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Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01296841
First received: February 15, 2011
Last updated: February 6, 2013
Last verified: February 2013
Results First Received: January 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Intervention: Device: Collaborative Imaging

  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
Standard Encounter Standard "in-house" clinical visit between patient and physician.
Telemedicine Encounter Remote clinical appointment between patient and physician.

Participant Flow:   Overall Study
    Standard Encounter     Telemedicine Encounter  
STARTED     19     15  
COMPLETED     19     15  
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.
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Reporting Groups
  Description
Standard Encounter Standard "in-house" clinical visit between patient and physician.
Telemedicine Encounter Remote clinical appointment between patient and physician.
Total Total of all reporting groups

Baseline Measures
    Standard Encounter     Telemedicine Encounter     Total  
Number of Participants  
[units: participants]
  19     15     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     9     24  
>=65 years     4     6     10  
Age  
[units: years]
Mean ± Standard Deviation
  58.5  ± 9.6     62.8  ± 11.5     60.4  ± 10.5  
Gender  
[units: participants]
     
Female     6     2     8  
Male     13     13     26  
Region of Enrollment  
[units: participants]
     
United States     19     15     34  



  Outcome Measures
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1.  Primary:   Patient Clinical Experience   [ Time Frame: Clinic Visit ]

2.  Secondary:   Clinic Appointment Duration   [ Time Frame: Clinic Visit ]

3.  Secondary:   Clinic Appointment Wait Time   [ Time Frame: Clinic Visit ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Roy Soetikno, Chief of Endoscopy, Principal Investigator
Organization: VA Palo Alto
phone: 650-493-5000 ext 64800
e-mail: roy.soetikno@va.gov


Publications:


Responsible Party: Roy Soetikno, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01296841     History of Changes
Other Study ID Numbers: TELEMED PA
Study First Received: February 15, 2011
Results First Received: January 15, 2012
Last Updated: February 6, 2013
Health Authority: United States: Federal Government