82 Chapter 4 content of the application, might help to improve patients’ level of physical functioning in patients with LBP. Besides further development of the e-Exercise LBP intervention, several important methodological considerations were made with respect to the study design of the e-Exercise LBP trial. A first consideration was the use of a cluster-randomized controlled design to avoid contamination between the e-Exercise LBP intervention and usual physiotherapy care at the level of the participating physiotherapist. Cluster-randomization at the level of the participating physiotherapy practices ensures that each participating physiotherapist working in the same physiotherapy practice delivers the same intervention (89). The influence of clustering will be corrected using LMM in the statistical analysis. Since the e-Exercise LBP intervention aims to improve physical functioning, this outcome measurement was selected as primary outcome measurement. Intervention duration will last up to 3 months, but a 12-month evaluation will provide insight in the effectiveness of e-Exercise LBP on the long-term. However, with respect to the cost-effectiveness, it is hypothesized that patients who followed e-Exercise LBP are able to manage recurrent complaints independently, resulting in reduced healthcare usage or sickness absence. Since a 12-month follow-up might be too short to study this hypothesis, we added a 24month follow-up focusing on the management of recurrent complaints. Because the study design is well-considered, several potential operational issues are taken into account. An important operational issue is the physiotherapists’ training in the e-Exercise LBP intervention. From previous studies we learned that implementing a blended intervention into daily routine is a complex process that changes existing routines (28). Therefore, training of the participating physiotherapists in the e-Exercise LBP intervention has been expanded from a 4-h training session to two 4-h training sessions. Additionally, Siilo, a secure messenger for healthcare professionals to communicate and share information, will be used during the study to be able to provide direct assistance to participating physiotherapists. And finally, instruction videos were created to support physiotherapists in using the e-Exercise LBP intervention. Another important operational issue is the possible increased risk of drop- outs during this study due to the 24-month follow-up period and the 11 questionnaires that have to be completed during this period. To minimize this risk, a researcher (TK or RA) will conduct the follow-up assessments at 3, 12 and 24 months in person, i.e., by phone, Skype or face-to-face. A final operational issue is the belief that e-Exercise LBP will not provide a solution for all patients having LBP, nor for all physiotherapists treating patients with LBP. Therefore, selection bias could occur, e.g., participants or physiotherapists having low digital literacy skills, or have a more negative attitude towards technology in general, are less likely to be included in this study.
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