Trial from ANZCTR


Trial ID ACTRN12610000386033
Trial Status: Registered
Date Submitted: 10/05/2010
Date Registered: 13/05/2010
Retrospectively registered

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Public title Online decision support system for consumer health
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised controlled trial to assess the effectiveness of an online decision support system on uptake of influenza vaccination and consumer healthcare management
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Secondary ID [1] 251723 0
Nil
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UTN Nil
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Trial acronym
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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
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Condition category: Condition code:
Public Health Health service research
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257478 257478 0 0
Public Health Health promotion/education
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257498 257498 0 0
Infection Other infectious diseases
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257499 257499 0 0

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Descriptions 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.
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Intervention Code:
Prevention 256448 0
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Intervention Code:
Behaviour 256449 0
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Comparator / control treatment Participants in the control group receive usual care and delayed access to healthy.me by approximately 6 months.
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Control group Active
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Primary Outcome: Primary Outcome 1: number of participants receiving influenza vaccination during the study period. 258392 0
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Timepoint: 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) 258392 0
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Secondary Outcome: 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) 264129 0
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Timepoint: 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) 264129 0
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Secondary Outcome: Secondary Outcome 2: number of participants using health care service or medications due to ILI symptoms 264130 0
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Timepoint: 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) 264130 0
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Secondary Outcome: Secondary Outcome 3: number of participants absent from or experiencing impairment in work or study due to ILI symptoms 264131 0
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Timepoint: 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) 264131 0
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Secondary Outcome: 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) 264132 0
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Timepoint: Timepoint: study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via self-reports) 264132 0
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Secondary Outcome: 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. 264133 0
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Timepoint: Timepoint: study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via system logs) 264133 0
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Key inclusion criteria 1. Aged 18 or above
2. Access to the Internet and email on a monthly basis
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? Yes
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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.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features nil.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 10/05/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 600
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 256937 0
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Name: The HCF Health and Medical Research Foundation 256937 0
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Address: HCF Health and Medical Research Foundation
c/o The Hospitals Contribution Fund of Australia Limited
GPO Box 4242
Sydney NSW 2001
256937 0
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Country: Australia 256937 0
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Primary Sponsor Charities/Societies/Foundations
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Name: The HCF Health and Medical Research Foundation
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Address: HCF Health and Medical Research Foundation
c/o The Hospitals Contribution Fund of Australia Limited
GPO Box 4242
Sydney NSW 2001
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Country: Australia
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Secondary Sponsor: None 256204 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of New South Wales (UNSW) Human Research Ethics Committee (HREC) 258940 0
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Address: Ethics Secretariat,
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
258940 0
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Country: Australia 258940 0
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Approval Date: 10/05/2010 258940 0
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Submitted Date: 258940 0
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HREC: 10109 258940 0
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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.
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Trial website www2.chi.unsw.edu.au/healthy.me
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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.
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Prof. Enrico Coiera
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Address: Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
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Country: Australia
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Tel: + 61 2 9385 3586
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Fax: + 61 2 9385 8692
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Email: e.coiera@unsw.edu.au
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Contact person for scientific queries
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Name: Dr Annie Lau
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Address: Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
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Country: Australia
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Tel: + 61 2 9385 8891
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Contact person responsible for updating information
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Name: Dr Annie Lau
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Address: Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
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Country: Australia
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Email: a.lau@unsw.edu.au
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Addition Cancer fields
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