Trial Review

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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
ACTRN12616000135415
Ethics application status
Approved
Date submitted
2/02/2016
Date registered
5/02/2016
Date last updated
21/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Health literacy following an educational intervention in older Australians
Scientific title
Can an educational intervention improve health literacy and decision making about supporting self-advice and decision making among older Australians: a randomised controlled trial
Secondary ID [1] 288469 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy volunteers 297503 0
Condition category
Condition code
Alternative and Complementary Medicine 297694 297694 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health education.
Participants will be invited to watch the three module intervention in their home accessing the web link by a password protected code, or CD ROM over three weeks. The hardware required to use the education intervention will be by internet access, or for those using CD ROM a television or DVD player. Users will be able to pace their learning with back, next, end, replay, pause and play buttons. The duration of teaching module will be 30 minutes. Participants are able to access the intervention as often as they wish.
The content of the intervention will comprise of three modules and include materials and resources to inform the consumer about where to identify and obtain reliable information and credible sources of information about complementary medicines (CM), appraisal of health information, ability to find good information, and navigating the CM healthcare system. Information will be presented online using an education delivery package, and a video with a voice over.
Participants will be invited to read the three modules. One module involves interactive completion of questions using a multiple choice format.
Data will be collected from the web based intervention that document the length of time the web resource was used, and the number of times accessed.
Intervention code [1] 293804 0
Other interventions
Comparator / control treatment
An information booklet containing the same information as the web/CD ROM package but presented using only text will be compiled. The text will be set at 18 point Arial typeface and is written at a 6th grade reading level. We will encourage each module is completed over a one week period, in total three weeks will be allocated to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 297230 0
Complementary medicine decision self-efficacy using the Preparation for Decision Making Scale
Timepoint [1] 297230 0
3 weeks and 2 months after the intervention starts
Secondary outcome [1] 320415 0
health literacy using the Health Literacy Questionnaire
Timepoint [1] 320415 0
3 weeks and 2 months after the intervention starts
Secondary outcome [2] 320416 0
change in perception of risk measured by two questions examining views on the safety and efficacy designed specifically for the study.
Timepoint [2] 320416 0
3 weeks and 2 months after the intervention starts
Secondary outcome [3] 320417 0
knowledge assessed by presentation of a vignette to study participants, and their responses assessed by study staff.
Timepoint [3] 320417 0
3 weeks and 2 months after the intervention starts
Secondary outcome [4] 320418 0
Health seeking behaviour assessed by practical follow up use of the resources presented. This will be assessed by self report from participants in response to questions designed specifically for the study
Timepoint [4] 320418 0
3 weeks and 2 months after the intervention starts

Eligibility
Key inclusion criteria
men and women aged greater than 65 years, living in the Greater Western Sydney Region, and the Southern Highlands, New South Wales
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
unable to communicate in English, living in a long term care facility

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)
Concealed opaque envelop
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
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
An intention to treat approach will compare differences in the primary and secondary endpoints between groups. Chi square and repeated analysis of variance will be used to identify differences between groups for categorical and continuous variables respectively.

A sample size of 168 subjects, 84 per group is needed for this trial. The sample size effect is based on published data. It was estimated that a moderate effect size would be obtained (ie Cohen eta=0.5) responsive to change in the decision making before and after the intervention. With alpha set at 0.05, and power at 0.8 (80% chance that the expected effect size would be significant), a minimum sample size of 70 per group would be required. Allowing for a 20% loss, we will recruit 168 subjects to the trial (84 per group).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2016
Actual
1/08/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
6/02/2017
Date of last data collection
Anticipated
Actual
31/05/2017
Sample size
Target
168
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292812 0
Charities/Societies/Foundations
Name [1] 292812 0
IRT Foundation
Country [1] 292812 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith
NSW2751
Country
Australia
Secondary sponsor category [1] 291553 0
None
Name [1] 291553 0
Address [1] 291553 0
NA
Country [1] 291553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294314 0
University of Western Sydney
Ethics committee address [1] 294314 0
Locked Bag 1797
Penrith
NSW 2751
Ethics committee country [1] 294314 0
Australia
Date submitted for ethics approval [1] 294314 0
28/09/2015
Approval date [1] 294314 0
28/10/2015
Ethics approval number [1] 294314 0
H11361
Ethics committee name [2] 294315 0
University of Notre Dame
Ethics committee address [2] 294315 0
33 Phillimore St (PO Box 1225), Fremantle, WA 6959
Ethics committee country [2] 294315 0
Australia
Date submitted for ethics approval [2] 294315 0
Approval date [2] 294315 0
16/12/2015
Ethics approval number [2] 294315 0
014145S

Summary
Brief summary
Older Australians are high consumers of complementary medicines (CMs) such as nutritional supplements (minerals and vitamins) and herbal medicines. CM may offer a way for older people to cope with their ill health, to engage in maintaining their health, and to improve their quality of life. National policy states consumers are responsible for: asking for and utilising information, to make decisions and take actions that enable medicines to be chosen and used wisely, being aware of the risks and benefits of medicines, developing skills and confidence to use medicines appropriately, and seeking help to solve problems when they arise. Our study identified older Australians had difficulties navigating the health care system to discuss and use CM; finding good CM information, and appraising this information. Our findings highlight the potential for older vulnerable people to be misinformed and to make inappropriate self-care decisions. To facilitate older Australians to take an active role in their health, we will develop and evaluate a novel educational intervention based on our preliminary research to support self-advice, good decision making, and improve health literacy skills. One hundred and sixty residents in Western Sydney, NSW will be invited to participate in a randomised controlled trial to evaluate the effect of an education intervention to increase their decision making regarding CM and self-care, health literacy and their ability to actively engage and navigate the health care systems.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63266 0
Prof Caroline Smith
Address 63266 0
NICM
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 63266 0
Australia
Phone 63266 0
+61246203777
Fax 63266 0
Email 63266 0
caroline.smith@westrensydney.edu.au
Contact person for public queries
Name 63267 0
Prof Caroline Smith
Address 63267 0
NICM
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 63267 0
Australia
Phone 63267 0
+61246203777
Fax 63267 0
Email 63267 0
caroline.smith@westernsydney.edu.au
Contact person for scientific queries
Name 63268 0
Prof Caroline Smith
Address 63268 0
NICM
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 63268 0
Australia
Phone 63268 0
+61246203777
Fax 63268 0
Email 63268 0
caroline.smith@westernsydney.edu.au

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
EmbaseAn education intervention to improve decision making and health literacy among older Australians: a randomised controlled trial.2019https://dx.doi.org/10.1186/s12877-019-1143-x
EmbaseAn education intervention to improve health literacy and decision making about supporting self-care among older Australians: A study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-017-2182-2
N.B. These documents automatically identified may not have been verified by the study sponsor.