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

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Recruiting
CT.gov ID
NCT06076889
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
100
1
12
8.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Power over Pain Portal

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain
Actual Study Start Date :
Oct 31, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Acceptability [8 weeks]

    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.

  2. Adoption (i.e.,rate of uptake of the Power over Pain Portal) [8 weeks]

    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.

  3. Appropriateness (i.e., perceived fit and compatibility of the Power over Pain Portal to the needs of users) [8 weeks]

    Assessed via the post-implementation qualitative interview.

  4. Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned [8 weeks]

    Assessed using frequency counts and percentages of types/severity of problems encountered via monthly audit of technical support tickets

  5. Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned [8 weeks]

    Assessed via characterization of the severity of encountered issues on the Power over Pain portal

  6. Fidelity [8 weeks]

    Characterized by intervention use analytics.

Secondary Outcome Measures

  1. Client outcomes [8 weeks]

    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

  2. Client outcomes [8 weeks]

    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.

  3. Client outcomes [8 weeks]

    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.

  4. Client outcomes [8 weeks]

    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.

  5. Client outcomes [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children
  • Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Stinson, Clinician Scientist, Clinical Nurse Specialist/NP, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT06076889
Other Study ID Numbers:
  • REB#
First Posted:
Oct 11, 2023
Last Update Posted:
Oct 11, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2023