MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study

NCT04075487 | Completed Results

• 2 other identifiers: A3169-PI21RX003169-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic low back pain is the #1 cause of disability and low quality of life in Veterans. Pain is a huge burden- stealing enjoyment, fulfillment, and time. Sometimes surgery, injections, or medications can help but sometimes not. Although no one solution fixes chronic low back pain, there are many treatments that can reduce pain impact and restore quality of life. These treatments involve: movement, psychology, mind-and-body therapies, sleep, and environmental factors. The challenge is how to best coordinate these treatments for chronic low back pain. The investigators have built a prototype mobile application that delivers the latest information to Veterans so they can work with healthcare providers to build their own pain self-management plans. With this new tool, the Veteran has data at hand and chooses their preferred pain self-management activities, making a coordinated plan that can be shared with their healthcare team. The investigators' goal is giving Veterans the knowledge and power to 'plan the work and work the plan' for chronic low back pain: restoring value, fulfillment, and meaning.

Conditions

Chronic Low Back Pain

Keywords

Low back pain

Outcome Measures

Primary Outcomes (3)

• Use of Tablet-based Application (App) for Creation of Pain Self-management Plan

  The investigators will assess user experience with the App, assessing actual use to create a pain self-management plan. Investigators will assess whether participants used the App to create a pain self-management plan on the tablet. The outcome will be the number of participants creating at least one pain self-management plan

  6 weeks

• Tablet-based Application (App) for Pain Self-management Planning: Patient Experience Via System Usability Scale

  The investigators will assess user experience with the App, usability with SUS, modified for App. Maximum score 50 (good outcome), minimum score 10 (poor outcome).

  6 weeks

• Tablet-based Application (App) Use for Pain Self-management Planning: Total Days With Plan Accessed

  Total days with plan accessed in the App Maximum score 42 (good outcome), minimum score 0 (bad outcome).

  6 weeks

Secondary Outcomes (1)

• Pain Intensity Completion

  6 weeks

Other Outcomes (3)

• Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities

  5 weeks

• Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure

  6 weeks

• Actigraph Sleep-time Percentage

  6 weeks

Study Arms (1)

User experiences with MEPS-Pain

EXPERIMENTAL

This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm.

Other: Web-module for patient education and planning

Interventions

Web-module for patient education and planning OTHER

Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan

User experiences with MEPS-Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans receiving care at the VAMHCS
• frequent or persistent low back pain (\> 3 months)
• pain \>4 on a 0-10 numeric rating scale
• willing to participate in trial of non-pharmacological therapies for pain
• ability to speak, read, and write as needed for study
• stable treatment

You may not qualify if:

• Veterans with cognitive or visual impairment limiting the ability to engage in self-directed self-management planning
• anticipated surgery or pain procedure during the expected study period

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Maryland Health Care System: collaborator

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Beth Hogans, M.D., Ph.D., Neurologist
• Organization: VA Maryland Health Care System, Geriatric Research, Education, and Clinical Center

beth.hogans@va.gov

410-605-7000

Study Officials

• Beth B. Hogans, MD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Pilot study of feasibility and user experience of minimal risk App for pain self-management intervention.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: August 30, 2019
• Study Start: June 21, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)