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

NCT ID: NCT05894772

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-05

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Implementation-effectiveness quasi-experimental design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm

Power over Pain Portal

Group Type EXPERIMENTAL

Power over Pain Portal

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role collaborator

McMaster Children's Hospital

OTHER

Sponsor Role collaborator

Dalhousie University

OTHER

Sponsor Role collaborator

Montreal Children's Hospital of the MUHC

OTHER

Sponsor Role collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role collaborator

Provincial Health Services Authority

OTHER

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

Quebec Pain Research Network

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Stinson

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IWK Health Center

Halifax, Nova Scotia, Canada

Site Status NOT_YET_RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Children's Hospital London Health Sciences

London, Ontario, Canada

Site Status NOT_YET_RECRUITING

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, Canada

Site Status NOT_YET_RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Jim Pattison

Saskatoon, Saskatchewan, Canada

Site Status NOT_YET_RECRUITING

Alberta Children's Hospital

Calgary, , Canada

Site Status NOT_YET_RECRUITING

Stollery Children's Hospital

Edmonton, , Canada

Site Status NOT_YET_RECRUITING

Montreal Children's Hospital

Montreal, , Canada

Site Status NOT_YET_RECRUITING

BC Children's Hospital

Vancouver, , Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Jennifer N Stinson, RN, PhD

Role: CONTACT

416-813-7654 ext. 304514

Chitra Lalloo, PhD

Role: CONTACT

416-813-7654 ext. 302332

Facility Contacts

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Adam Huber, MD

Role: primary

Serina Patel, MD

Role: primary

519.685.8500 ext. 52678

Ciaran Duffy, MSc, FRCPC

Role: primary

Karen Watanabe Duffy, MD, FRCPC

Role: backup

Rachel Kelly, BA

Role: primary

416-813-7654 ext. 302314

Chitra Lalloo, BHSc, PhD

Role: backup

416-813-7654 ext. 302332

Craig Eling

Role: primary

Other Identifiers

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4025

Identifier Type: -

Identifier Source: org_study_id

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