WebMAP Mobile Self-management of Adolescent Chronic Pain

NCT03332563 | Completed

• 1 other identifier: Pfizer 27971161
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Pain

Keywords

Adolescent; Cognitive Behavioral Therapy; Chronic Pain; smartphone application; internet-delivered

Outcome Measures

Primary Outcomes (1)

• Change in activity limitations

  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

  Baseline to 3 month followup

Secondary Outcomes (7)

• Change in pain intensity

  Baseline to 3 month followup

• Change in anxiety and depressive symptoms

  Baseline to 3 month followup

• Change in pain-efficacy

  Baseline to 3 month followup

• Patient's global impression of change

  3 month followup

• Change in parent behavior

  Baseline to 3 month followup

Other Outcomes (4)

• Adoption - setting level

  Assessed at 24 months

• Reach

  Assessed at 24 months

• Implementation, organization level

  Assessed at 24 months

Study Arms (2)

WebMAP Mobile

EXPERIMENTAL

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.

Behavioral: Cognitive-behavioral intervention for chronic pain

Usual care

NO INTERVENTION

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.

Interventions

Cognitive-behavioral intervention for chronic pain BEHAVIORAL

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.

WebMAP Mobile

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Connecticut Children's Medical Center: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• C.S. Mott Children's Hospital: collaborator
• Nationwide Children's Hospital: collaborator

Study Sites (5)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Palermo TM, de la Vega R, Dudeney J, Murray C, Law E. Mobile health intervention for self-management of adolescent chronic pain (WebMAP mobile): Protocol for a hybrid effectiveness-implementation cluster randomized controlled trial. Contemp Clin Trials. 2018 Nov;74:55-60. doi: 10.1016/j.cct.2018.10.003. Epub 2018 Oct 2.

  PMID: 30290276 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonya Palermo, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Pain Medicine

Model Details: This study will employ a stepped wedge cluster randomized design in which clinic sites are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 8 clinics will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the clinic.

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 6, 2017
• Study Start: December 1, 2017
• Primary Completion: May 14, 2019
• Study Completion: May 24, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)