Telemedicine Acceptance in IBD

Protocol Builder Input Period Has Closed. Thank You for Participating.

 

Why study telemedicine acceptance in IBD?

Transparency Life Sciences, in collaboration with Genentech, a member of the Roche Group, is conducting a pilot study in patients with inflammatory bowel disease.

  • The primary objective of this pilot study is to evaluate the effectiveness and ease-of-use of telemonitoring technology and techniques in assessing standard clinical endpoints in IBD.

  • We are focused on new methods to include patients’ local gastroenterologists in the development and execution of a clinical trial.

  • We are also investigating the role of dietary intervention in a trial in IBD.

  • We are interested in learning which symptoms are most important to IBD patients, and how they think those symptoms can be monitored at home.

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An Opportunity for Publication

This project's Protocol Builder was completed before the implementation of the TLS Reward System. Therefore no rewards have been given for this project.

Protocol Builder Results

Primary Objective

Here's what TLS users are saying:

  • Telemedicine started to revolutionize clinical research, so it is very timely to apply to IBD.
  • It is very interesting to have potentially more real time data and even a researcher database.
  • I think that virtual modality tools are underutilized, and have the potential to allow efficacy trials to translate to effectiveness research.
Here you will have a chance to comment on the overall goals of the project.

By describing their most meaningful symptoms, patients are helping us tailor the study to collect data on the aspects of IBD that are most pertinent to them.

Do you agree with the general reasoning behind using telemedicine techniques and devices in a study of IBD?

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Population

We've found that all researchers agree that prior participation in a clinical trial does affect a patient's ability to participate in a trial that focuses on telemedicine use and acceptance.

Which population should be studied?

We are asking for basic demographic information in this section.

What disease groups do you believe should be studied?

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Choice of Primary Endpoint

Which primary endpoints are amenable to remote assessment?

How can an endpoint in IBD be remotely assessed?

What aspects of the Mayo Score can be assessed remotely?

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Choice of Secondary Endpoints

What other aspects of IBD can be included in a study?

What is your experience with dietary intervention?

How else can the Mayo Score be assessed in different populations?

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Telemedicine

Some telemedicine solutions that patients and researchers have recommended are:

  • Symptom tracking smartphone apps
  • Stool sample photography
  • Video conference links between patients and trial staff
We are asking all respondents to react to multiple ways of remotely assessing a study in IBD.

What experience do you have with telemedicine, and how do you envision IBD symptoms being assessed remotely?

Do you have prior experience using telemedicine, and what are your ideas for remote assessment?

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Local GI Participation

  • Patients and medical professionals have both expressed a desire to use electronic communication to conduct aspects of the trial.
  • Many patients have stressed the possibility of email and video technology providing greater access to physicians.
  • Clinicians have stressed how the same email and video technology can help make communicating with patients easier and more amenable to a doctor's schedule.
How can we conduct a trial with greater involvement from patients' gastroenterologists?

How involved and informed would you like your local GI to be in a study?

How can we keep local GIs and trial staff working together to execute a better trial?

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Regulatory

What regulatory concerns do you have?

What are your thoughts on the regulatory process?

How does the use of telemedicine alter the regulatory environment?

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Genotyping

Should genotyping be used in a study in IBD?

What are your thoughts in genotyping in clinical trials?

Are there any specific genetic variations that should accounted for in this trial?

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Safety

  • Patients and researchers both believe that telemedicine can increase the safety of an IBD clinical trial.
  • Most clinicians are confident in recommending a remote trial of telemedicine in IBD to their patients.
What safety concerns do you have?

What safety concerns do you have using remote monitoring or metformin itself?

How can we best implement telemonitoring to provide the best data in the safest manner?

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Visits/Monitoring

We have not come to a consensus on the study's monitoring plan. Please share your ideas.

What are your ideas for a monitoring plan in this pilot and other IBD studies?

Patients are not being asked to respond to a monitoring plan question at this time.

Please share any thoughts you may have.

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Data Visualization

Here are some researchers' responses:

  • Use a web-based data platform that allows entry of data from all involved in the trial
  • Password protected portal availability to researchers and patients alike

     

Please help us create a data visualization plan.

Please discuss the data visualization plan in the forum by clinking the "Comments" button below.

We aim at making real life data available for all to see and understand. The only exceptions will be individual identification of patients and data which may lead to un­blinding of the study, if applicable.

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