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Clinical Trials/NCT03332563
NCT03332563
Completed
Not Applicable

Web-based Self-management of Adolescent Chronic Pain: National Implementation Project

Seattle Children's Hospital5 sites in 1 country143 target enrollmentDecember 1, 2017
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Seattle Children's Hospital
Enrollment
143
Locations
5
Primary Endpoint
Change in activity limitations
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, data show that most youth do not have access to this intervention. The investigative team's prior studies demonstrate that technology-delivered pain self-management (WebMAP program) can reduce barriers to care, is feasible, acceptable, and effective in reducing pain-related disability and improving anxiety and depression in youth with chronic pain. In this trial, the investigators propose an implementation project to address critical challenges in nationwide dissemination of the WebMAP pain self-management program. Using a hybrid effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement WebMAP in the clinics following randomized usual care periods. Data will be collected from clinic records, web and app administrative tracking, and provider surveys to gather information on adoption and implementation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The expected outcome of the project is to yield a strategic approach for a nationwide technology-delivered pain self-management intervention for youth with chronic pain that can be readily sustained in clinical settings.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
May 24, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tonya Palermo

Professor, Anesthesiology and Pain Medicine

Seattle Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • child age 10-17 years,
  • has chronic pain defined as pain present for at least 3 months, and
  • has access to a smartphone or web-enabled device (e.g., laptop, computer, iPad).

Exclusion Criteria

  • non-English speaking,
  • presently in a psychiatric crisis,
  • cognitive impairments or intellectual disabilities (has to be able to complete surveys independently),
  • does not have access to a smartphone, computer, or internet, and
  • is unable to read at the 5th grade level.

Outcomes

Primary Outcomes

Change in activity limitations

Time Frame: Baseline to 3 month followup

The 9-item Child Activity Limitations Interview (CALI-9) will be completed on the online diary to rate perceived difficulty in completing 9 daily activities due to pain

Secondary Outcomes

  • Change in pain intensity(Baseline to 3 month followup)
  • Patient's global impression of change(3 month followup)
  • Change in anxiety and depressive symptoms(Baseline to 3 month followup)
  • Change in pain-efficacy(Baseline to 3 month followup)
  • Change in insomnia severity(Baseline to 3 month followup)
  • Change in parent behavior(Baseline to 3 month followup)
  • Change in parent emotional distress(Baseline to 3 month followup)

Study Sites (5)

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