Study to Assess If Internet-Based Tailored Advice Could Modify Behaviour to Improve Health

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.

Official Title

Internet-Based Cholesterol Assessment Trial

Conditions

Hypercholesterolemia

Study Type

Interventional

Study Design

Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• To determine the effectiveness of a consumer-mediated, Internet-based strategy for identification and intervention in hypercholesterolemia.

Secondary Outcome Measures:

• To determine the effectiveness of a consumer-mediated, Internet-based strategy in the adoption of healhier behaviour and lifestyle

The Internet-based Cholesterol Assessment Trial (I-CAT) is a masked, randomised, controlled trial that will include at least 3,700 consumers followed for between 8 and 16 weeks. All consumers that participate in the study will ultimately be offered the I-CAT service, which provides individually tailored information about the management of cholesterol-related risk via an interactive website. However, by offering the service immediately to one group (intervention) and delaying it by 8 weeks in the other group (control) it will be possible to precisely and reliably determine the effects of the I-CAT service on consumers and their use of cholesterol lowering interventions.

Study Start

October 2004; Expected completion: September 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• 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.

Total Enrolment

3708

Contact Details

• Ruth Webster, MB BS: 61 2 9993 4500; rwebster@thegeorgeinstitute.org
• Stephen Li, MB BS FRCPA: 61 2 9845 7990; stephenl@icpmr.wsahs.nsw.gov.au

The George Institute for International Health, Camperdown, New South Wales, 2050, Australia; Recruiting

• Merianos Helen: 61 2 9993 4500; hmerianos@thegeorgeinstitute.org
• Bruce Neal, MB BS PhD: 61 2 9993 4500; bneal@thegeorgeinstitute.org

I-CAT website