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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05894772
Enrollment
93
Registered
2023-06-08
Start date
2023-08-05
Completion date
2025-09-01
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Brief 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.

Interventions

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.

Sponsors

University of Calgary
CollaboratorOTHER
University of Saskatchewan
CollaboratorOTHER
Centre for Addiction and Mental Health
CollaboratorOTHER
University of British Columbia
CollaboratorOTHER
Memorial University of Newfoundland
CollaboratorOTHER
University of Alberta
CollaboratorOTHER
St. Justine's Hospital
CollaboratorOTHER
McMaster Children's Hospital
CollaboratorOTHER
Dalhousie University
CollaboratorOTHER
Montreal Children's Hospital of the MUHC
CollaboratorOTHER
Children's Hospital of Eastern Ontario
CollaboratorOTHER
Provincial Health Services Authority British Columbia
CollaboratorOTHER
Seattle Children's Hospital
CollaboratorOTHER
University Health Network, Toronto
CollaboratorOTHER
London Health Sciences Centre
CollaboratorOTHER
Quebec Pain Research Network
CollaboratorOTHER
The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Implementation-effectiveness quasi-experimental design

Eligibility

Sex/Gender
ALL
Age
12 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability16 weeksWill 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.
Adoption16 weeksCharacterized via participant-level analytics of interactions with each feature. The benchmark will be \>60% of participants completing ≥ 1 portal intervention.
Appropriateness16 weeksPerceived fit and compatibility of portal participants' needs. Assessed via the qualitative interview at T2.
Portal Feasibility16 weeksDegree 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.
Fidelity16 weeksDegree to which the PoP Portal and each intervention independently (WEBMap, iCanCope, iPeer2Peer) was used as intended. Will be characterized by intervention use analytics.

Secondary

MeasureTime frameDescription
Health Related Quality of Life16 weeksWill be assessed using a 7-item PROMIS Paediatric Global Health Short-form Scales with higher scores representing overall better health.
Pain Intensity16 weeksWill be measured using the PROMIS Pain Intensity Scale which assesses pain the past 7 days using an 11-point numerical rating scale (NRS) with verbal anchors no pain at 0 and worst pain you can think of at 10. This tool demonstrates relevance, feasibility, and understandability for youth with chronic pain.
Healthcare Utilization16 weeksWill capture family physician and emergency visits, psychological or physical therapies and changes in medication, using a CP modified version of Ambulatory and Home Care Record at T1 and T2.
School Attendance16 weeksWill be assessed using a single item modified by investigators to capture school absenteeism as a continuous variable ranging from 0 to 240 days. Self-report of school attendance among a CP population is comparable to school administrative data.
Pain Interference16 weeksWill be assessed using the PROMIS Pain Interference Short-form Scale and 8-item tool that uses a 5-point Likert scale, ranging from never to almost always, with higher scores representing greater interference with function.
Anxiety16 weeksWill be assessed using a PROMIS Paediatric Anxiety Short-form Scale, an 8-item tool that uses a 5-point Likert scale, ranging from never to almost always, with higher scores representing more anxiety symptoms.
Depression16 weeksWill be assessed using PROMIS Paediatric Depression Short-form Scale, an 8-item tool that used a 5-point Likert scale, ranging from never to almost always, with higher scores representing more depressive symptoms.
Insomnia16 weeksWill be assessed using a 7-item Insomnia Severity Index, higher score representing more severe insomnia.

Countries

Canada

Contacts

Primary ContactJennifer N Stinson, RN, PhD
jennifer.stinson@sickkids.ca416-813-7654
Backup ContactChitra Lalloo, PhD
chitra.lalloo@sickkids.ca416-813-7654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026