NCT00220974

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,708

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

February 11, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individual who is not residing in Australia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Institute for International Health

Camperdown, New South Wales, 2050, Australia

Location

Related Publications (1)

  • Webster R, Li SCh, Sullivan DR, Jayne K, Su SY, Neal B. Effects of internet-based tailored advice on the use of cholesterol-lowering interventions: a randomized controlled trial. J Med Internet Res. 2010 Sep 13;12(3):e42. doi: 10.2196/jmir.1364.

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bruce Neal, MB BS PhD

    The George Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations