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Recruiting Not applicable

Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness Hybrid Type III Study

NCT05894772 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2023-08-05
Last updated
2025-07-04

Condition(s) studied

Chronic Pain

Investigational drug(s) / intervention(s)

Power over Pain Portal

Power over Pain Portal: Youth from different ages, sexes, gender, sexual orientations, races, dwelling and school/employment status will receive access to the Power over Pain Portal for 4 months. The portal consists of self-assessment tools (bi-weekly check-ins to provide users with feedback on their mood, anxiety, pain, and sleep and guide decision making on choice of interventions), evidence-based virtual educational (pain neuroscience) and cognitive behavioural therapy (CBT) pain interventions that are delivered in a stepped care manner based on participant needs/preference. The overall objective is to determine the implementation (guided by Proctor's implementation conceptual framework) and clinical effectiveness of the PoP Portal in a sample of youth (12-18 years of age) who are on the waitlist for tertiary care consultation at any pediatric CP clinic in Canada.

Study summary

Pain is one of the most common symptoms of extreme stress in youth. Without treatment, short-term pain can last for months to years (called 'chronic pain'; CP), a problem already affecting 1 in 5 Canadian youth. The COVID-19 pandemic is one of the greatest threats to youth mental health seen in generations. CP in childhood can trigger a wave of mental health issues that last well into adulthood. In 2019, we learned that "access to pain care" is poor and a priority for youth with CP and their families. Unfortunately, COVID-19 has only made access more difficult. In 2020, we created an online "stepped care" program called the Power over Pain Portal for youth with CP. Stepped care is a promising way to improve access to CP care by tailoring care based on the symptoms each youth is experiencing. Like a ladder, youth start with one type of care and then "step up" or "step down" to more or less intense care depending on what they need. Over the past year, funded by CIHR, we worked with hundreds of youth and healthcare professionals across Canada to understand how the pandemic has affected pain and mental health. We also summarized all online pain self-management programs including peer support for youth to find the best resources to include in the Portal and will translate the portal content into French. Together with a diverse group of youth with CP, we have now co-designed the online Portal. The next step (focus of this grant) is to test the Portal with youth to ensure it can be implemented and is helpful. We will recruit 93 youth with CP waiting for specialist care at 11 CP clinics across Canada to use the Portal for 4 months. We will see how they use the Portal and if it helps to improve their pain and mental health. This study is important because it will allow us to understand how the Portal works in the real world before wide public release (English and French) to support all youth in Canada with CP with accessible, evidence-based pain care.

Eligibility

Sex
ALL
Min age
12 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Experience chronic pain * Speak and read English or French * Have access to internet / smartphone (or are willing to be loaned a study phone with a data plan) * Are on the waitlist of a tertiary care CP clinic in Canada * Intend to use the PoP Portal for at least 4 months * Have the capacity to consent Exclusion Criteria: * Have moderate to severe cognitive impairments that may impact their ability to understand and use the PoP Portal or complete self-reported clinical outcome measures * Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality as assessed by the PoP Portal screening. Youth who have co-occurring clinically significant anxiety or depression that is currently being treated will be eligible if they meet other inclusion criteria.

Primary outcome measure(s)

  • Acceptability — 16 weeks
    Will be assessed using the Acceptability e-Scale administered at T2 and during the qualitative interview. Participants rate features of the portal on a scale from 1-5 with higher scores indicating higher acceptability.
  • Adoption — 16 weeks
    Characterized via participant-level analytics of interactions with each feature. The benchmark will be \>60% of participants completing ≥ 1 portal intervention.
  • Appropriateness — 16 weeks
    Perceived fit and compatibility of portal participants' needs. Assessed via the qualitative interview at T2.
  • Portal Feasibility — 16 weeks
    Degree to which to PoP Portal could be used as intended. Will be assessed via monthly audit of support tickets and characterization of the severity of encountered issues.
  • Fidelity — 16 weeks
    Degree to which the PoP Portal and each intervention independently (WEBMap, iCanCope, iPeer2Peer) was used as intended. Will be characterized by intervention use analytics.

Trial sites (11)

FacilityCityRegionStatus
IWK Health Center Halifax Nova Scotia Not Yet Recruiting
McMaster Children's Hospital Hamilton Ontario Recruiting
Children's Hospital London Health Sciences London Ontario Not Yet Recruiting
Children's Hospital of Eastern Ontario (CHEO) Ottawa Ontario Not Yet Recruiting
Hospital for Sick Children Toronto Ontario Recruiting
CHU Sainte-Justine Montreal Quebec Not Yet Recruiting
Jim Pattison Saskatoon Saskatchewan Not Yet Recruiting
Alberta Children's Hospital Calgary Canada Not Yet Recruiting
Stollery Children's Hospital Edmonton Canada Not Yet Recruiting
Montreal Children's Hospital Montreal Canada Not Yet Recruiting
BC Children's Hospital Vancouver Canada Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05894772 on ClinicalTrials.gov ↗ ← All trials in Canada