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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]

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)

Condition category

Condition code

Public Health

Health service research

Public Health

Health promotion/education

Infection

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]

Prevention

Intervention code [2]

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]

Primary Outcome 1: number of participants receiving influenza vaccination during the study period.

Timepoint [1]

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]

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]

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]

Secondary Outcome 2: number of participants using health care service or medications due to ILI symptoms

Timepoint [2]

Secondary outcome [3]

Secondary Outcome 3: number of participants absent from or experiencing impairment in work or study due to ILI symptoms

Timepoint [3]

Secondary outcome [4]

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]

Timepoint: study completion (end of influenza season in NSW Australia, approximately six months from study commencement) (measured via self-reports)

Secondary outcome [5]

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]

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]

Charities/Societies/Foundations

Name [1]

The HCF Health and Medical Research Foundation

Address [1]

HCF Health and Medical Research Foundation
c/o The Hospitals Contribution Fund of Australia Limited
GPO Box 4242
Sydney NSW 2001

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales (UNSW) Human Research Ethics Committee (HREC)

Ethics committee address [1]

Ethics Secretariat,
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales  NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/05/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof. Enrico Coiera

Address

Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia

Country

Australia

Phone

+ 61 2 9385 3586

Fax

+ 61 2 9385 8692

[email protected]

Contact person for scientific queries

Name

Dr Annie Lau

Address

Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia

Country

Australia

Phone

+ 61 2 9385 8891

Fax

+ 61 2 9385 8692

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Protocol for a randomised controlled trial examining the impact of a web-based personally controlled health management system on the uptake of influenza vaccination rates	2012	https://doi.org/10.1186/1472-6963-12-86

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