Trial Review

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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
Scientific title
Internet-Based Cholesterol Assessment Trial
Secondary ID [1] 0 0
I-CAT
Secondary ID [2] 0 0
I-CAT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Internet-based tailored advice on cardiovascular risk

Behaviour: Internet-based tailored advice on cardiovascular risk
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the effectiveness of a consumer-mediated, Internet-based strategy for identification and intervention in hypercholesterolemia.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To determine the effectiveness of a consumer-mediated, Internet-based strategy in the adoption of healhier behaviour and lifestyle
Timepoint [1] 0 0

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individual who is not residing in Australia

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
3708
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for International Health - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lipid and Cardiovascular Risk Assessment Service, ICPMR, Westmead Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Pfizer
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Medical benefit Fund (MBF)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00220974
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce Neal, MB BS PhD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries