RESUMO
Data tracking is a common feature of pain e-health applications, however, viewing visualizations of this data has not been investigated for its potential as an intervention itself. We conducted a pilot feasibility parallel randomized cross-over trial, 1:1 allocation ratio. Participants were youth age 12-18 years recruited from a tertiary-level pediatric chronic pain clinic in Western Canada. Participants completed two weeks of Ecological Momentary Assessment (EMA) data collection, one of which also included access to a data visualization platform to view their results. Order of weeks was randomized, participants were not masked to group assignment. Objectives were to establish feasibility related to recruitment, retention, and participant experience. Of 146 youth approached, 48 were eligible and consented to participation, two actively withdrew prior to the EMA. Most participants reported satisfaction with the process and provided feedback on additional variables of interest. Technical issues with the data collection platform impacted participant experience and data analysis, and only 48% viewed the visualizations. Four youth reported adverse events not related to visualizations. Data visualization offers a promising clinical tool, and patient experience feedback is critical to modifying the platform and addressing technical issues to prepare for deployment in a larger trial.
RESUMO
BACKGROUND: Chronic pain is a common and costly condition in youth, associated with negative implications that reach far beyond the pain experience itself (e.g., interference with recreational, social, and academic activities, mental health sequelae). As a self-appraised condition, pain experience is influenced by patient's biases and meaning-making in relation to their symptoms and triggers. We propose that interacting with self-reported data will impact the experience of pain by altering understanding and expectations of symptom experience and how pain interacts with other factors (e.g., sleep, emotions, social interactions). In this study, we aim to establish the feasibility and acceptability of using a data visualization platform to track and monitor symptoms and their relationship with other factors, versus simply daily reporting of symptoms using a smartphone-based Ecological Momentary Assessment (EMA). METHODS: This protocol is for a randomized, single-center, open-label crossover trial. We aim to recruit 50 typically developing youth aged 12-18 years with chronic pain to take part in two phases of data collection. The trial will utilize an A-B counterbalanced design in which participants will be randomly assigned to receive either Part A (EMA alone for 7 days) or Part B (EMA plus visualization platform for 7 days) first and then receive the opposite phase after a 7-day break (washout period). Key outcomes will be participant reports of acceptability and feasibility, EMA completion rates, barriers, and perceptions of the benefits or risks of participation. Secondary exploratory analyses will examine the relationship between EMA-reported symptoms over time and in relation to baseline measures, as well as pilot data on any improvements in symptoms related to engaging with the data visualization platform. DISCUSSION: This protocol describes the feasibility and pilot testing of a novel approach to promoting self-management and facilitating symptom appraisal using visualized data. We aim to determine whether there is a sufficient rationale, both from the perspective of feasibility and patient satisfaction/acceptability, to conduct a larger randomized controlled trial of this intervention. This intervention has the potential to support clinical care for youth with chronic pain and other conditions where self-appraisal and understanding of symptom patterns are a critical component of functional recovery. TRIAL REGISTRATION: Open Science Framework doi: https://doi.org/10.17605/OSF.IO/HQX7C . Registered on October 25, 2021, osf.io/hqx7c.
