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Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA) - imarina:9333642

URV's Author/s:DE LA VEGA CARRANZA, ROCÍO / Miró Martínez, Jordi
Author, as appears in the article.:de la Vega, Rocio; Serrano-Ibanez, Elena R; Ruiz-Parraga, Gema T; Palermo, Tonya M; Wicksell, Rikard; Fernandez-Jimenez, Eduardo; Oliva, Silvia; Roldan, Susana; Monfort, Laura; Pelaez, Maria Jose; Carmona, Moises Leyva; Ramirez-Maestre, Carmen; Lopez-Martinez, Alicia E; Miro, Jordi; Esteve, Rosa
Author's mail:jordi.miro@urv.cat
Author identifier:0000-0002-1998-6653
Journal publication year:2023
Publication Type:Journal Publications
APA:de la Vega, Rocio; Serrano-Ibanez, Elena R; Ruiz-Parraga, Gema T; Palermo, Tonya M; Wicksell, Rikard; Fernandez-Jimenez, Eduardo; Oliva, Silvia; Rolda (2023). Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA). Digit Health, 9(), 20552076231219490-20552076231219490. DOI: 10.1177/20552076231219490
Papper original source:Digit Health. 9 20552076231219490-20552076231219490
Abstract:Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain.(Phase 1) Focus groups with patients, parents, and clinicians (n = 5-6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness-implementation trial. Participants (n = 195) will be adolescents aged 12-17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation.This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation.ClinicalTrials.gov (registered on 26 June 2023: https://clinicaltrials.gov/study/NCT05917626). Contributions to the literature The implementation of digital health interventions has two major gaps: (1) adherence to treatment is suboptimal, and (2) the process of making the interventions available to the end-user in a sustainable way is often unsuccessful.In this study, we expect that assessing users' needs and co-designing an intervention with them will improve adherence.Documenting the implementation process from the project inception and integrating the results into an implementation framework will allow for replication and extension in different contexts.This study will increase the knowledge about implementation in a vulnerable population: adolescents with chronic pain without access to in-person multidisciplinary pain care.© The Author(s) 2023.
Article's DOI:10.1177/20552076231219490
Link to the original source:https://journals.sagepub.com/doi/full/10.1177/20552076231219490
Papper version:info:eu-repo/semantics/publishedVersion
licence for use:https://creativecommons.org/licenses/by/3.0/es/
Department:Psicologia
Licence document URL:https://repositori.urv.cat/ca/proteccio-de-dades/
Thematic Areas:Public, environmental & occupational health
Medical informatics
Health policy & services
Health policy
Health information management
Health informatics
Health care sciences & services
Computer science applications
Ciencias sociales
Keywords:Psychological intervention
Implementation
Digital health
Commitment therapy
Co-design
Chronic pain
Adolescents
versions
psychological intervention
parent
intensity
implementation
digital health
co-design
adolescents
acceptance
Entity:Universitat Rovira i Virgili
Record's date:2024-10-12
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