Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Telemedicine in Cardiac Surgery: A Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01163474
First received: July 14, 2010
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Coronary Artery Disease
Intervention: Other: Evaluate video clinic visit prior to Face-to-Face usual care visit

  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
Patients were recruited after coronary artery bypass or cardiac valvular surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants were assigned to both the intervention (post-surgical evaluation by video-teleconference) and control (face-to-face visit) groups.

Reporting Groups
  Description
Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua Evaluate video clinic visit prior to Face-to-Face usual care visit

Participant Flow:   Overall Study
    Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua  
STARTED     40  
COMPLETED     24  
NOT COMPLETED     16  
Withdrawal by Subject                 1  
Tech barriers to videoteleconference vis                 12  
Lost to Follow-up                 3  



  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
Arm 1 - Evaluate Video Clinic Visit Evaluate video clinic visit prior to Face-to-Face usual care visit

Baseline Measures
    Arm 1 - Evaluate Video Clinic Visit  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 8.3  
Gender  
[units: participants]
 
Female     0  
Male     24  
Race/Ethnicity, Customized  
[units: participants]
 
White     16  
African American     4  
Hispanic     4  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures
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1.  Primary:   Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)   [ Time Frame: 1 month ]

2.  Secondary:   Acceptability   [ Time Frame: 1 month ]

3.  Secondary:   Feasibility   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Donna Smith/Project Coordinator
Organization: Houston VA HSR&D
phone: (713)440-4423
e-mail: Donna.Smithd19d7@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01163474     History of Changes
Other Study ID Numbers: PPO 10-060
Study First Received: July 14, 2010
Results First Received: December 9, 2014
Last Updated: December 18, 2014
Health Authority: United States: Federal Government