ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

ACTRN12612000716864

Ethics application status

Approved

Date submitted

4/07/2012

Date registered

5/07/2012

Date last updated

20/02/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluation of an online system for health, called Healthy.me, in patients with asthma

Scientific title

The effect of an internet intervention, called Healthy.me, on the use of written asthma action plans in patients with asthma

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Diagnosed asthma

Condition category

Condition code

Respiratory

Asthma

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Free use of the full version of the Healthy.me website to manage their asthma for 12 months. This version includes a Personally Controlled Health Management System (PCHMS) and social interaction features. Participants can enter descriptions of symptoms, spirometry measures, medication usage, report the asthma action plan, read tailored information about asthma, use forums and polls, access personal records, and book an appointment to see their healthcare professional.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Comparator / control treatment

Delayed access to Healthy.me by around 12 months. Participants can access generic information about asthma but are not able to get full access to Healthy.me until the end of study.

Control group

Active

Outcomes

Primary outcome [1]

Number of participants who have obtained, or have updated during the study, their personalized written asthma action plan. This outcome is assessed by pre- and post-study questionnaires and cross-validated by audits.

Timepoint [1]

at 12 months after randomisation

Secondary outcome [1]

Number of visits (planned and unplanned) to a GP, measured by questionnaires and cross-validated for the intervention group with log-files of usage of Healthy.me

Timepoint [1]

at 12 months

Secondary outcome [2]

Asthma control as measured by the Asthma Control Questionnaire

Timepoint [2]

monthly from baseline for 12 months

Secondary outcome [3]

Usage patterns (number and timing of hits, duration of access, uptake of specific functions) of Healthy.me

Timepoint [3]

at 12 months

Secondary outcome [4]

Asthma exacerbation as measured by the Asthma Exacerbation Questionnaire

Timepoint [4]

monthly from baseline for 12 months

Secondary outcome [5]

Impact of asthma (e.g. days lost from work or school, reported in post-study questionnaire and in the Asthma Control Questionnaire on a monthly basis)

Timepoint [5]

at 12 months

Secondary outcome [6]

Attrition rate for the use of Healthy.me

Timepoint [6]

at 12 months

Secondary outcome [7]

Healthy.me satisfaction and utilization assessed in post-study questionnaire or calculated from collected data

Timepoint [7]

at 12 months

Secondary outcome [8]

Number of participants adhering to a written asthma action plan, assessed in post-study questionnaire

Timepoint [8]

at 12 months

Eligibility

Key inclusion criteria

- Access to the Internet - Doctor diagnosis of asthma - Adequate English reading and written ability

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Internet-based recruitment methods will be used to invite patients with asthma to participate in the study: * advertisement on online noticeboards (e.g. Gumtree). * Promotion of the study on Facebook and Twitter * Asthma Foundation NSW will send an email to its members via its regular newsletters and/or other email mechanisms to inform them about the study. In addition, a call for participation will be advertised on their website. Participants meeting eligibility criteria will be invited to visit the study website and/or contact the researcher for participation and further information.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation to the intervention or control group according to a sequence generated by a computerized random-number generator. The randomisation will be stratified by gender and asthma severity (intermittent vs. persistent asthma). The randomisation sequence generation, participant enrolment and group allocation processes in this study are computerised online and do not involve interference from the investigators.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2013

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Centre for Health Informatics, UNSW

Address

Centre for Health Informatics
Level 1 AGSM Building (G27)
University of New South Wales
SYDNEY NSW 2052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW HREC

Ethics committee address [1]

University of New South Wales
SYDNEY NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/05/2012

Approval date [1]

05/06/2012

Ethics approval number [1]

HC12213

Summary

Brief summary

The aim of this project is to assess the efficacy of an online system designed for patients and health care consumers, called Healthy.me, to support health management. Healthy.me provides patients and consumer condition specific information, as well as online tools to manage their care including a personal health record. Our primary hypothesis is that use of Healthy.me for patients with asthma will increase possession and uptake of a written asthma action plan. This randomized controlled trial will also specifically test whether system use is associated with the following secondary outcome measures: i) significant improvement in asthma control, ii) increased compliance according to written asthma action plan, iii) reduced unplanned utilization of health services, iv) reduced frequency of exacerbations, and iv) improved quality of life over 12 months. Patients and consumers are increasingly using online systems to make health decisions and manage their health but we still know little about their patterns of use and impact. This study will make a specific and significant contribution to our understanding of the effectiveness of online systems for patients and healthcare consumers.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Annie Lau

Address

Centre for health Informatics Level 1 AGSM Building (G27) University of New South Wales SYDNEY NSW 2052

Country

Australia

Phone

+61 02938 58891

Fax

a.lau@unsw.edu.au

Contact person for public queries

Name

Amael Arguel

Address

Centre for health Informatics
Level 1 AGSM Building (G27)
University of New South Wales
SYDNEY NSW 2052

Country

Australia

Phone

+61 02938 58691

Fax

a.arguel@unsw.edu.au

Contact person for scientific queries

Name

Annie Lau

Address

Centre for health Informatics
Level 1 AGSM Building (G27)
University of New South Wales
SYDNEY NSW 2052

Country

Australia

Phone

+61 02938 58891

Fax

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

Source	Title	Year of Publication	DOI
Embase	"Why Didn't it Work?" Lessons From a Randomized Controlled Trial of a Web-based Personally Controlled Health Management System for Adults with Asthma.	2015	https://dx.doi.org/10.2196/jmir.4734

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