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The purpose of this study is to see if patients with chronic pain can improve how they manage their pain and daily function by working with a care manager and by learning pain coping skills from an online teaching tool.
This study will determine the effects of patient navigator-delivered care coordination to address the major social drivers of health on pain-related outcomes. All participants will have access to web-based cognitive behavior therapy (PainTrainer) - a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. Some participants will also receive phone call visits with patient navigator to coordinate care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PainTrainer Followed by Social Intervention | Experimental | At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. At Week 12, social intervention will begin. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care. |
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| Social Intervention Followed by PainTrainer | Experimental | Participants will have social intervention at study entry. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care. At week 12, web-based cognitive behavior therapy (PainTrainer) will begin. PainTrainer is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. |
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| PainTrainer Only | Experimental | At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-Based Cognitive Behavioral Therapy (PainTrainer) | Behavioral | Self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participant Recruitment | Mean number of participants recruited each month. Formula for calculation is planned number of enrolled and randomized participants (30) divided by total number of months needed to recruit 30 participants. The higher the number, the faster the recruitment is (i.e., 30 participants divided by 15 months = 2 per month). | Through study completion, on average 16 months |
| Rate of Participant Retention | Percentage of participants that completed study. Formula for calculation is number of participants that completed last study visit divided by the number of participants that were enrolled and randomized. Range 0 to 100%. The closer the percentage to 100%, the better is the follow-up rate (i.e., 26 completed week 24 study visit divided by 30 randomized participants = 86.6%). | Week 24 |
| Rate of Participant Engagement with Patient Navigator | Percentage of completed patient navigator phone calls. Formula for calculation is mean number of completed phone calls with the patient navigator divided by 6 scheduled phone calls. Range 0 to 100%. The higher the percentage, the better the rate of participant engagement with the patient navigator (i.e., 4 (average) number of completed phone calls divided by 6 scheduled calls = 66.6%). | Week 24 |
| Rate of Participant Engagement with PainTrainer | Percentage of completed PainTrainer modules. Formula for calculation is average number of completed PainTrainer modules divided by total number of modules (8). Range 0 to 100%. The closer the percentage to 100%, the better the rate of participant engagement with PainTrainer. | Week 24 |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain, Enjoyment, General Activity (PEG) Survey | Pain, Enjoyment, General Activity (PEG) Survey asks three questions about pain severity. Total score range is 0-30. Higher scores represent worse pain. | Baseline, Week 12, Week 24 |
| PROMIS Physical Functioning Short Form 6b |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Ang, MD | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2025 | Jan 28, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059352 | Musculoskeletal Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| D012947 | Social Work |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Social Intervention | Behavioral | At least six phone call visits, plus or minus 4, with patient navigator to coordinate care. |
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PROMIS Physical Functioning Short Form 6b is a 6 question survey about ability to perform basic physical daily activities. Total score range is 6-30. Higher score indicates better functioning. |
| Baseline, Week 12, Week 24 |
| PROMIS Sleep Disturbance 6a+ Sleep Duration | PROMIS Sleep Disturbance 6a+ Sleep Duration is a 13 question survey about sleep "over the past 7 days." Total score range from 13-65. Higher score indicates worse sleep and sleep related impairment. | Baseline, Week 12, Week 24 |
| Pain Catastrophizing Scale | Pain Catastrophizing Scale is a 6 question survey about how often a patient thinks catastrophically about their pain. Total scores range from 0-24. Higher score indicates increased thoughts and time spent on thinking about their pain. | Baseline, Week 12, Week 24 |
| PHQ-8 | PHQ-8 is an 8 question survey assessing depression severity. Total score range from 0-24. Higher score indicates more severe depression. | Baseline, Week 12, Week 24 |
| GAD-7 | GAD-7 is a 7 question survey assessing general anxiety "over the last 2 weeks." Total score range from 0-21. Higher score indicates more severe anxiety. | Baseline, Week 12, Week 24 |
| World Health Organization Quality of Life Survey | World Health Organization Quality of Life is a 2 question survey assessing patient perception of quality of life. Total score range from 2-10 for each question. Higher score indicates high quality of life perception. | Baseline, Week 12, Week 24 |
| UCLA Loneliness Scale | UCLA Loneliness Scale is a 3 question survey assessing social isolation. Total score range from 3-9. Higher score indicates higher level of social isolation. | Baseline, Week 12, Week 24 |
| D009140 | Musculoskeletal Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |