NCT01315288

Brief Summary

The purpose of this study is to determine patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis. The hypothesis is that information variables are the most significant determinant of clinical decision making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
409

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

March 14, 2011

Last Update Submit

January 2, 2024

Conditions

Carotid Stenosis

Keywords

Medical decision makingAsymptomatic Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

  • Decision regarding surgery

    Subjects are asked to make a choice regarding surgery after watching a 30 second video.

    Approximately 2 minutes

Study Arms (5)

Video presentation absolute risk

ACTIVE COMPARATOR

absolute risk

Other: One of 6 video presentation by one of 4 presenters

Video presentation absolute event-free survival

ACTIVE COMPARATOR

absolute event-free survival

Other: One of 6 video presentation by one of 4 presenters

Video presentation annualized absolute risk

ACTIVE COMPARATOR

annualized absolute risk

Other: One of 6 video presentation by one of 4 presenters

Video presentation relative risk

ACTIVE COMPARATOR

relative risk

Other: One of 6 video presentation by one of 4 presenters

Video presentation qualitative description

ACTIVE COMPARATOR

qualitative description

Other: One of 6 video presentation by one of 4 presenters

Interventions

One of 6 video presentation by one of 4 presentersOTHER
Video presentation absolute event-free survivalVideo presentation absolute riskVideo presentation annualized absolute riskVideo presentation qualitative descriptionVideo presentation relative risk

Eligibility Criteria

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

You may qualify if:

  • No known history of carotid stenosis

You may not qualify if:

  • History of dementia
  • Unable to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

August 1, 2010

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

US(1)