ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000459820

Ethics application status

Approved

Date submitted

24/04/2012

Date registered

24/04/2012

Date last updated

27/02/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Web-based Personal Health Management System to Promote Sexually Transmissible Infections (STI) screening

Scientific title

A randomised controlled trial to assess the effectiveness of a web-based personal health management system in increasing the uptake of Sexually Transmissible Infections (STI) screening and engagement with health services for sexual health concerns in young people.

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Uptake of Sexually Transmissible Infections (STI) screening in young people aged 18-29

Condition category

Condition code

Public Health

Health service research

Public Health

Health promotion/education

Infection

Sexually transmitted infections

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 sexual health and STI screening; an online tool for consumers to book an appointment at the University Health Service for sexual health concerns or STI screening; 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. * Following completion of the online tutorial, the frequency in which the healthy.me system will be used is at the discretion of the participants. * Duration of study is expected to be 3-6 months. Period of access to the website will vary depending on date of participant enrolment.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Comparator / control treatment

Participants in the control group receive access to the healthy.me system and delayed access to the sexual health content on healthy.me by approximately 3 months.

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome 1: number of participants who receive testing for sexually transmitted infections during the study period.

Timepoint [1]

Timepoint: Study completion (measured via self-reports and, potentially, de-identified clinical audit)

Secondary outcome [1]

Secondary Outcome 1: number of participants who access health services for sexual health concerns during the study period.

Timepoint [1]

Timepoint: Study completion (measured via self-reports and, potentially, de-identified clinical audit)

Secondary outcome [2]

Secondary Outcome 2: number of participants who experience a change in their perceptions, attitudes or readiness regarding screening for sexually transmitted infections during the study period.

Timepoint [2]

Timepoint: Study completion (measured via self-reports)

Secondary outcome [3]

Secondary Outcome 3: 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, posting on the forum, appointment booking function, and other personal health record functions).

Timepoint [3]

Timepoint: Study completion (measured via system logs)

Eligibility

Key inclusion criteria

1. Aged 18-29
2. Access to the Internet and email on a monthly basis

Minimum age

18 Years

Maximum age

29 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

nil

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

Not yet recruiting

Date of first participant enrolment

Anticipated

8/03/2013

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

360

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Centre for Health Informatics

Address [1]

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

Country [1]

Australia

Primary sponsor type

University

Name

Centre for Health Informatics

Address

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

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 a web-based personal health management system, 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 screening activities and this randomized controlled trial will specifically test whether system use is associated with an increased rate of STI screening among young people aged 18-29 years.

Trial website

https://healthyme.med.unsw.edu.au/research/info.html

Trial related presentations / publications

* Lau AYS, Sintchenko V, Crimmins J, Magrabi F, Gallego B, Coiera E. Impact of a Web-based Personally Controlled Health Management System on Influenza Vaccination and Health Services Utilization Rates: A Randomised Controlled Trial. J Am Med Inform Assoc. 2012;(accepted: 2012/04/10). 
* Lau AYS, Sintchenko V, Crimmins J, Magrabi F, Gallego B, Coiera E. Protocol for a randomised controlled trial examining the impact of a web-based personal health management system on the uptake of influenza vaccination rates. BMC Health Services Research. 2012;(accepted: 2012/02/03).
* Lau AYS, Parker A, Early J, Sacks G, Anvari F, Coiera E. Comparative usage of a web-based personally controlled health management system and normal support: a case study in IVF. electronic Journal of Health Informatics (eJHI). 2012;(accepted: 2012/01/24).
* 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

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

e.coiera@unsw.edu.au

Contact person for public queries

Name

Nathan Mortimer

Address

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

Country

Australia

Phone

+61 4 3962 7051

Fax

nil

nathan.mortimer@unsw.edu.au

Contact person for scientific queries

Name

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

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

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Documents added automatically

No additional documents have been identified.

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