An interventional study of E-health program in Chronic Pain, sponsored by University of Cincinnati. Completed at 2 sites in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Treatment
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.
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.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 402 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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
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
| Milestone | Treatment As Usual | E-Health+ |
|---|---|---|
| Started | 202 | 200 |
| Completed | 202 | 196 |
| Not completed | 0 | 4 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Death | 0 | 1 |
Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
| Participants | Treatment As Usual | E-Health+ |
|---|---|---|
| Decrease in Morphine Equivalent Dose (MED) | 85 | 105 |
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.
| Participants | Treatment As Usual | E-Health+ |
|---|---|---|
| Pain Intensity | 13 | 24 |
Collected over Randomization through Month 10. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment As Usual | 0/202 (0%) | 0/202 (0%) | 95/202 (47%) |
| E-Health+ | 1/200 (0.5%) | 0/200 (0%) | 85/200 (42.5%) |
| Event | Treatment As Usual | E-Health+ |
|---|---|---|
| Worsening of AnxietyPsychiatric disorders | 36/202 | 39/200 |
| Worsening of DepressionPsychiatric disorders | 37/202 | 30/200 |
| Worsening of Pain InterferenceGeneral disorders | 35/202 | 29/200 |
| Worsening of StressPsychiatric disorders | 20/202 | 23/200 |
| Worsening of Pain IntensityGeneral disorders | 21/202 | 18/200 |
| Age, Categorical(Participants) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 155 | 160 | 315 |
| >=65 years | 47 | 40 | 87 |
| Age, Continuous(years) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| Mean | 56.9 ± 10.9 | 56.4 ± 11.1 | 56.7 ± 11.0 |
| Sex: Female, Male(Participants) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| Female | 140 | 139 | 279 |
| Male | 62 | 61 | 123 |
| Ethnicity (NIH/OMB)(Participants) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 189 | 191 | 380 |
| Unknown or Not Reported | 11 | 6 | 17 |
| Race (NIH/OMB)(Participants) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 1 | 5 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 29 | 43 | 72 |
| White | 154 | 147 | 301 |
| More than one race | 3 | 3 | 6 |
| Unknown or Not Reported | 11 | 5 | 16 |
| Region of Enrollment(participants) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| United States | 202 | 200 | 401 |
| Morphine Equivalent Dose (MED)(Morphine Equivalent Dose) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| Mean | 47.8 ± 53.4 | 48.1 ± 63.6 | 48.0 ± 58.6 |
| Pain Intensity(Score on a scale) | Treatment As Usual | E-Health+ | Total |
|---|---|---|---|
| Mean | 5.9 ± 1.6 | 5.9 ± 1.5 | 5.9 ± 1.6 |
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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