care, medication, diet and level of physical activity. The questions in the 20 item questionnaire are rated on an 11 point Likert scale. The 20 items are then summed to produce a single score as a measure of self efficacy. The scores can range from 0-200, with higher scores indicating greater level of self-efficacy.
Timepoint [1] 5369 0
4 weeks upon receipt of the intervention materials by the subjects.
Secondary outcome [1] 9025 0
Diabetes self-care. This was measured using the 'Summary of Diabetes Self-Care Activities Measure' (SDSCA). The SDSCA is an 11 item questionnaire for the assessment of general diet, specific diet, exercise, blood glucose testing, foot care and smoking. The questions in the 11 item questionnaire ask the frequency of the above self care activities during the past 7 days.
Timepoint [1] 9025 0
6 months upon receipt of the intervention materials by the subjects.

Eligibility
Key inclusion criteria
Newly diagnosed type 2 diabetes patients
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Does not have access to a DVD player
Does not understand written or spoken English

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)
New National Diabetes Services Scheme (NDSS) registrants living in Victoria and New South Wales in Australia were sent a study information pack inviting them to participate in the study if they met the following inclusion criteria:
They had agreed to participate in research when they registered with the NDSS
They were aged between 30 and 70
They had been diagnosed by their doctor with type 2 diabetes within the previous 6 months
They could understand written and spoken English

Recruitment of the sample was conducted on a monthly basis until the sample size was achieved. Each month, a list of eligible new registrants was compiled by Diabetes Australia for the study. Diabetes Australia’s guidelines for protection of personal information were followed to protect the privacy of NDSS registrants. This meant that the personal details of new registrants were not made available to the researchers directly. It was a requirement that initial contact with NDSS registrants was made through an independent mailing house with information about the intention and methodology of the study. The Diabetes Australia VIC in-house mailing department was approached by the researcher for this purpose.

Approval was received from Diabetes Australia VIC and Diabetes Australia to use the in-house mailing department to receive the monthly registrant database from the NDSS and to apply mailing labels to the study invitation packs.

Recruitment was conducted over an 11-month period from September 2009 to June 2010.

Registrants who were willing to participate in the study were asked to sign and return the consent form and completed baseline questionnaires to the researcher. As the documents were received, the participants were allocated an ID number and their baseline data were entered into the study database. On a monthly basis, study participants were randomised into the intervention or control group and posted the appropriate intervention materials with accompanying instructions for their completion and return.

The Statistical Consulting Centre (SCC) at the University of Melbourne conducted randomisation at arm’s length from the researcher. Each month, the ID number, surname and date of birth of new study participants were emailed to the SCC. Surname and date of birth were included to enable the SCC to cross check allocations against the study database in the future.




Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Statistical Consulting Centre used block randomisation. The randomisation was done using blocks of varying length, between 4 and 12. The order of the blocks was randomised, and the order of the allocations within each block was also randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Baseline: Descriptive statistics were used to analyse the characteristics of the study
sample, and a two-sided t-test was conducted to analyse the mean differences between
the groups in the outcome variables. Predictors for self-efficacy and self-care were also
examined.

Time 2 (4 weeks): t-tests were conducted to compare the difference between the groups
in the means of the changes in the outcome variables from baseline to Time 2.

Time 3 (6 months): t-tests were again conducted to compare the difference between the
groups in the means of the changes in the outcome variables from baseline to Time 3.

Time 2 and Time 3: A repeated measures analysis of covariance (ANCOVA) of each
of the self-care measures and self-efficacy at Time 2 and Time 3 was conducted,
adjusting for baseline differences that were significant at the 5% level (self-efficacy,
depression, exercise and footcare). This analysis was conducted to determine the overall
treatment effect for each outcome variable across the trial period. A general linear
model was fitted to account for the various types of explanatory variables (categorical
and numeric). The strategy was to fit a model to the Time 2 and Time 3 outcomes using
all explanatory variables, and report the results. Taking these results into account, a
repeated measures ANCOVA was fitted, including only those explanatory variables that
appeared to have a marked effect in the separate analyses, thereby adjusting for baseline
differences.

As there was some missing data at Time 2 and Time 3, the strategy for data analysis involved:
Analysis with complete cases
Analysis based on multiple imputation

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2009
Actual
4/09/2009
Date of last participant enrolment
Anticipated
Actual
29/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
550
Accrual to date
Final
670
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 4719 0
University
Name [1] 4719 0
The University of Melbourne
Country [1] 4719 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The Centre for Health Policy, Programs and Economics
Level 4, 207 Bouverie Street
Carlton VIC 3010
Country
Australia
Secondary sponsor category [1] 4004 0
None
Name [1] 4004 0
Address [1] 4004 0
Country [1] 4004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6754 0
Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 6754 0
Ethics committee country [1] 6754 0
Australia
Date submitted for ethics approval [1] 6754 0
Approval date [1] 6754 0
27/02/2009
Ethics approval number [1] 6754 0
HREC 0829859

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

Contacts
Principal investigator
Name 29243 0
Dr Tina Campbell
Address 29243 0
275 Inkerman Street St Kilda East VIC 3183
Country 29243 0
Australia
Phone 29243 0
+61 (0) 418 536 596
Fax 29243 0
Email 29243 0
[email protected]
Contact person for public queries
Name 12490 0
Tina Campbell
Address 12490 0
275 Inkerman Street St Kilda East VIC 3183
Country 12490 0
Australia
Phone 12490 0
+61 (0) 418 536 596
Fax 12490 0
Email 12490 0
[email protected]
Contact person for scientific queries
Name 3418 0
Tina Campbell
Address 3418 0
The Centre for Health Policy, Programs and Economics
Level 4, 207 Bouverie Street
Carlton VIC 3010
Country 3418 0
Australia
Phone 3418 0
+61 (0) 418 536 596
Fax 3418 0
Email 3418 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
SourceTitleYear of PublicationDOI
EmbaseThe impact of patient narratives on self-efficacy and self-care in Australians with type 2 diabetes: stage 1 results of a randomized trial.2015https://dx.doi.org/10.1093/heapro/dat058
N.B. These documents automatically identified may not have been verified by the study sponsor.