Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND To facilitate adherence to adaptive pain management behaviours after interdisciplinary multimodal pain treatment, we developed an mHealth application (i.e. AGRIPPA app) that contains two behaviour regulation strategies. OBJECTIVE This study has three main objectives: (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 multicentre randomised 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 program in one of the six 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 program until 12 months post-treatment. 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 healthcare expenses. RESULTS The study was approved by the local Medical Research Ethics Committee in October 2019. As of 20 March 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 three years of development and feasibility testing, this formal evaluation will help determine to what extent the application will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice. CLINICALTRIAL The trial has been registered under NL8076 in the Netherlands Trial Register (https://www.trialregister.nl/trial/8076)