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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00220974
Registration number
NCT00220974
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
13/02/2009
Titles & IDs
Public title
Study to Assess if Internet-Based Tailored Advice Could Modify Behaviour to Improve Health
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Scientific title
Internet-Based Cholesterol Assessment Trial
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Secondary ID [1]
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I-CAT
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Secondary ID [2]
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I-CAT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Internet-based tailored advice on cardiovascular risk
Behaviour: Internet-based tailored advice on cardiovascular risk
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To determine the effectiveness of a consumer-mediated, Internet-based strategy for identification and intervention in hypercholesterolemia.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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To determine the effectiveness of a consumer-mediated, Internet-based strategy in the adoption of healhier behaviour and lifestyle
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
The eligibility criteria for index cases will be:
- Internet access
- Informed consent
- Resident in Australia
- Prepared to answer some simple baseline questions about health
- Prepared to return to the site on up to two occasions over the following 8-16 weeks to
answer some brief follow-up questions, and
- Not referred to the site by a friend of a relative already enrolled in the study
(since they would then be a 'friend or relative' - see below).
A friend or relative of the index cases will be required to fulfil the same eligibility
criteria except that they:
- Will be provided with a modified information sheet and consent form congruent with
their level of participation in the study
- Will have been referred to the service by an index case, and
- Will only be required to visit the site on one more occasion (after 8 weeks) to answer
some brief follow-up questions.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Individual who is not residing in Australia
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Study design
Purpose of the study
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2006
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Sample size
Target
3708
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The George Institute for International Health - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Lipid and Cardiovascular Risk Assessment Service, ICPMR, Westmead Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Royal Prince Alfred Hospital, Sydney, Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/Industry
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Name [3]
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Pfizer
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Medical benefit Fund (MBF)
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to find out if a special website might help people discover if
they have high cholesterol and then enable them to manage their cholesterol more
appropriately. The primary aim of this trial is to determine the effects on consumers' use of
cholesterol lowering therapy of an online service that provides automated, individually
tailored, advice about eligibility for cholesterol lowering treatment. The primary null
hypothesis being tested is that the service will result in no change in the use of
cholesterol lowering treatments by consumers that use the service.
The secondary aim of the trial is to see if it is possible to improve the cholesterol
management of the friends or relatives of consumers that use the I-CAT service. The
corresponding secondary null hypothesis being tested is that the I-CAT service will result in
no change in the use of cholesterol lowering treatments by the friends or relatives of the
consumers that use the service.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00220974
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bruce Neal, MB BS PhD
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Address
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The George Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00220974
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