Clinical trial NCT03332563: WebMAP Mobile Self-management of Adolescent Chronic Pain
Official title: Web-based Self-management of Adolescent Chronic Pain: National Implementation Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Adolescent
Cognitive Behavioral Therapy
Chronic Pain
smartphone application
internet-delivered
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Connecticut Children's Medical Center
name: Children's Mercy Hospital Kansas City
name: C.S. Mott Children's Hospital
name: Nationwide Children's Hospital
First posted: 2017-11-06
Enrollment: 143
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in activity limitations
timeFrame: Baseline to 3 month followup
Secondary outcomes:
measure: Change in pain intensity
timeFrame: Baseline to 3 month followup
measure: Change in anxiety and depressive symptoms
timeFrame: Baseline to 3 month followup
measure: Change in pain-efficacy
timeFrame: Baseline to 3 month followup
measure: Patient's global impression of change
timeFrame: 3 month followup
measure: Change in parent behavior
timeFrame: Baseline to 3 month followup
measure: Change in parent emotional distress
timeFrame: Baseline to 3 month followup
measure: Change in insomnia severity
timeFrame: Baseline to 3 month followup
Other outcomes:
measure: Adoption - setting level
timeFrame: Assessed at 24 months
measure: Reach
timeFrame: Assessed at 24 months
measure: Implementation, organization level
timeFrame: Assessed at 24 months
measure: Maintenance, organization level
timeFrame: Assessed at 24 months
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Tonya Palermo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.