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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)

  • Datos identificativos

    Identificador: imarina:9333642
    Autores:
    de la Vega, RocioSerrano-Ibanez, Elena RRuiz-Parraga, Gema TPalermo, Tonya MWicksell, RikardFernandez-Jimenez, EduardoOliva, SilviaRoldan, SusanaMonfort, LauraPelaez, Maria JoseCarmona, Moises LeyvaRamirez-Maestre, CarmenLopez-Martinez, Alicia EMiro, JordiEsteve, Rosa
    Resumen:
    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/NCT0591762
  • Otros:

    Autor según el artículo: 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
    Departamento: Psicologia
    Autor/es de la URV: DE LA VEGA CARRANZA, ROCÍO / Miró Martínez, Jordi
    Palabras clave: Psychological intervention Implementation Digital health Commitment therapy Co-design Chronic pain Adolescents versions psychological intervention parent intensity implementation digital health co-design adolescents acceptance
    Resumen: 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.
    Áreas temáticas: 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
    Acceso a la licencia de uso: https://creativecommons.org/licenses/by/3.0/es/
    Direcció de correo del autor: jordi.miro@urv.cat
    Identificador del autor: 0000-0002-1998-6653
    Fecha de alta del registro: 2024-10-12
    Versión del articulo depositado: info:eu-repo/semantics/publishedVersion
    Enlace a la fuente original: https://journals.sagepub.com/doi/full/10.1177/20552076231219490
    URL Documento de licencia: https://repositori.urv.cat/ca/proteccio-de-dades/
    Referencia al articulo segun fuente origial: Digit Health. 9 20552076231219490-20552076231219490
    Referencia de l'ítem segons les normes 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
    DOI del artículo: 10.1177/20552076231219490
    Entidad: Universitat Rovira i Virgili
    Año de publicación de la revista: 2023
    Tipo de publicación: Journal Publications
  • Palabras clave:

    Computer Science Applications,Health Care Sciences & Services,Health Informatics,Health Information Management,Health Policy,Health Policy & Services,Medical Informatics,Public, Environmental & Occupational Health
    Psychological intervention
    Implementation
    Digital health
    Commitment therapy
    Co-design
    Chronic pain
    Adolescents
    versions
    psychological intervention
    parent
    intensity
    implementation
    digital health
    co-design
    adolescents
    acceptance
    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
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