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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA044248-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual | No Intervention | 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. | |
| E-Health+ | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-health program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Winhusen, Ph.D. | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Health | Durham | North Carolina | 27710 | United States | ||
| UC Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36525381 | Derived | Wilson M, Dolor RJ, Lewis D, Regan SL, Vonder Meulen MB, Winhusen TJ. Opioid dose and pain effects of an online pain self-management program to augment usual care in adults with chronic pain: a multisite randomized clinical trial. Pain. 2023 Apr 1;164(4):877-885. doi: 10.1097/j.pain.0000000000002785. Epub 2022 Sep 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | E-Health+ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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) | Posted | Count of Participants | Participants | Baseline and 10 months |
|
Randomization through Month 10
A potential AE is defined as >30% symptom deterioration from baseline as indicated by any of the following: 1) Pain Intensity score or Pain Interference score as measured by the BPI; 2) Depression, Anxiety, or Stress score from the DASS-21. Additionally, to meet criteria for an AE, these follow-up scores must fall within at least the "moderate" range of severity for the respective measures. A report identifying participants with AEs defined as above was generated on a weekly basis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Pain Intensity | General disorders | BPI | Systematic Assessment | Per BPI |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. John Winhusen, PhD. | University of Cincinnati | 513-585-8292 | winhust@ucmail.uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2019 | Aug 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Cincinnati |
| Ohio |
| 45229 |
| United States |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Morphine Equivalent Dose (MED) | Measure Analysis Population Description: The baseline morphine equivalent dose for one participant was an unusable outlier. MED, morphine equivalent dose (Treatment as Usual) | Mean | Standard Deviation | Morphine Equivalent Dose |
|
| Pain Intensity | The Brief Pain Inventory, Pain Intensity Subscale, range: 0-10, higher values indicate more intense pain, Mean (SD) | Mean | Standard Deviation | Score on a scale |
|
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.
|
|
| 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. | 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) | Posted | Count of Participants | Participants | Baseline and 10 months |
|
|
|
| 0 |
| 202 |
| 0 |
| 202 |
| 95 |
| 202 |
| EG001 | 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. | 1 | 200 | 0 | 200 | 85 | 200 |
| Worsening of Pain Interference | General disorders | BPI | Systematic Assessment | Per BPI |
|
| Worsening of Depression | Psychiatric disorders | DASS-21 | Systematic Assessment | Per DASS-21 |
|
| Worsening of Anxiety | Psychiatric disorders | DASS-21 | Systematic Assessment | Per DASS-21 |
|
| Worsening of Stress | Psychiatric disorders | DASS-21 | Systematic Assessment | Per DASS-21 |
|
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
|