EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-health program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Opioid therapy, web-based intervention, self-management
Eligibility Criteria
Inclusion Criteria:
- Be 25-80 years of age
- Be able to understand the study, and having understood, provide informed consent in English
- Have a daily average prescribed MED ≥ 20 mg over a recent three-month period
- Have a chronic pain-related diagnosis
- Self-report current use of opioid medication(s) to treat pain
- Have a Brief Pain Inventory Pain Intensity score ≥3
- Have internet access and a working email account
Exclusion Criteria:
- Be anyone who, in the judgment of study staff, would be unlikely to complete the study (e.g., planning to change to a different primary care clinic, have a terminal illness, etc.)
- Be unwilling/unable to complete the WebNeuro assessments
- Be pregnant
- Be a prisoner
Sites / Locations
- Duke Health
- UC Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment As Usual
E-Health+
Arm Description
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
Outcomes
Primary Outcome Measures
Decrease in Morphine Equivalent Dose (MED)
Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
Secondary Outcome Measures
Pain Intensity
Whether (yes/no) there is a clinically meaningful decrease in pain intensity (at least 2 points) as measured by the Brief Pain Inventory (BPI), between baseline and 10-month post-randomization follow-up.
Full Information
NCT ID
NCT03308188
First Posted
October 6, 2017
Last Updated
September 26, 2023
Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03308188
Brief Title
EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications
Official Title
EMPOWER: Evaluating the Ability to Reduce Morphine Equivalent Dose for Chronic Pain Patients Receiving Opioid-therapy Through a Web-based E-Health Self-management Program: a Randomized Multi-site Clinical Trial in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a 10-month internet-based randomized controlled trial to evaluate whether an online chronic pain management program ("E-Health") can assist with reduced opioid reliance in chronic pain patients. About half of the eligible participants will receive access to the E-Health program in addition to their standard chronic pain treatment; the other half will just continue receiving their standard chronic pain treatment.
Detailed Description
This study will determine whether an innovative, accessible E-health intervention can assist with reduced opioid reliance in chronic pain patients, which can, ultimately, reduce risks of unintended opioid overdose and death. Importantly, the study will contribute to a better understanding of the mechanisms contributing to opioid use reduction while managing pain. The findings may assist in developing treatment options for a population at risk for opioid adverse effects.
Potential participants will be identified through electronic health record (EHR) queries at participating sites. Participants will be assessed at baseline, at the end of the 4-month treatment period, and at 6 months following end-of-treatment through an electronic data capture system accessed by the participants. Other outcome data will be obtained from the participant's EHR data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Opioid therapy, web-based intervention, self-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
Arm Title
E-Health+
Arm Type
Experimental
Arm Description
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
Intervention Type
Behavioral
Intervention Name(s)
E-health program
Intervention Description
The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
Primary Outcome Measure Information:
Title
Decrease in Morphine Equivalent Dose (MED)
Description
Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
Time Frame
Baseline and 10 months
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Whether (yes/no) there is a clinically meaningful decrease in pain intensity (at least 2 points) as measured by the Brief Pain Inventory (BPI), between baseline and 10-month post-randomization follow-up.
Time Frame
Baseline and 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be 25-80 years of age
Be able to understand the study, and having understood, provide informed consent in English
Have a daily average prescribed MED ≥ 20 mg over a recent three-month period
Have a chronic pain-related diagnosis
Self-report current use of opioid medication(s) to treat pain
Have a Brief Pain Inventory Pain Intensity score ≥3
Have internet access and a working email account
Exclusion Criteria:
Be anyone who, in the judgment of study staff, would be unlikely to complete the study (e.g., planning to change to a different primary care clinic, have a terminal illness, etc.)
Be unwilling/unable to complete the WebNeuro assessments
Be pregnant
Be a prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, Ph.D.
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Health
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications
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