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Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care

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ClinicalTrials.gov Identifier: NCT01296841
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : February 7, 2013
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System

Brief Summary:
The investigators hypothesize that outpatient clinical care of Inflammatory Bowel Disease patients may be provided using a new computerized system over standard network - called Collaborative Imaging - with similar patient experience compared to a conventional clinic visit.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease Device: Collaborative Imaging Phase 2

Detailed Description:

Significant advances in gastroenterology have led the field to grow into a number of advanced subspecialties: inflammatory bowel disease (IBD), motility, therapeutic endoscopy, and transplant hepatology. Telemedicine, the application of information technology in support of health care delivery from a distance, has been employed with good success in various chronic conditions with excellent patient satisfaction.

Primary Aim: Our primary study endpoint was measuring patient clinical experience between two groups: A telemedicine remote clinic visit and a standard "in-house" visit.

Secondary Aim: To compare standard clinic metrics including clinic wait time, patient throughput, and appointment time between the two groups.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Pilot: Use of Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
Study Start Date : October 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Standard encounter
Standard "in-house" clinical visit between patient and physician.
Experimental: Telemedicine Encounter
Remote clinical appointment between patient and physician.
Device: Collaborative Imaging
Hardware and software communication tools to provide clinical care from a distance.
Other Name: Telemedicine

Primary Outcome Measures :
  1. Patient Clinical Experience [ Time Frame: Clinic Visit ]
    We used a validated Ware Specific Visit Questionnaire to assess patients' satisfaction with their clinic-visit encounter. This is a 14-item questionnaire on doctor-patient interaction including factors such as attention to complaints, technical skills, and personal manner (courtesy,and ease of appointment scheduling and is based on a five-point Likert scale (1 excellent to 5 poor). Patients completed the questionnaire at the time of the visit. The 14 item scores were individually scored and then averaged to provide the final overall value.

Secondary Outcome Measures :
  1. Clinic Appointment Duration [ Time Frame: Clinic Visit ]
    The investigators recorded appointment duration in minutes.

  2. Clinic Appointment Wait Time [ Time Frame: Clinic Visit ]
    The investigators recorded clinic appointment wait time duration in minutes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult (> 18 years old) outpatient IBD patients in the Veterans Affairs medical system

Exclusion Criteria:

  • VA patients without IBD
  • Hospitalized IBD patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296841

United States, California
Veterans Affairs Palo Alto
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Principal Investigator: Tonya Kaltenbach, MD MS VA Palo Alto Health Care System

Additional Information:

Responsible Party: Roy Soetikno, Clinical Professor, Chief of Endoscopy, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01296841     History of Changes
Other Study ID Numbers: TELEMED PA
First Posted: February 16, 2011    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: March 3, 2017
Last Verified: January 2017

Keywords provided by Roy Soetikno, VA Palo Alto Health Care System:
remote consultation
image archiving
inflammatory bowel disease

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases