Trial Outcomes & Findings for MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study (NCT NCT04075487)

Last Updated: 2025-07-31

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-07-31

Participant Flow

6/21/2022-7/15/2023; recruitment from medical center through clinic outreach and advertisement on research bulletin board

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	User Experiences With MEPS-Pain n=20 Participants 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants
Age, Continuous	61.5 years n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	14 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	14 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	20 Participants n=99 Participants
Veteran	20 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Completed creation of a pain plan

Outcome measures

Outcome measures
Measure	User Experiences With MEPS-Pain n=19 Participants 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
Use of Tablet-based Application (App) for Creation of Pain Self-management Plan	19 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Completed system usability scale for the App

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).

Outcome measures

Outcome measures
Measure	User Experiences With MEPS-Pain n=19 Participants 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
Tablet-based Application (App) for Pain Self-management Planning: Patient Experience Via System Usability Scale	39 sum score Standard Error 2.0

PRIMARY outcome

Timeframe: 6 weeks

Population: 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).

Outcome measures

Outcome measures
Measure	User Experiences With MEPS-Pain n=17 Participants 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
Tablet-based Application (App) Use for Pain Self-management Planning: Total Days With Plan Accessed	20 Days plan accessed Interval 0.0 to 38.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Pain intensity

DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome).

Outcome measures

Outcome measures
Measure	User Experiences With MEPS-Pain n=19 Participants 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
Pain Intensity Completion	5.1 score on a scale Standard Error .57

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 weeks

Population: Average number activities logged per day in the App during week 5 on the days used

Average number activities logged per day in the App during week 5 Maximum score 12 (good outcome), minimum score 0 (bad outcome).

Outcome measures

Outcome measures
Measure	User Experiences With MEPS-Pain n=19 Participants 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
Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities	7.2 number activities logged per day of use Standard Deviation 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: Participants initiating the study and not withdrawing

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).

Outcome measures

Outcome measures
Measure	User Experiences With MEPS-Pain n=19 Participants 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
Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure	59.0 score on a scale Standard Deviation 7.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: Week 6, final visit

Actigraph sleep-time percentage - percent of time spent in sleep per adjudicated Actigraph recording 25-30% (good outcome), \<20% or \>40% (bad outcome)

Outcome measures

Outcome measures
Measure	User Experiences With MEPS-Pain n=17 Participants 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
Actigraph Sleep-time Percentage	22.3 percent time in sleep Standard Deviation 8.7

Adverse Events

User Experiences With MEPS-Pain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Beth Hogans, M.D., Ph.D., Neurologist

VA Maryland Health Care System, Geriatric Research, Education, and Clinical Center

Phone: 410-605-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place