Stefan Elbers

176 Chapter 7 ABSTRACT Background: To facilitate adherence to adaptive pain management behaviours after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behaviour regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment progamme in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment progamme until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice. Trial Registration: Netherlands Trial Register NL8076; https://www.trialregister.nl/ trial/8076 International Registered Report Identifier (IRRID): DERR1-10.2196/18632 Key words: telemedicine; chronic pain; recurrence; clinical trial protocol; rehabilitation; randomized controlled trial; cost-benefit analysis; treatment adherence and compliance; mobile apps; patient care team.