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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NR020930 | U.S. NIH Grant/Contract | View source | |
| 4UH3NR020930-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Chronic pain affects over 20% U.S. adults and has debilitating effects on quality of life and physical and mental health. Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain. The 46 million Americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. As such, a critical need exists to implement effective, comprehensive programs for pain management that include treatment options other than medications. Nurse care management (NCM) has been successfully used to enhance care for individuals with other long-term health issues. The study teams proposes to adapt, pilot, and implement a NCM model that includes care coordination, cognitive behavioral therapy (CBT), and referrals to a remotely delivered exercise program for rural patients with chronic pain.
Care managers will provide care coordination to help patients address their health holistically and help link them key resources in the community. In addition, the care managers will be trained to deliver cognitive behavioral therapy (CBT) to address unhelpful thought patterns and behaviors around chronic pain and also facilitate patients' participation in physical exercise. One exercise option offered is EnhanceFitness (tele-EF), an evidence-based exercise program that can be accessed from home. The rationale is that both tele-EF and CBT have been independently shown to improve pain, functioning, and quality of life and that care managers could support patients in accessing and engaging in these services.
Phase 1 allowed the study team to prepare for a randomized controlled trial to test the adapted NCM model with rural patients who have chronic pain. Investigators assessed feasibility of implementing this intervention in rural serving health care systems using two practice-based research networks with substantial rural presence, the WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) region Practice and Research Network and Mecklenburg Area Partnership for Primary Care Research in North Carolina. In combination, recruitment in these two networks will allow the study team to reach ethnically diverse participants across broad rural geographies.
Phase 2 is the randomized controlled trial across multiple sites of the integrated NCM model to test whether it is effective in reducing pain interference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse Care Manager Arm | Experimental | In this feasibility pilot, all participants will be assigned to work with a care manager for 6 months and receive all components of the intervention. The care manager will meet with participants in virtual appointments every month to create a care plan and monitor progress. The program will also include: 6-10 sessions of Cognitive Behavioral Therapy (CBT) for chronic pain, which focuses on skills and strategies to empower participants to better manage their pain. Finally, the Care Manager will help counsel participants on physical exercise and refer patients to tele-EnhanceFitness, an online community program that allows users to access instructor-led group exercise classes from home. |
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| Treatment as Usual | Active Comparator | In the Treatment as Usual arm, participants will continue receiving routine care from their primary care team. This may include referrals to specialists or allied health professionals, Given the heterogeneity among patients and between sites, it will be characterized in research assessments to allow for transparent reporting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | CBT in this study will consist of a series of 6-10, 30-45-minute sessions with the care manager. These 1-on-1 sessions will occur every week or every other week virtually. Content will be focus on addressing unhelpful thinking and small behavioral changes that may help participants better manage their pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | The Pain, Enjoyment and General Activities scale is a validated 3-item, 0-10 rating scale that measures pain intensity and pain interference with enjoyment of life and general activity. The 3 items are averaged to get the mean score (out of 10). A higher score indicates more severe pain and pain-related interference with life and activities. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functioning | The Patient Reported Outcomes Measurement Information (PROMIS) pain interference short form (version 6b) measures changes in functionality. Scores range from 6-30 that are converted to T-scores with a range of 0-100. Higher scores indicate better physical functioning. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Tong, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health/Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42201860 | Derived | Keiser B, Cortez K, Hoffman E, Wang J, Reeves K, Humbert A, Bailey RW, Shaw Welch S, Jawort S, Baldwin LM, Holtzer C, Tapp H, Ludden T, Belza B, Patel KV, Tong ST. Expanding rural access to chronic pain care through nurse care management: A hybrid type I effectiveness-implementation trial protocol. PLoS One. 2026 May 27;21(5):e0349526. doi: 10.1371/journal.pone.0349526. eCollection 2026. |
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All trial outcomes data will be shared according to HEAL Initiative standards in the NIMH Data Archive.
The protocol and analysis plan will be published in a peer-reviewed journal. It is pending review.
Open Access
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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 | Apr 1, 2026 |
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Phase 1: Feasibility phase with a single intervention arm. Phase 2: RCT with two arms: the NCM model and treatment as usual.
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| Exercise Counseling and tele-EnhanceFitness | Behavioral | Participants will be counseling on physical exercise and encouraged enroll in instructor-led exercises classes for up to an hour, 3 days per week. These classes can be accessed from home. Data plans and tablets are available to aid participants that need them to gain access to the classes. |
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| Care Coordination | Other | Care manager will meet with patient in virtual sessions once a month to create a care plan and monitor progress. Care manager will assess social determinants of health and link participants to resources in the community as appropriate. In addition, participants will take monthly assessments about pain and mood to help guide clinical decision making. |
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| Standard Clinical Practice Regimen | Other | Routine clinical care provided by the primary care team. This may include, consultations, medications, and referrals. |
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| Pain catastrophizing | The Patient Reported Outcomes Measurement Information (PROMIS) 6-item pain catastrophizing scale indicates the degree to which respondents have thoughts and feelings when they are experiencing pain. Scores are computed on a scale of 0-24 with higher scores indicating more catastrophic thoughts. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Sleep Disturbance | The Patient Reported Outcomes Measurement Information (PROMIS) 6-item sleep disturbance short form (version 6a) represents how much difficulty respondents have with sleep. It is scored from 6 to 30 and then converted to T-scores 0-100 with higher scales indicating more sleep problems. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Depression | The Personal Health Questionnaire (9-item) measures depressions symptoms. Scores range from 0 to 24 with higher scores indicating more severe depression. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Anxiety | The General Anxiety Disorder (7-item) measures anxiety symptoms. Scores range from 0 to 21 with higher scores indicating more severe anxiety. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Unhealthy Substance Use | The Tobacco, Alcohol, Prescription Medication, and Other Substance Use tool is a 4-item screener that identifies unhealthy substance use. Sum scores are not calculated for the 4-item screener. Unhealthy use is any use for the questions about prescription medication and other drugs and monthly use or more for the questions about tobacco and alcohol. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Opioid Use | Morphine Milligram Equivalents calculated by extracting prescription data from the electronic health record. | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Healthcare Utilization | Patient reported accounting of health services such as physical therapy, behavioral, primary care, urgent care, emergency room visits and referrals and appointments with specialists and/or allied health professionals (e.g., physical therapy, etc.). | Baseline, Post-intervention (6 months after baseline), 12-month follow-up |
| Loneliness | The UCLA Loneliness Scale (3-item) will be used to assess loneliness. It is scored on a scale from 3-9, with a threshold of 6 or greater indicating loneliness. | Baseline, Post-Intervention (6 months after baseline) and 12-month follow-up |
| Apr 20, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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