Inflammatory Bowel DiseasePhase 2NCT01296841
Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
A Phase 2 study testing Collaborative Imaging in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by VA Palo Alto Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Collaborative Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 years old) outpatient IBD patients in the Veterans Affairs medical system
Who cannot join
- VA patients without IBD
- Hospitalized IBD patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Palo Alto
Palo Alto, California, 94304
About this study
Official title: A Randomized Controlled Pilot: Use of Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
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.
Read the 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.
- Being tested
- Collaborative Imaging
- Keywords
- telemedicine, remote consultation, telehealth, ehealth, image archiving, inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative ImagingDevice
Also called Telemedicine
Hardware and software communication tools to provide clinical care from a distance.
| Study group | Role | What they receive |
|---|---|---|
| Standard encounter | No intervention | Standard "in-house" clinical visit between patient and physician. |
| Telemedicine Encounter | Experimental | Remote clinical appointment between patient and physician. Receives: Device: Collaborative Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Clinic Visit
Secondary outcomes (2)
Clinic Appointment Duration
The investigators recorded appointment duration in minutes.
Measured: Clinic Visit
Clinic Appointment Wait Time
The investigators recorded clinic appointment wait time duration in minutes
Measured: Clinic Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Roy Soetikno, VA Palo Alto Health Care System
- Investigators
- Tonya Kaltenbach, MD MS, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296841
- Sponsor's protocol ID
- TELEMED PA
- Status last verified
- Jan 2017
- First submitted
- 15 Feb 2011
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19370773Fisher 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.
PubMed 7844876Dorsey 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.
PubMed 20533449Verhoeven 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.
PubMed 20513335Grogan-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.
PubMed 20197354van 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.
PubMed 20064068Wallace 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.
PubMed 11835692
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot: Use of Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
- ClinicalTrials.gov ID
- NCT01296841
- Acronym / sponsor ID
- TELEMED PA
- Keywords
- telemedicine, remote consultation, telehealth, ehealth, image archiving, inflammatory bowel disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 7 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard encounter | No intervention | –Standard "in-house" clinical visit between patient and physician. |
| Telemedicine Encounter | Experimental | Device: Collaborative ImagingRemote clinical appointment between patient and physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (> 18 years old) outpatient IBD patients in the Veterans Affairs medical system
Key exclusion criteria (2 listed)
- VA patients without IBD
- Hospitalized IBD patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative ImagingAlso: TelemedicineHardware and software communication tools to provide clinical care from a distance. | Device | Telemedicine Encounter |
Primary outcome
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.
2 secondary outcomes
Clinic Appointment Duration
Time frame: Clinic Visit
Clinic Appointment Wait Time
Time frame: Clinic Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19370773Telleman 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.
- Background: PubMed 7844876Fisher 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.
- Background: PubMed 20533449Dorsey 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.
- Background: PubMed 20513335Verhoeven 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.
- Background: PubMed 20197354Grogan-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.
- Background: PubMed 20064068van 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.
- Background: PubMed 11835692Wallace 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.
- telemedicine personal computerLink provided by the sponsor.
- telemedicine personal computerLink provided by the sponsor.
- telemedicine headsetLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonya Kaltenbach, MD MS principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collaborative Imaging in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by VA Palo Alto Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Clinical Experience (time frame: Clinic Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296841, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.