Clinical trial NCT05917626: Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
Official title: Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Adolescents
Digital Health
Psychological Intervention
Co-development
Implementation
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2023-06-26
Enrollment: 195
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study will employ a stepped wedge cluster randomized design in which hospitals are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 6 hospitals will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the hospital.
Primary purpose: TREATMENT

Brief summary: 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 (adolescents) or a website (parents).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Pain Interference
timeFrame: 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).
measure: Global impression of change after treatment
timeFrame: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
measure: Change in the number of visits to the Emergency Room (ER) due to pain
timeFrame: 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).
Secondary outcomes:
measure: Change in pain readiness to change
timeFrame: 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).
measure: Change in the dose of pain medication taken
timeFrame: 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).
measure: Change in the type of pain medication taken
timeFrame: 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).
measure: Change in Emotional Distress
timeFrame: 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).
measure: Change in Functional Disability
timeFrame: 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).
measure: Change in Sleep
timeFrame: 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).
measure: Change in Self-efficacy
timeFrame: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
measure: Satisfaction with treatment
timeFrame: Post-treatment (T3; 8 weeks after T1).
measure: Adherence to treatment
timeFrame: From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks.
Other outcomes:
measure: Adverse Events (side effects)
timeFrame: Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Locations:
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucía
state: Murcia
city: Almería
country: Spain
facility: Hospital Materno Infantil Torrecardenas
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
city: Granada
country: Spain
facility: Hospital Materno Infantil Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital infantil del Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Materno Infantil del Hospital Regional Universitario
Study officials:
affiliation: University of Malaga
name: Rocio de la Vega, PhD
role: PRINCIPAL_INVESTIGATOR
References: