WebMAP Mobile Self-management of Adolescent Chronic Pain

June 6, 2019 updated by: Tonya Palermo, Seattle Children's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
143

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 3 month followup

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain intensity
Time Frame: Baseline to 3 month followup
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
Time Frame: Baseline to 3 month followup
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
Time Frame: Baseline to 3 month followup
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
Time Frame: 3 month followup
1-item measure asking about change since receiving treatment
3 month followup
Change in parent behavior
Time Frame: Baseline to 3 month followup
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
Time Frame: Baseline to 3 month followup
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
Time Frame: Baseline to 3 month followup
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adoption - setting level
Time Frame: Assessed at 24 months
Proportion of children referred to WebMAP at each clinic/Number seen in each clinic
Assessed at 24 months
Reach
Time Frame: Assessed at 24 months
Number of people agree to participate/Number of eligible participants referred for intervention
Assessed at 24 months
Implementation, organization level
Time Frame: Assessed at 24 months
Provider survey regarding feasibility of implementing WebMAP and attitudes toward adoption
Assessed at 24 months
Maintenance, organization level
Time Frame: Assessed at 24 months
Proportion of clinics agreeing to continue using WebMAP
Assessed at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nationwide Children's Hospital
Children's Mercy Hospital Kansas City
C.S. Mott Children's Hospital
Connecticut Children's Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tonya Palermo, PhD, Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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