WebMAP Mobile Self-management of Adolescent Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332563
• Other study ID #: Pfizer 27971161
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 24, 2019

Study information

• Verified date: June 2019
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 24, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Seattle Children's Hospital	C.S. Mott Children's Hospital, Children's Mercy Hospital Kansas City, Connecticut Children's Medical Center, Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adoption - setting level	Proportion of children referred to WebMAP at each clinic/Number seen in each clinic	Assessed at 24 months
Other	Reach	Number of people agree to participate/Number of eligible participants referred for intervention	Assessed at 24 months
Other	Implementation, organization level	Provider survey regarding feasibility of implementing WebMAP and attitudes toward adoption	Assessed at 24 months
Other	Maintenance, organization level	Proportion of clinics agreeing to continue using WebMAP	Assessed at 24 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	Patient's global impression of change	1-item measure asking about change since receiving treatment	3 month followup
Secondary	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
Secondary	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
Secondary	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