Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk FactorsPhase 1ICATNCT01890031

Interactive Cholesterol Advisory Tool

A Phase 1 study testing Interactive Cholesterol Advisory Tool and Study physician visits in people with Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors and Moderate Risk (10-20% Chance) of Developing Cardiovascular (Heart) Disease Within 10 Years Based on Risk Factors, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to show that we can effectively deliver health information and education, online, via computer regarding cholesterol. This computer program is called the Interactive Cholesterol Advisory Tool (ICAT). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors, Moderate Risk (10-20% Chance) of Developing Cardiovascular (Heart) Disease Within 10 Years Based on Risk Factors
What is being tested?: Interactive Cholesterol Advisory Tool and Study physician visits
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Jun 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Fluency in English,
Willing to come in for 1-5 visits,
Low and moderate CVD risk.
Having access to a computer with internet connection

Who cannot join

CVD diagnosis or CVD equivalent,
Psychosis, terminal illness,
Pregnancy,
Current statin use if assigned to the low risk group
Liver disease,
Peripheral Vascular Disease,

Show all 11Show fewer

Diabetes Mellitus,
Abdominal Aortic Aneurism,
Cerebral Vascular Disease
Triglyceride level above 500 mg/dl
Uncorrected hypothyroidism

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester
Rochester, New York, 14607

Other trials in United States

About this study

Official title: The Interactive Cholesterol Advisory Tool

Read the detailed description

Participants will be recruited and categorized based on screening labs into 1 of 2 groups: Low or moderate risk of developing cardiovascular disease within 10 years based on risk factors. The low risk group will be advised to take the blood test results furnished by the study to their primary care doctor to discuss managing cholesterol. The moderate risk group will see the study physician for 4 visits about high cholesterol. Both groups complete a total of 4 blood draws over 9 months. Both groups will be randomized at consent into 2 groups: 1 who uses the Interactive Cholesterol Advisory Tool (ICAT) and 1 that does not use the ICAT. Because recruitment goals for the low risk group were met, a third group was created: low risk who both the study physician for 4 visits about high cholesterol and use the ICAT.

Conditions: Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors, Moderate Risk (10-20% Chance) of Developing Cardiovascular (Heart) Disease Within 10 Years Based on Risk Factors
Being tested: Interactive Cholesterol Advisory Tool, Study physician visits
Keywords: cardiovascular disease, cholesterol
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interactive Cholesterol Advisory ToolOther
using the virtual clinician computer program for cholesterol information and education.
Study physician visitsOther
In-person individual visits with a study physician to give information on cholesterol

Study groups in NCT01890031
Study group	Role	What they receive
Low Risk, No ICAT	No intervention	Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Low risk, ICAT	Other	Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits Receives: Other: Interactive Cholesterol Advisory Tool
Low risk, ICAT, and study physician	Other	Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits. Receives: Other: Interactive Cholesterol Advisory Tool; Other: Study physician visits
Moderate risk, no ICAT	Other	Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool Receives: Other: Study physician visits
Moderate risk, ICAT	Other	Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool Receives: Other: Interactive Cholesterol Advisory Tool; Other: Study physician visits

What is being measured

The primary outcome is the main question the study is designed to answer.

LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants
Measured: 9 months

Secondary outcomes (1)

Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months
We will assess adherence (for those who are prescribed a statin in the moderate CVD risk group) by both indirect objective measures and subjective reports. The study design did not include prescription of a cholesterol-lowering medication as per randomization. Participants were prescribed a statin as standard of care based on the participants and physicians agreement. Low risk individuals have less need for medication compared to moderate risk based on the current science.
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2013

First posted1 Jul 2013 (estimated)
Study startJan 2012
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk FactorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01890031
Sponsor's protocol ID: 1R44HL097506-01
Acronym: ICAT
Status last verified: Aug 2015
First submitted: 18 Jun 2012
Last updated: 4 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Block RC, Abdolahi A, Niemiec CP, Rigby CS, Williams GC. Effects of an evidence-based computerized virtual clinician on low-density lipoprotein and non-high-density lipoprotein cholesterol in adults without cardiovascular disease: The Interactive Cholesterol Advisory Tool. Health Informatics J. 2016 Dec;22(4):897-910. doi: 10.1177/1460458215600040. Epub 2015 Aug 21.
PubMed 26297222

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Interactive Cholesterol Advisory Tool
ClinicalTrials.gov ID: NCT01890031
Acronym / sponsor ID: ICAT / 1R44HL097506-01
Conditions: Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors, Moderate Risk (10-20% Chance) of Developing Cardiovascular (Heart) Disease Within 10 Years Based on Risk Factors
Keywords: cardiovascular disease, cholesterol
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: Jan 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 1 Jul 2013 (estimated)
Results: Posted 4 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Low Risk, No ICAT	No intervention	–Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Low risk, ICAT	Other	Other: Interactive Cholesterol Advisory ToolLow risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
Low risk, ICAT, and study physician	Other	Other: Interactive Cholesterol Advisory Tool, Other: Study physician visitsLow risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits.
Moderate risk, no ICAT	Other	Other: Study physician visitsModerate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool
Moderate risk, ICAT	Other	Other: Interactive Cholesterol Advisory Tool, Other: Study physician visitsModerate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Fluency in English,
Willing to come in for 1-5 visits,
Low and moderate CVD risk.
Having access to a computer with internet connection

Key exclusion criteria (11 listed)

CVD diagnosis or CVD equivalent,
Psychosis, terminal illness,
Pregnancy,
Current statin use if assigned to the low risk group
Liver disease,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interactive Cholesterol Advisory Toolusing the virtual clinician computer program for cholesterol information and education.	Other	Low risk, ICAT, Low risk, ICAT, and study physician, Moderate risk, ICAT
Study physician visitsIn-person individual visits with a study physician to give information on cholesterol	Other	Low risk, ICAT, and study physician, Moderate risk, ICAT, Moderate risk, no ICAT

Primary outcome

LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants
Time frame: 9 months

1 secondary outcome

Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months
Time frame: 9 months

Results and safety

Results posted to the registry on 4 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Risk, No ICAT	50	50
Low Risk, ICAT	50	50
Moderate Risk, no ICAT	12	12
Moderate Risk, ICAT	11	11
Low Risk, ICAT, and Study Physician	8	8

Primary outcome: LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants

Time frame: 9 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Low Risk, No ICAT n = 50	Low Risk, ICAT n = 50	Moderate Risk, no ICAT n = 12	Moderate Risk, ICAT n = 11	Low Risk, ICAT, and Study Physician n = 8
Value	126.2 (32.3)	126.0 (28.8)	103.2 (35.1)	107.7 (32.3)	107.0 (45.7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data were collected at over 9 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Risk, No ICAT	0 of 50 (0%)	0 of 50 (0%)	Not reported
Low Risk, ICAT	0 of 50 (0%)	0 of 50 (0%)	Not reported
Moderate Risk, no ICAT	0 of 12 (0%)	0 of 12 (0%)	Not reported
Moderate Risk, ICAT	0 of 11 (0%)	0 of 11 (0%)	Not reported
Low Risk, ICAT, and Study Physician	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26297222Block RC, Abdolahi A, Niemiec CP, Rigby CS, Williams GC. Effects of an evidence-based computerized virtual clinician on low-density lipoprotein and non-high-density lipoprotein cholesterol in adults without cardiovascular disease: The Interactive Cholesterol Advisory Tool. Health Informatics J. 2016 Dec;22(4):897-910. doi: 10.1177/1460458215600040. Epub 2015 Aug 21.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Block, MD, MPH principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01890031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.