WebMAP Mobile Self-management of Adolescent Chronic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Cognitive-behavioral intervention for chronic pain

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C.S. Mott Children's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospitals and Clinics
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WebMAP Mobile; 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; 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.
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity	Pain intensity will be measured prospectively on the 11-point Pain Numeric Rating Scale (NRS) with anchors of 0 (no pain) to 10 (worst pain possible). Average scores over 7-day assessment periods will be used in analyses.	Baseline to 3 month followup
Change in anxiety and depressive symptoms	Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress scale is an 8-item scale of anxiety with scores ranging from 8 to 40 (higher scores indicate greater fear, anxious misery, and hyperarousal). The 8-item scale of depressive symptoms has scores ranging from 8 to 40 with higher scores indicating greater depressive symptoms. Total anxiety and total depression T-scores will be used in analyses.	Baseline to 3 month followup
Change in pain-efficacy	Pain Self-Efficacy Scale-4 is a 4-item measure that assesses beliefs in carrying out activities when in pain. Total sum score ranging from 0 to 24 will be used in analysis with higher scores representing greater self-efficacy.	Baseline to 3 month followup
Patient's global impression of change	1-item measure asking about change since receiving treatment	3 month followup
Change in parent behavior	Parents report on their protective behaviors on the Adult Responses to Child Symptoms (ARCS), a 29-item scale with subscale scores for three factors, Protect, Minimize, Distract and Monitor. Each subscale is scored by computing the mean of the item responses ranging from 0 to 4 (higher scores indicate more maladaptive behaviors)	Baseline to 3 month followup
Change in parent emotional distress	Parents report on their anxiety and depression symptoms on the PROMIS Adult Emotional Distress scale. This includes a 4-item scale of anxiety with scores ranging from 4 to 20 (higher scores indicate greater anxiety), and a 4-item scale of depression with scores ranging from 4 to 20 (higher scores indicate greater depression. Total anxiety and depression scale T-scores will be used in analyses.	Baseline to 3 month followup
Change in insomnia severity	Insomnia Severity Index is a 7-item self-report measure. A 5-point Likert scale is used to rate each item about the severity and impact of insomnia symptoms with scores ranging from 0 to 28 (higher scores indicate greater insomnia sympotoms). A Total score will be used in analyses.	Baseline to 3 month followup

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption - setting level	Proportion of children referred to WebMAP at each clinic/Number seen in each clinic	Assessed at 24 months
Reach	Number of people agree to participate/Number of eligible participants referred for intervention	Assessed at 24 months
Implementation, organization level	Provider survey regarding feasibility of implementing WebMAP and attitudes toward adoption	Assessed at 24 months
Maintenance, organization level	Proportion of clinics agreeing to continue using WebMAP	Assessed at 24 months

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Nationwide Children's Hospital; Children's Mercy Hospital Kansas City; C.S. Mott Children's Hospital; Connecticut Children's Medical Center
• Investigators: Principal Investigator: Tonya Palermo, PhD, Seattle Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 24, 2019

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Adolescent; Chronic Pain; smartphone application; Cognitive Behavioral Therapy; internet-delivered
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Pfizer 27971161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No