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Decision Aid to Technologically Enhance Shared Decision Making (DATES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masahito Jimbo, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01514786
First received: January 17, 2012
Last updated: September 10, 2017
Last verified: September 2017
Results First Received: March 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition: Colorectal Cancer
Intervention: Behavioral: Colorectal Web

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
Intervention With Colorectal Website

Intervention website includes an interactive component including preferences and risk assessment.

Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS


Participant Flow:   Overall Study
    Control   Intervention With Colorectal Website
STARTED   286   284 
COMPLETED   286   284 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
Intervention With Colorectal Website

Intervention website includes an interactive component including preferences and risk assessment.

Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS

Total Total of all reporting groups

Baseline Measures
   Control   Intervention With Colorectal Website   Total 
Overall Participants Analyzed 
[Units: Participants]
 286   284   570 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      231  80.8%      240  84.5%      471  82.6% 
>=65 years      55  19.2%      44  15.5%      99  17.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (6.9)   57.1  (6.8)   57.7  (6.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      177  61.9%      143  50.4%      320  56.1% 
Male      109  38.1%      141  49.6%      250  43.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   286   284   570 
Participants screened for colon cancer 
[Units: Participants]
Count of Participants
 111   99   210 


  Outcome Measures

1.  Primary:   Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits   [ Time Frame: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Masahito Jimbo
Organization: UMichigan
phone: 734-998-7120
e-mail: mjimbo@med.umich.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Masahito Jimbo, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01514786     History of Changes
Other Study ID Numbers: HUM00044733
Study First Received: January 17, 2012
Results First Received: March 14, 2017
Last Updated: September 10, 2017