search
Back to results

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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-module for patient education and planning
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Low Back Pain focused on measuring Low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

User experiences with MEPS-Pain

Arm Description

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

Outcomes

Primary Outcome Measures

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. Plans will be assessed for appropriateness by pain clinician using a 0 to 10 scale: 0 meaning plan was not created, 1-10 rating quality of pain self-management plan on a scale of 1 being a 'worst imaginable' plan, 10 being a 'best imaginable' plan.
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).
Use of tablet-based application (App), patient experience via qualitative interview responses
The investigators will assess user experience with the App, using qualitative interview responses interview responses to semi-structured interview questions.
Pain intensity
DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome).
Tablet-based application (App) use for pain self-management planning: total clicks
Total daily clicks in the App Maximum score unknown (good outcome), minimum score 0 (bad outcome).
Tablet-based application (App) use for pain self-management planning: daily logging of activities
Average number activities logged per day in the App Maximum score unknown (good outcome), minimum score 0 (bad outcome).

Secondary Outcome Measures

Full Information

First Posted
June 25, 2019
Last Updated
August 2, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Maryland Health Care System
search

1. Study Identification

Unique Protocol Identification Number
NCT04075487
Brief Title
MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study
Acronym
MEPS-Pain
Official Title
Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Maryland Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Chronic low back pain is highly prevalent in Veterans, and is often resistant to pharmacological management so that non-pharmacological management is required. For many patients, the most effective approach is comprehensive pain management incorporating multiple therapies addressing: physical, mental, mind-body, sleep, safety, and environmental needs. The ultimate outcome is the development of a coordinated multidimensional evidence-based plan for pain self-management (C-MEPPS) tailored to each patient. This approach, while effective, is highly resource intensive and severely constrained by cost and health system factors. The investigators' goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan. This will represent a novel, scalable, Veteran-driven solution to chronic low back pain aligned with VA strategic objectives 'online navigator tools.empowers Veterans to make decisions.' The investigators are focused on transferring knowledge about evidence-base practices into the primary care context to help Veterans and their healthcare providers manage pain effectively- before it gets worse. The investigators have already developed the App prototype utilizing User-Centered Design principles to optimize the user experience. Our first aim is to develop and pilot test a web-based App for Veterans, including older Veterans and women Veterans, designed to empower each in pain self-management planning: providing access and data-driven guidance about evidence-based multidimensional behavior change. The investigators' second aim is to gather pilot data targeting patient-centered and rehabilitative outcomes such as: increased activity, more sleep time, decreased pain interference and better quality of life; through use of the App and engagement in pain self-management planning. This project brings together the expertise of skilled exercise physiologists, experienced pain and sleep clinical psychologists, pain specialists, clinical educators, geriatricians, women's health providers, and technology design experts to create a powerful new pipeline for knowledge transfer to patients and providers. Grounded in whole health and integrative approaches, nursing principles, pharmacy practices, physical therapy, and nutrition are also included in the App. The investigators are working as an interprofessional pain-focused team to put the best-available information about non-pharmacological treatments for pain into the hands of Veterans and their primary care providers. The investigators' vision is to improve the lives of Veterans with chronic low back pain, improving access to knowledge and resources and giving Veterans the power to plan their own path to better, more fulfilling living despite chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Low back pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study of feasibility and user experience of minimal risk App for pain self-management intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
User experiences with MEPS-Pain
Arm Type
Experimental
Arm Description
This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm.
Intervention Type
Other
Intervention Name(s)
Web-module for patient education and planning
Intervention Description
Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan
Primary Outcome Measure Information:
Title
Use of tablet-based application (App) for creation of pain self-management plan
Description
The investigators will assess user experience with the App, assessing actual use to create a pain self-management plan. Plans will be assessed for appropriateness by pain clinician using a 0 to 10 scale: 0 meaning plan was not created, 1-10 rating quality of pain self-management plan on a scale of 1 being a 'worst imaginable' plan, 10 being a 'best imaginable' plan.
Time Frame
8 weeks
Title
Tablet-based application (App) for pain self-management planning: patient experience via System usability scale
Description
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).
Time Frame
8 weeks
Title
Use of tablet-based application (App), patient experience via qualitative interview responses
Description
The investigators will assess user experience with the App, using qualitative interview responses interview responses to semi-structured interview questions.
Time Frame
8 weeks
Title
Pain intensity
Description
DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome).
Time Frame
8 weeks
Title
Tablet-based application (App) use for pain self-management planning: total clicks
Description
Total daily clicks in the App Maximum score unknown (good outcome), minimum score 0 (bad outcome).
Time Frame
8 weeks
Title
Tablet-based application (App) use for pain self-management planning: daily logging of activities
Description
Average number activities logged per day in the App Maximum score unknown (good outcome), minimum score 0 (bad outcome).
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference
Description
Pain interference utilizing PROMIS short form 6b Maximum score 30 (bad outcome), minimum score 6 (good outcome).
Time Frame
8 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance 4a Maximum score 20 (bad outcome), minimum score 4 (good outcome).
Time Frame
8 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Managing symptoms
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Managing symptoms 4a Maximum score 20 (good outcome), minimum score 4 (bad outcome).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth B. Hogans, MD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs