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Recruiting NCT05894772

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

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Power over Pain Portal.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • Acceptability [Time frame: 16 weeks]
  • Adoption [Time frame: 16 weeks]
  • Appropriateness [Time frame: 16 weeks]
  • Portal Feasibility [Time frame: 16 weeks]
  • Fidelity [Time frame: 16 weeks]
Secondary outcome measures (8)
  • Pain Intensity [Time frame: 16 weeks]
  • Pain Interference [Time frame: 16 weeks]
  • Anxiety [Time frame: 16 weeks]
  • Depression [Time frame: 16 weeks]
  • Insomnia [Time frame: 16 weeks]
  • Health Related Quality of Life [Time frame: 16 weeks]
  • School Attendance [Time frame: 16 weeks]
  • Healthcare Utilization [Time frame: 16 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 11 centers
  • IWK Health Center — Halifax
  • McMaster Children's Hospital — Hamilton
  • Children's Hospital London Health Sciences — London
  • Children's Hospital of Eastern Ontario (CHEO) — Ottawa
  • Hospital for Sick Children — Toronto
  • CHU Sainte-Justine — Montreal
  • Jim Pattison — Saskatoon
  • Alberta Children's Hospital — Calgary
  • … and 3 more centers

Identifiers

NCT: NCT05894772 · 4025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗