Table 2 Implementation of Telemedicine into the ongoing ENTAiER-Trial – Tasks for the Study Team
Issue | Necessity, Challenge | Solution, Task |
|---|---|---|
Study design | Additional questions regarding - Feasibility (technology). - Practicability (users). - Satisfaction and acceptance (users). - Barriers (users and technology). - Interaction of patients and therapists. - Suitability of and improvement in the medium for therapists. - Technology and aspects of humanity and confidence. - The degree to which the therapist and participants connect during the exercises or are restrained by the technique. | - Adaptions in trial protocol and patient information. - Additional questions (quantitative analysis). - Possible change in the primary objective. - Qualitative substudy. - Focus group. - Potential filming of a subgroup for analysis. - Informed consent of the subgroup. - Adaptions in the statistical analysis. |
Study centres | - Increased participant need for information. - Little experience with media. | - Detailed information for participants, necessitating more time; repeat of information when distributing the study book. - Discussion of hurdles, fears, and barriers; if necessary, acquaintance with the media (e.g. test video call with a family member or friend during the baseline visit). - Technical instructions (must be repeated); for some participants, telephone support before the first group session. - Loan tablet, if necessary. - Instruction of assistance at home. |
Study organisation | - Study organisation, coordination, and management: Planning, organisation or all items, communication with all parties, adaptation of all trial documents, questionnaires, protocols, guidance, ethical approval, discussion with sponsor, adaptation according to EMA recommendations [7]. | |