Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000386033
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
13/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Online decision support system for consumer health
Scientific title
A randomised controlled trial to assess the effectiveness of an online decision support system on uptake of influenza vaccination and consumer healthcare management
Secondary ID [1] 251723 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uptake of influenza vaccination (annual seasonal or H1N1) over the respiratory infections season (i.e. winter season) 257335 0
Condition category
Condition code
Public Health 257478 257478 0 0
Health service research
Public Health 257498 257498 0 0
Health promotion/education
Infection 257499 257499 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* healthy.me is an online system developed at the Centre for Health Informatics,University of New South Wales, Sydney, Australia. It contains information about influenza vaccination; an online tool for consumers to book an appointment at the University Health Service for influenza vaccination; and an online personal health record for participants to record their appointments, medications and other health-related information.

* All participants are required to complete a 5-minute mandatory online tutorial about the healthy.me system before commencing the study.

* Duration of study is expected to be 6 months. Period of access to the website will vary depending on date of participant enrollment.
Intervention code [1] 256448 0
Prevention
Intervention code [2] 256449 0
Behaviour
Comparator / control treatment
Participants in the control group receive usual care and delayed access to healthy.me by approximately 6 months.
Control group
Active

Outcomes
Primary outcome [1] 258392 0
Primary Outcome 1: number of participants receiving influenza vaccination during the study period.
Timepoint [1] 258392 0
Timepoint: Study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via self-reports and de-identified clinical audit)
Secondary outcome [1] 264129 0
Secondary Outcome 1: number of participants experiencing symptoms of influenza-like illness (ILI) during the study, (as defined by case definitions of influenza issued by NSW Health and Centers for Disease Control and Prevention (CDC) as of 26 March 2010)
Timepoint [1] 264129 0
Timepoint: (i). monthly from study commencement (via self-reports); and (ii). at study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via de-identified clinical audit)
Secondary outcome [2] 264130 0
Secondary Outcome 2: number of participants using health care service or medications due to ILI symptoms
Timepoint [2] 264130 0
Timepoint: (i). monthly from study commencement (via self-reports); and (ii). at study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via self-reports and de-identified clinical audit)
Secondary outcome [3] 264131 0
Secondary Outcome 3: number of participants absent from or experiencing impairment in work or study due to ILI symptoms
Timepoint [3] 264131 0
Timepoint: (i). monthly from study commencement (via self-reports); and (ii). at study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via de-identified clinical audit)
Secondary outcome [4] 264132 0
Secondary Outcome 4: number of participants expressing positive or negative attitudes or experiences towards influenza vaccination (e.g. self-reported reasons for those unwilling or unable to receive a vaccine, such as unavailability of appointments, received professional / informal advice against it, or recent publicity about adverse effects of vaccines)
Timepoint [4] 264132 0
Timepoint: study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via self-reports)
Secondary outcome [5] 264133 0
Secondary Outcome 5: patterns of usage of healthy.me (e.g. number and timing of enquiries, duration of interactive sessions, uptake of specific functions, such as accessing online information, appointment booking function, and other personal health record functions.
Timepoint [5] 264133 0
Timepoint: study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via system logs)

Eligibility
Key inclusion criteria
1. Aged 18 or above
2. Access to the Internet and email on a monthly basis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants who self-reported having received an influenza vaccination in 2010 before commencing the study will be excluded from analysis.
2. Participants who self-reported to be influenced by other participants undergoing the study when deciding to undertake influenza vaccination during the study will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
* The intervention will not modify in any way the standard procedures of healthcare provision by the University Health Service
* Interested healthcare consumers are directed to a website with detailed information about the study, where they can provide consent and self-enrol into the study online.
* Allocation to control or intervention group will be concealed according to a computer generated block randomization list. (Investigators will be blinded in the group allocation process).
* The randomization sequence generation, participant recruitment and the group allocation processes in this study are computerised and do not involve human interventions from the investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
* Eligible healthcare consumers are randomly assigned to the intervention or control group using a computer generated random number sequence in randomly assigned blocks with intervention allocation ratio of 1:1.
* The block randomisation sequence is pre-generated using a computerized random-number generator before commencing participant recruitment.
* For each level of strata, a random sequence of study group allocations is generated and each level of strata is numbered consecutively.
* As each consumer completes the online study enrolment process, he/she receives the next consecutive number in his or her stratum, which automatically assigns the consumer to the intervention or control group without additional intervention from the investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256937 0
Charities/Societies/Foundations
Name [1] 256937 0
The HCF Health and Medical Research Foundation
Country [1] 256937 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The HCF Health and Medical Research Foundation
Address
HCF Health and Medical Research Foundation
c/o The Hospitals Contribution Fund of Australia Limited
GPO Box 4242
Sydney NSW 2001
Country
Australia
Secondary sponsor category [1] 256204 0
None
Name [1] 256204 0
Address [1] 256204 0
Country [1] 256204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258940 0
University of New South Wales (UNSW) Human Research Ethics Committee (HREC)
Ethics committee address [1] 258940 0
Ethics Secretariat,
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
Ethics committee country [1] 258940 0
Australia
Date submitted for ethics approval [1] 258940 0
Approval date [1] 258940 0
10/05/2010
Ethics approval number [1] 258940 0
10109

Summary
Brief summary
The aim of this project is to assess the effectiveness of an online system designed for healthcare consumers, called healthy.me, to support healthcare management. healthy.me provides consumers condition specific information, as well as online tools to manage their care including a personal health record. We hypothesise that use of healthy.me will improve the uptake of preventative activities and this randomized controlled trial will specifically test whether system use is associated with an increased rate of influenza vaccination among university students and staff over the respiratory infections season.
Trial website
www2.chi.unsw.edu.au/healthy.me
Trial related presentations / publications
* Coiera E, Lau A.Y.S., Anvari F, Sacks G (2010). healthy.me: an online research platform to support consumer health management. Health Informatics Conference; 2010; Melbourne Australia.
* Coiera, E., Lau, A.Y.S., Anvari, F. (2010): healthy.me: an online environment to support consumer health decisions and management. Consumer-Centred Health Care: Policy Innovation Empowerment National Conference, 22/23 March 2010 Melbourne.
* Coiera, E., Lau, A.Y.S., Tsafnat, G., Sintchenko, V., Magrabi, F. (2009). The changing nature of clinical decision support systems: a focus on consumers, genomics, public health and decision safety. 2009 International Medical Informatics Association (IMIA) Yearbook, 2009(1), 84-95.
* Lau A.Y.S., Kwok T.M.Y. (2009) Social features in online communities for healthcare consumers - a review. Third International Online Communities and Social Computing Conference; 2009; San Diego, CA, USA. In: Ozok, A.A., Zaphiris, P. (eds.): Online Communities, LNCS 5621. Springer-Verlag, Berlin Heidelberg (2009) 682-689.
* Coiera, E., Lau, A.Y.S., Anvari, F. (2009): healthy.me: an online research platform to support consumer health decision making. eResearch Australasia, Sydney, Australia.
* Lau, A.Y.S.: healthy.me: a Facebook for Healthcare (2009). Advances in Public Health and Health Services Research at UNSW 1st Annual Symposium, Sydney, Australia.
* Coiera, E., Lau, A.Y.S., Anvari, F. (2009): A "Facebook" for healthcare. HCSNet workshop on Social Technologies Applications for Health and Medicine, Melbourne, Australia.
Public notes

Contacts
Principal investigator
Name 31142 0
Address 31142 0
Country 31142 0
Phone 31142 0
Fax 31142 0
Email 31142 0
Contact person for public queries
Name 14389 0
Prof. Enrico Coiera
Address 14389 0
Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
Country 14389 0
Australia
Phone 14389 0
+ 61 2 9385 3586
Fax 14389 0
+ 61 2 9385 8692
Email 14389 0
e.coiera@unsw.edu.au
Contact person for scientific queries
Name 5317 0
Dr Annie Lau
Address 5317 0
Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
Country 5317 0
Australia
Phone 5317 0
+ 61 2 9385 8891
Fax 5317 0
+ 61 2 9385 8692
Email 5317 0
a.lau@unsw.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
Dimensions AIProtocol for a randomised controlled trial examining the impact of a web-based personally controlled health management system on the uptake of influenza vaccination rates2012https://doi.org/10.1186/1472-6963-12-86
N.B. These documents automatically identified may not have been verified by the study sponsor.