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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX003169-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| VA Maryland Health Care System | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| User experiences with MEPS-Pain | Experimental | This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Completion | DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities | Average number activities logged per day in the App during week 5 Maximum score 12 (good outcome), minimum score 0 (bad outcome). | 5 weeks |
| Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth B. Hogans, MD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
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6/21/2022-7/15/2023; recruitment from medical center through clinic outreach and advertisement on research bulletin board
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| ID | Title | Description |
|---|---|---|
| FG000 | User Experiences With MEPS-Pain | This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm. Web-module for patient education and planning: Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | User Experiences With MEPS-Pain | This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm. Web-module for patient education and planning: Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Completed creation of a pain plan | Posted | Count of Participants | Participants | 6 weeks |
|
6 weeks
Adverse event collection performed at all in person visits and phone visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | User Experiences With MEPS-Pain | This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm. Web-module for patient education and planning: Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beth Hogans, M.D., Ph.D., Neurologist | VA Maryland Health Care System, Geriatric Research, Education, and Clinical Center | 410-605-7000 | beth.hogans@va.gov |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2022 | Nov 7, 2024 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2019 | Jul 11, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Pilot study of feasibility and user experience of minimal risk App for pain self-management intervention.
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Pain interference utilizing Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference measure Data are reported as scores in the PROMIS standardized scale derived by summing raw scores and converting this based on published conversion tables. 100 (bad outcome), 0 (good outcome). |
| 6 weeks |
| Actigraph Sleep-time Percentage | Actigraph sleep-time percentage - percent of time spent in sleep per adjudicated Actigraph recording 25-30% (good outcome), <20% or >40% (bad outcome) | 6 weeks |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Veteran | Count of Participants | Participants |
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| Primary | 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). | Completed system usability scale for the App | Posted | Mean | Standard Error | sum score | 6 weeks |
|
|
|
| Primary | 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). | Tablet-based application (App) use for pain self-management planning: total days with plan accessed | Posted | Mean | Full Range | Days plan accessed | 6 weeks |
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| Secondary | Pain Intensity Completion | DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome). | Pain intensity | Posted | Mean | Standard Error | score on a scale | 6 weeks |
|
|
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| Other Pre-specified | Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities | Average number activities logged per day in the App during week 5 Maximum score 12 (good outcome), minimum score 0 (bad outcome). | Average number activities logged per day in the App during week 5 on the days used | Posted | Mean | Standard Deviation | number activities logged per day of use | 5 weeks |
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|
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| Other Pre-specified | Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure | Pain interference utilizing Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference measure Data are reported as scores in the PROMIS standardized scale derived by summing raw scores and converting this based on published conversion tables. 100 (bad outcome), 0 (good outcome). | Participants initiating the study and not withdrawing | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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| Other Pre-specified | Actigraph Sleep-time Percentage | Actigraph sleep-time percentage - percent of time spent in sleep per adjudicated Actigraph recording 25-30% (good outcome), <20% or >40% (bad outcome) | Week 6, final visit | Posted | Mean | Standard Deviation | percent time in sleep | 6 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |