Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients

Обзор

Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood. The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability. Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app.

Подробное описание

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 and the World Health Organization guidelines on the management of chronic pain in children. The intervention will use validated psychological techniques (particularly Cognitive Behavioral Therapy and Acceptance and Commitment Therapy) focused on improving functioning by teaching pain coping skills, such as: relaxation, goal setting, sleep management, behavioral activation, self-management of negative thoughts and emotions, and communication skills.

Phase 3) Effectiveness and Implementation study. Participants (n = 195) will be adolescents 12-17 years old with chronic pain admitted into any of 6 large hospitals in Spain and one of their parents.

Вмешательства

• Поведенческое Digital SPA
  A psychological digital intervention for chronic pain in adolescents, based on evidence-based Acceptance and Commitment Therapy techniques. The intervention will be co-created with patients in a previous phase of the study, so the exact number or format of sessions and content has not been determined yet.

Первичные конечные точки

• Change in Pain Interference [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Global impression of change after treatment [Срок оценки: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Change in the number of visits to the Emergency Room (ER) due to pain [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]

Вторичные конечные точки (10)

• Change in pain readiness to change [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Change in the dose of pain medication taken [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Change in the type of pain medication taken [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Change in Emotional Distress [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Change in Functional Disability [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Change in Sleep [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Change in Pain Self-efficacy [Срок оценки: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Psychological Flexibility and Inflexibility Processes [Срок оценки: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).]
• Satisfaction with treatment [Срок оценки: Post-treatment (T3; 8 weeks after T1).]
• Adherence to treatment [Срок оценки: From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks.]

Критерии участия

Критерии включения

• Adolescents age 12-17 years
• Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain)
• Has Internet access
• One parent is willing to participate (and both give consent for their child to participate)

Критерии исключения

• Diagnosis of a comorbid serious health condition (e.g., cancer)
• Parent or child does not speak or read Spanish
• Active psychosis or suicidal ideation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 6 центров

• Hospital Materno Infantil Torrecardenas — Almería
• Hospital Sant Joan de Déu — Barcelona
• Hospital Materno Infantil Virgen de las Nieves — Granada
• Hospital infantil del Hospital Universitario La Paz — Madrid
• Hospital General Universitario Santa Lucía — Cartagena
• Hospital Materno Infantil del Hospital Regional Universitario — Málaga

Публикации

• de la Vega R, Serrano-Ibanez ER, Ruiz-Parraga GT, Palermo TM, Wicksell R, Fernandez-Jimenez E, Oliva S, Roldan S, Monfort L, Pelaez MJ, Leyva Carmona M, Ramirez-Maestre C, Lopez-Martinez AE, Miro J, Esteve R. 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). D PMID 38130799

Идентификаторы

NCT: NCT05917626 · PID2021-122885OA-I00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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