ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

Behaviour

Intervention code [2]

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]

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]

4 weeks upon receipt of the intervention materials by the subjects.

Secondary outcome [1]

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]

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]

University

Name [1]

The University of Melbourne

Address [1]

The Centre for Health Policy, Programs and Economics
Level 4, 207 Bouverie Street
Carlton VIC 3010

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health Sciences Human Ethics Sub-Committee

Ethics committee address [1]

The University of Melbourne
Human Research Ethics,
Melbourne Research Office,
Level 5, Alan Gilbert Building,
161 Barry St. 
CARLTON VIC 3053

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/02/2009

Ethics approval number [1]

HREC 0829859

Summary

Brief summary

The growing burden of chronic conditions has been the catalyst for the development of scalable, cost-effective chronic disease management and prevention programmes. Patient narrative communication, or storytelling, is emerging as a component of these programs despite a dearth of quantitative research, utilising rigorous study methods, to examine the effect they have on behaviour change.  This thesis presents the findings of a randomized-controlled trial (RCT) which evaluated the impact of patient narratives on the study outcomes, self-efficacy and self-care behaviours.

Trial website

Trial related presentations / publications

Article:

Tina Campbell, D. Dunt, J.L. Fitzgerald, I. Gordon.  The impact of patient narratives on self-efficacy and self-care in Australians with type 2 diabetes: stage 1 results of a randomised trial. Health Promotion International, 28 August 2013.

Conference presentations:

Campbell, C. (Tina), Dunt, D., Hsu-Hage, B. (2008, Oct). The use of narrative in patient education and chronic disease self-management. School of Rural Health Research Conference, October 2008. The University of Melbourne. Awarded ‘Most Promising Paper’.

Campbell, C. (Tina), Dunt, D., Fitzgerald, J. (2010, May). The role of patient and carer experience in contemporary health promotion. Cebit eHealth Conference. Sydney Convention & Exhibition Centre, Sydney, NSW.

Campbell, C. (Tina), Dunt, D., Fitzgerald, J. (2011, Aug). A randomised controlled trial evaluating the effect of patient narratives on self-efficacy and self-care behaviour in people with type 2 diabetes – stage 1 findings. The 7th Annual National Disease Management Conference, ‘Partnerships for Chronic Care: Patients, Services, Policy’, National Convention Centre, Canberra, ACT.

Campbell, C. (Tina), Dunt, D., Fitzgerald, J., Gordon, I. (2012, Oct) The effect of a patient narrative intervention on self-efficacy and self-care behaviours in people with type 2 diabetes – final results of a RCT. Medicine X. Stanford University, CA, USA.

Campbell, C (Tina). Mobility for clinical and educational purposes. Cebit eHealth Conference. (Keynote – 22-24 May 2012). Sydney Convention & Exhibition Centre, Sydney, NSW.

Campbell, C (Tina). Using mobile technology to share patient and clinician knowledge. 9th Annual National Disease Management Conference: CDM: Innovation, Adaption & Evolution (Keynote speaker). 22nd - 23rd August 2013. InterContinental Hotel, Sydney, NSW

Workshops and seminars:

Campbell, C (Tina). ‘The role of narrative in chronic disease self-management programs’. Chronic Illness Alliance. Presentation to the Chronic Disease Self-Management Special Interest Group meeting (29 October, 2009). Melbourne, Australia.

Campbell, C (Tina). ‘Narrative Communication for CDSM education and training’. General Practice Victoria. Chronic Disease Self-management: Where to now? How to build and sustain CDSM integration in my program area. Workshop (24 March, 2010). Melbourne, Australia

Campbell, C (Tina). ‘Patient Narrative Communication’. Victorian Department of Health. Invitation to present to the Partnerships and Primary Health, Integrated Care Branch team on  (21 February, 2013). Melbourne, Australia.

Campbell, C (Tina). ‘The use of 'patient experience' to inform health policy and program development: challenges and opportunities’. Victorian Department of Health. Invitation to present at the ‘Better Evidence Initiative’ seminar series (31st May 2013). Melbourne, Australia.

Campbell, C (Tina). Invitation to speak at the mHealth2013 workshop, APuHC University of NSW, 5 July 2013. ‘Mobile apps for diabetes self-management: enabling access to Australian patient and carer experiences’. Kensington Campus, UNSW.

Campbell, C (Tina). Presentation to the Royal District Nursing Service (RDNS Institute). 31 October 2013. ‘Using patient and carer experiences to improve patient-centered care’.  Melbourne, Australia.

Public notes

Contacts

Principal investigator

Name

Dr Tina Campbell

Address

275 Inkerman Street St Kilda East VIC 3183

Country

Australia

Phone

+61 (0) 418 536 596

Fax

tina.c@realtimehealth.com

Contact person for public queries

Name

Tina Campbell

Address

275 Inkerman Street St Kilda East VIC 3183

Country

Australia

Phone

+61 (0) 418 536 596

Fax

tina.c@realtimehealth.com

Contact person for scientific queries

Name

Tina Campbell

Address

The Centre for Health Policy, Programs and Economics
Level 4, 207 Bouverie Street
Carlton VIC 3010

Country

Australia

Phone

+61 (0) 418 536 596

Fax

tina.c@realtimehealth.com

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

Source	Title	Year of Publication	DOI
Embase	The impact of patient narratives on self-efficacy and self-care in Australians with type 2 diabetes: stage 1 results of a randomized trial.	2015	https://dx.doi.org/10.1093/heapro/dat058

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically