- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075487
MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study (MEPS-Pain)
Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beth B Hogans, MD
- Phone Number: (410) 605-7000
- Email: Beth.Hogans@va.gov
Study Contact Backup
- Name: Leslie I Katzel, MD PhD
- Phone Number: (410) 605-7248
- Email: Leslie.Katzel@va.gov
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: User experiences with MEPS-Pain
This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm.
|
Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of tablet-based application (App) for creation of pain self-management plan
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Tablet-based application (App) for pain self-management planning: patient experience via System usability scale
Time Frame: 8 weeks
|
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). |
8 weeks
|
Use of tablet-based application (App), patient experience via qualitative interview responses
Time Frame: 8 weeks
|
The investigators will assess user experience with the App, using qualitative interview responses interview responses to semi-structured interview questions.
|
8 weeks
|
Pain intensity
Time Frame: 8 weeks
|
DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome). |
8 weeks
|
Tablet-based application (App) use for pain self-management planning: total clicks
Time Frame: 8 weeks
|
Total daily clicks in the App Maximum score unknown (good outcome), minimum score 0 (bad outcome). |
8 weeks
|
Tablet-based application (App) use for pain self-management planning: daily logging of activities
Time Frame: 8 weeks
|
Average number activities logged per day in the App Maximum score unknown (good outcome), minimum score 0 (bad outcome). |
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference
Time Frame: 8 weeks
|
Pain interference utilizing PROMIS short form 6b Maximum score 30 (bad outcome), minimum score 6 (good outcome). |
8 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance
Time Frame: 8 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance 4a Maximum score 20 (bad outcome), minimum score 4 (good outcome). |
8 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Managing symptoms
Time Frame: 8 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Managing symptoms 4a Maximum score 20 (good outcome), minimum score 4 (bad outcome). |
8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Beth B. Hogans, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3169-P
- I21RX003169-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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