Stefan Elbers

193 AGRIPPA: protocol for an RCT To match the existing treatment content and procedures, the moment that the app will be introduced to patients can vary between locations. During the treatment phase, the app is considered a supplement to the main treatment activities and patients are free to decide how and when to use the app. Health care providers will be instructed to encourage and facilitate using the strategies when they expect it will reinforce the treatment process. However, both strategies can largely be used independently of any treatment activity and are expected to minimally affect direct treatment time. A member of the research team will be available to the treatment staff throughout the experimental phase for additional questions, support, and discussions regarding optimal use. Following treatment, there will be no additional monitoring in the enhanced treatment condition. Patients will continue to be able to use the app at their discretion. Posttreatment data will be obtained directly posttreatment (t1), and at 3 months (t2), 6 months (t3), and 12 months (t4) posttreatment. RESULTS The trial has been registered in the Netherlands Trial Register under the identifier NL8076. The study is ongoing. The patient inclusion period started in October 2019 and is expected to end in November 2020. As of March 20, 2020, we have recruited 88 patients. Results are expected to be released in the final quarter of 2021. In the last meeting of 2020, the steering committee will initiate the formation of writing teams that will be responsible for the final trial report. DISCUSSION Study Goals This study will evaluate the AGRIPPA app in the context of interdisciplinary multimodal pain treatment progammes. Specifically, we will investigate the effect of app use on long- term pain disability and efficiency by means of a cost-effectiveness analysis. To discover how patients interact with the app, we will also explore usability and engagement and test the impact of these variables on pain disability. Together, these analyses will help to demonstrate to what extent the AGRIPPA app contributes to preventing relapse in pain- related disability. In contrast to prevailing intervention development guidelines, the AGRIPPA development project adopted a co-design approach and started with collecting qualitative data from end users (e.g., patients and health care providers) rather than with formulating a theoretical framework. Although co-design is increasingly acknowledged in the health care domain