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T-16: Patients With Gastrointestinal Disorders Prefer Electronic and Interactive Training When Participating in a Clinical Trial

Poster Presenter

Nadeeka Dias

Sr. Scientific Advisor
ERT
United States

Objectives

Patient-reported outcomes (PROs) collected as endpoints in gastrointestinal clinical trials often require patients to report details on symptoms and impact on quality of life. The need for training on these items was examined along with preferences on how patients would prefer to receive training.

Method

Individuals (n=86) diagnosed Gastroesophageal Reflux Disease, Ulcerative Colitis, and/or Irritable Bowel Syndrome were asked to report their opinions on the need for training, the preferred format of training, and importance of accessibility to training. Demographic data were also collected.

Results

Among the total participants, 82 people responded to this question. Participants were asked “If you were participating in a clinical trial, do you think it would help to be provided educational materials and training on your role in it, what to expect and the purpose of the clinical trial”. 96.3% considered educational materials and training “definitely needed” (80.5%) or “somewhat needed” (15.9%). Participants were asked “If you were participating in a clinical trial and educational information and training was provided to you on your role and what to expect in a clinical trial, which format would you most prefer to take the training”. 98.8% reported that they would be interested in some form of training. Specifically, 70.7% prefer interactive training videos provided on mobile electronic devices or the internet. Participants were asked “If you were participating in a clinical trial and educational information and training was provided to you about your role and what to expect in a clinical trial, is it important to you to have access to this training at any time during the trial, so you could refresh on it”. 90.2% of patients considered it to be “definitely necessary” (60.1%) or “somewhat necessary” (29.3%) to be able to access and refresh training at any time during the trial.

Conclusion

These findings suggest that the majority of responders with gastrointestinal disorders consider training materials on PROs as a highly requisite and necessary step for clinical trial participation. Further, most responders prefer electronic means of training, as well as the ability to readily refresh on training materials. Such a mechanism can be addressed in the form of interactive training videos on the trial device, such as an electronic clinical outcome assessment (eCOA) handheld or tablet device, where such materials can be accessed offline at any time. These patient preferences are also in line with regulatory guidance for this therapeutic area which states “Patients should be trained on the completion of the event log or diary. The instructions for completion of the stool frequency and rectal bleeding assessments should be incorporated into the event log or diary for ready reference by the patient”. Therefore, custom electronic training including specific guidance on how to capture rectal bleeding and stool frequency as well as understanding of trial expectation would be highly beneficial in improving clinical trial data quality while complying with the FDA’s recommendations.