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

February 11, 2009 updated by: The George Institute

Internet-Based Cholesterol Assessment Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

There will be two types of individuals involved in the study: 'index cases' and 'friends or relatives' of the index cases. The index cases will be randomised to intervention or control and will comprise the study participants on which the main outcome analyses will be based. Friends and relatives of the index case will only be involved insomuch as they will be asked to visit the site by the index case as part of the evaluation of the effectiveness of the intervention.

Index cases will comprise mainly individuals already known to be at high risk of a cholesterol-related disease event - for example individuals with established vascular disease, individuals with multiple risk factors and individuals already using cholesterol-lowering therapy. Index cases will be recruited using advertising materials placed at a range of sites including hospital in patient services, hospital out patient services, general practices, pharmacies, pathology services and the Internet.

All individuals that provide informed consent (index cases and friends or relatives) will be asked to answer as many questions as possible from the XX questions in the baseline questionnaire. The questionnaire will seek information about the individual's cardiovascular disease history, their risk factors, their cholesterol levels, their use of any medications or other strategies to reduce their cholesterol-related cardiovascular risk and any family history of cardiovascular disease or high cholesterol levels.

Once baseline data collection is complete index cases will be randomised to either intervention or control. Randomisation will be done automatically in real time by a central computerised service. The intervention group will receive immediate feedback from the I-CAT service. The control group will receive general information about cholesterol-related disease risk derived from existing materials prepared by the National Heart Foundation of Australia. Hyperlinks to a range of relevant websites will be provided.

In addition, after returning to the website at 8 weeks and providing follow-up information, all control group participants will receive the same tailored feedback from the I-CAT service as was given to the intervention group participants at randomisation. In this way, all study participants will ultimately receive the same advice but by providing one group with immediate advice and one group with delayed advice it will be possible to precisely and reliably determine the value of the I-CAT service to consumers.

All primary analyses will be of comparisons between the index cases in the intervention group and the index cases in the control group conducted according to the principle of intention-to-treat. For each outcome the analyses will compare the proportions of index cases reporting the outcome (or the mean values for each outcome) between randomised groups. Comparisons of proportions will be done using Chi-square tests and comparisons between means will be done using t-tests.

Study Type

Interventional

Enrollment (Anticipated)

3708

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

• Individual who is not residing in Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute

Collaborators

Pfizer
Royal Prince Alfred Hospital, Sydney, Australia
Lipid and Cardiovascular Risk Assessment Service, ICPMR, Westmead Hospital
Medical benefit Fund (MBF)

Investigators

  • Principal Investigator: Bruce Neal, MB BS PhD, The George Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-CAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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