EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT03308188
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 402
• Locations: 2
• Arms: 2
• Actual Duration (Months): 44.8
• Patients Per Site: 201
• Patients Per Site Per Month: 4.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: E-health program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 402 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 5, 2018
• Actual Primary Completion Date: Oct 31, 2021
• Actual Study Completion Date: Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Treatment As Usual 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.
Experimental: E-Health+ 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.	Behavioral: E-health program; 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.

Outcome Measures

Primary Outcome Measures

1. Decrease in Morphine Equivalent Dose (MED) [Baseline and 10 months]

   Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.

Secondary Outcome Measures

1. Pain Intensity [Baseline and 10 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Health	Durham	North Carolina	United States	27710
2	UC Health	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• University of Cincinnati
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Theresa Winhusen, Ph.D., University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: T. John Winhusen, PhD, Professor; Vice Chair and Division Director of Addiction Sciences, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT03308188
• Other Study ID Numbers: 2017-2301; 1R01DA044248-01
• First Posted: Oct 12, 2017
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by T. John Winhusen, PhD, Professor; Vice Chair and Division Director of Addiction Sciences, University of Cincinnati: Opioid therapy; web-based intervention; self-management
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Feb 3, 2022