Tubestop - Create Patient-facing Materials

Description

Patient-facing materials are any documents or communications that are provided to patients who are considering trial participation or who are participating in a clinical trial. These materials should be clear, concise, and easy to understand. They should provide patients and their families / caregivers with the information needed to make an informed decision about whether or not to participate in the trial. Some common types of patient-facing materials include:

Informed consent form: This is the most important patient-facing material. It provides patients with detailed information about the trial, including the risks and benefits of participating. Patients complete the informed consent processes, including signing the form, before they can participate in the trial.
Recruitment materials: These materials are used to recruit patients for the trial. They may include brochures, flyers, or website content.
Study information sheets: These sheets provide patients with more detailed information about the trial, such as the study protocol, the schedule of visits, and the potential side effects of the treatment.
Questionnaires: Patients may be asked to complete questionnaires at various points during the trial. These questionnaires may collect information about their health, their quality of life, or their experiences with the treatment.
Patient diaries: Patients may be asked to keep a diary of their symptoms, their experiences with the treatment, or their thoughts and feelings about the trial.

DCT-specific Considerations/Inputs

Patient-facing materials for a decentralized clinical trial (DCT) may differ from those for a traditional clinical trial in a number of ways. Consider these factors while developing materials to support participants and their families / caregivers in DCTs:

Location: DCTs have assessments and/or visits conducted at locations other than a traditional research site. Patient-facing materials need to be designed for patients who will be participating from home or another non-clinical setting. This may mean using different languages, providing more detailed instructions, or including more information about how to access support services.
Technology: DCTs often rely on digital tools, and may include direct data capture by participants. Patient-facing materials need to be clear about how patients are expected to use these technologies to participate in the trial. This may include providing instructions on how to download and use apps, how to upload data, or how to communicate with the study team through secure messaging platforms.
Communication: DCTs often require more frequent communication between patients and the study team, so patient-facing materials need to emphasize the importance of staying in touch with the team and reporting any changes in health or side effects. This may include providing contact information for the research study team, instructions on how to report adverse events, or tips for managing any challenges that may arise during the trial.
Support: It is important to provide participants with support throughout the trial. This may include providing access to educational resources, connecting them with technical support teams, and offering financial support to enable participation. All of these mechanisms of support need to be clearly explained to participants to help them stay connected to the trial and the research team.

Additionally, any DCT technologies and services need to be clearly explained to participants in the Informed Consent Document. Some Ethics Boards may require screen shots of any patient facing materials, including recruitment materials, survey questions or other data collection forms, etc.