Chronic Pain
Conditions
Keywords
Opioid therapy, web-based intervention, self-management
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.
Interventions
BEHAVIORALE-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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 202 |
| 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.
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. | 200 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | E-Health+ | Treatment As Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 47 Participants | 87 Participants |
| Age, Categorical Between 18 and 65 years | 160 Participants | 155 Participants | 315 Participants |
| Age, Continuous | 56.4 years STANDARD_DEVIATION 11.1 | 56.9 years STANDARD_DEVIATION 10.9 | 56.7 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 191 Participants | 189 Participants | 380 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 17 Participants |
| Morphine Equivalent Dose (MED) | 48.1 Morphine Equivalent Dose STANDARD_DEVIATION 63.6 | 47.8 Morphine Equivalent Dose STANDARD_DEVIATION 53.4 | 48.0 Morphine Equivalent Dose STANDARD_DEVIATION 58.6 |
| Pain Intensity | 5.9 Score on a scale STANDARD_DEVIATION 1.5 | 5.9 Score on a scale STANDARD_DEVIATION 1.6 | 5.9 Score on a scale STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 29 Participants | 72 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) White | 147 Participants | 154 Participants | 301 Participants |
| Region of Enrollment United States | 200 participants | 202 participants | 401 participants |
| Sex: Female, Male Female | 139 Participants | 140 Participants | 279 Participants |
| Sex: Female, Male Male | 61 Participants | 62 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 202 | 1 / 200 |
| other Total, other adverse events | 95 / 202 | 85 / 200 |
| serious Total, serious adverse events | 0 / 202 | 0 / 200 |
Outcome results
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.
Time frame: Baseline and 10 months
Population: Three participants withdrew consent. (E-Health) One participant died. (E-Health) The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment As Usual | Decrease in Morphine Equivalent Dose (MED) | 85 Participants |
| E-Health+ | Decrease in Morphine Equivalent Dose (MED) | 105 Participants |
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.
Time frame: Baseline and 10 months
Population: Three participants withdrew consent. (E-Health) One participant died. (E-Health) The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment As Usual | Pain Intensity | 13 Participants |
| E-Health+ | Pain Intensity | 24 Participants |