NCT01296841

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

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, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 7, 2013

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

February 15, 2011

Results QC Date

January 15, 2012

Last Update Submit

January 17, 2017

Conditions

Keywords

telemedicineremote consultationtelehealthehealthimage archivinginflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • Patient Clinical Experience

    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.

    Clinic Visit

Secondary Outcomes (2)

  • Clinic Appointment Duration

    Clinic Visit

  • Clinic Appointment Wait Time

    Clinic Visit

Study Arms (2)

Standard encounter

NO INTERVENTION

Standard "in-house" clinical visit between patient and physician.

Telemedicine Encounter

EXPERIMENTAL

Remote clinical appointment between patient and physician.

Device: Collaborative Imaging

Interventions

Hardware and software communication tools to provide clinical care from a distance.

Also known as: Telemedicine
Telemedicine Encounter

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • VA patients without IBD
  • Hospitalized IBD patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Palo Alto

Palo Alto, California, 94304, United States

Location

Related Publications (7)

  • Telleman H, Burger TF, Mulder CJ. Evolution of gastroenterology training. World J Gastroenterol. 2009 Apr 21;15(15):1793-8. doi: 10.3748/wjg.15.1793.

    PMID: 19370773BACKGROUND
  • Fisher ES, Welch HG. The future of the Department of Veterans Affairs health care system. JAMA. 1995 Feb 22;273(8):651-5. No abstract available.

    PMID: 7844876BACKGROUND
  • Dorsey ER, Deuel LM, Voss TS, Finnigan K, George BP, Eason S, Miller D, Reminick JI, Appler A, Polanowicz J, Viti L, Smith S, Joseph A, Biglan KM. Increasing access to specialty care: a pilot, randomized controlled trial of telemedicine for Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1652-9. doi: 10.1002/mds.23145.

    PMID: 20533449BACKGROUND
  • Verhoeven F, Tanja-Dijkstra K, Nijland N, Eysenbach G, van Gemert-Pijnen L. Asynchronous and synchronous teleconsultation for diabetes care: a systematic literature review. J Diabetes Sci Technol. 2010 May 1;4(3):666-84. doi: 10.1177/193229681000400323.

    PMID: 20513335BACKGROUND
  • Grogan-Johnson S, Alvares R, Rowan L, Creaghead N. A pilot study comparing the effectiveness of speech language therapy provided by telemedicine with conventional on-site therapy. J Telemed Telecare. 2010;16(3):134-9. doi: 10.1258/jtt.2009.090608. Epub 2010 Mar 2.

    PMID: 20197354BACKGROUND
  • van der Heijden JP, Spuls PI, Voorbraak FP, de Keizer NF, Witkamp L, Bos JD. Tertiary teledermatology: a systematic review. Telemed J E Health. 2010 Jan-Feb;16(1):56-62. doi: 10.1089/tmj.2009.0020.

    PMID: 20064068BACKGROUND
  • Wallace P, Haines A, Harrison R, Barber JA, Thompson S, Roberts J, Jacklin PB, Lewis L, Wainwright P; Virtual Outreach Project Group. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250]. BMC Fam Pract. 2002 Jan 11;3:1. doi: 10.1186/1471-2296-3-1. Epub 2002 Jan 11.

    PMID: 11835692BACKGROUND

Related Links

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Results Point of Contact

Title
Roy Soetikno
Organization
VA Palo Alto

Study Officials

  • Tonya Kaltenbach, MD MS

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Chief of Endoscopy

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 16, 2011

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 3, 2017

Results First Posted

February 7, 2013

Record last verified: 2017-01

Locations