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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308188
• Other study ID #: 2017-2301
• Secondary ID: 1R01DA044248-01
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	UC Health	Cincinnati	Ohio
United States	Duke Health	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 10 months
Secondary	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.	Baseline and 10 months