Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain

Chronic Pain Clinical Trial

Official title:

Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076889
• Other study ID #: REB#
• Status: Recruiting
• Start date: October 31, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: The Hospital for Sick Children
• Contact: Jennifer N Stinson, RN, PhD
• Phone: 416-813-7654
• Email: jennifer.stinson[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The COVID-19 pandemic is presenting one of the greatest threats to youth mental health seen in generations. Pain is one of the most common symptoms of extreme stress in youth. In 2020, the investigators created an online "stepped-care" program called the Power over Pain Portal. Stepped care is a promising way to improve access to CP care. Stepped care tailors care based on a person's symptom severity. Like a ladder, a person must start with one type of care then "step up" or "step down" to more or less intense care depending on need. The investigators also summarized all online pain management programs for youth to find the best resources to embed into the Portal. The investigators will pilot-test the Portal with youth to ensure it can be implemented effectively and will be clinically beneficial. The investigators will recruit 100 youth with CP to use the Portal for 2 months and see how they interact with the features and if it helps to improve their pain and mental health. The investigators will include a mixture of youth who represent different ages, sexes, genders, sexual orientations, races, dwellings, and school/employment status.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Experience chronic pain

• Speak and read English

• Access to Internet / Smartphone (or will be loaned study phone with data plan)

• Intend to use the portal for 2 months

Exclusion Criteria:

• Youth self-reports:

• Receiving tertiary care or are on waitlists for tertiary care paediatric chronic pain programs

• Have moderate to severe cognitive impairment that may impact their ability to understand and use the Power over Pain Portal or complete self-reported outcomes

• Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality at the time of screening

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Power over Pain Portal
Youth from different ages, sexes, gender, sexual orientations, races, dwelling and school/employment status will receive access to the portal for 2 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	This will be assessed using the Acceptability e-Scale administered at T2 and assessed during the post-implementation qualitative interview. The minimum value is 1 and the maximum value is 5. Higher scores on the Acceptability e-Scale indicate a better outcome.	8 weeks
Primary	Adoption (i.e.,rate of uptake of the Power over Pain Portal)	Characterized via the user-level analytics of interactions with each feature. The benchmark will be 75% of users completing 3/4 portal assessment and accessing = portal intervention.	8 weeks
Primary	Appropriateness (i.e., perceived fit and compatibility of the Power over Pain Portal to the needs of users)	Assessed via the post-implementation qualitative interview.	8 weeks
Primary	Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned	Assessed using frequency counts and percentages of types/severity of problems encountered via monthly audit of technical support tickets	8 weeks
Primary	Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned	Assessed via characterization of the severity of encountered issues on the Power over Pain portal	8 weeks
Primary	Fidelity	Characterized by intervention use analytics.	8 weeks
Secondary	Client outcomes	Pain intensity as assessed by the 1-item PROMIS pediatric numeric rating scale v1.0 - Pain Intensity. This maximum score on the scale is 10 and the minimum score is 0, with higher scores indicating higher levels of pain experienced by the participant. This will be administered at T1 and T2	8 weeks
Secondary	Client outcomes	Pain interference as assessed by the the PROMIS pediatric short form v2.0 - Pain Interference 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher pain interference in the participant's life. This will be administered at T1 and T2.	8 weeks
Secondary	Client outcomes	Anxiety as assessed by the the PROMIS pediatric short form v2.0 - Anxiety 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher levels of anxiety in the participant's life. This will be administered at T1 and T2.	8 weeks
Secondary	Client outcomes	Depressive symptoms as assessed by the the PROMIS pediatric short form v2.0 - Depressive Symptoms 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher levels of depression in the participant's life. This will be administered at T1 and T2.	8 weeks
Secondary	Client outcomes	Insomnia as assessed by the the 7-item Insomnia Severity Index. The maximum score on the scale is 4 and the lowest score is 0, with higher scores indicating more severe levels of insomnia experienced by the patient. This will be administered at T1 and T2.	8 weeks