WebMAP Mobile Self-management of Adolescent Chronic Pain

Seattle Children's Healthcare System

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: Cognitive-behavioral intervention for chronic pain

Study type: Interventional

Funder types: Other

Identifiers

NCT03332563

Pfizer 27971161

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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143 participants in 2 patient groups

WebMAP Mobile

Experimental group

Description:

Adolescent participants assigned to this arm will receive access to the WebMAP mobile program delivering cognitive-behavioral intervention for chronic pain. Parents of adolescents will receive access to cognitive-behavioral strategies for parents on the WebMAP parent web site.

Treatment:

Behavioral: Cognitive-behavioral intervention for chronic pain

Usual care

No Intervention group

Description:

Participants assigned to this arm will receive usual care from the pain or specialty clinic during the non-exposure periods in the stepped wedge design.