WebMAP Mobile Self-management of Adolescent Chronic Pain

NCT03332563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2019-06-10

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Cognitive-behavioral intervention for chronic pain

WebMAP is a technology-based cognitive-behavioral intervention program that teaches relaxation skills, pain coping strategies and parent behavioral and communication techniques to youth with chronic pain and their parents.

Sponsors & Collaborators

  • Connecticut Children's Medical Center

    collaborator OTHER
  • Children's Mercy Hospital Kansas City

    collaborator OTHER
  • C.S. Mott Children's Hospital

    collaborator OTHER
  • Nationwide Children's Hospital

    collaborator OTHER
  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Tonya Palermo, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-05-14
Completion
2019-05-24

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332563 on ClinicalTrials.gov