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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
NA
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00220974