Chronic PainAIM-CPNCT06407115
Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain
A study testing Cognitive Behavioral Therapy (CBT), Exercise Counseling and tele-EnhanceFitness and Care Coordination in people with Chronic Pain, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Cognitive Behavioral Therapy (CBT), Exercise Counseling and tele-EnhanceFitness and Care Coordination
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current primary care patient with one care visit in the last year
- Have a chronic pain diagnosis (more than 3 months)
- Live in a rural area
- Proficient in English or Spanish
- A total score ≥ 12 on the 3-item Pain, Enjoyment, and General Activities scale
Who cannot join
- Ongoing treatment with chemotherapy and/or radiation therapy
- Scheduled surgical procedures in the next 6 months
- Has received skills training or education for pain management in the past 6 months
- Moderate or severe cognitive impairment (documented Alzheimer's or dementia diagnosis in EHR or score 12 or lower on the telephone Montreal Cognitive Assessment)
- Living in a nursing home or inpatient treatment facility
- Receipt of palliative care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health/Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Expanding Rural Access to Chronic Pain Care Through Nurse Care Management
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.
Read the detailed description
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.
- Conditions
- Chronic Pain
- Being tested
- Cognitive Behavioral Therapy (CBT), Exercise Counseling and tele-EnhanceFitness, Care Coordination, Standard Clinical Practice Regimen
- Keywords
- chronic pain, behavioral health, rural health, telehealth, exercise
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
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.
Exercise Counseling and tele-EnhanceFitnessBehavioural
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.
Care CoordinationOther
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.
Standard Clinical Practice RegimenOther
Routine clinical care provided by the primary care team. This may include, consultations, medications, and referrals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Exercise Counseling and tele-EnhanceFitness; Other: Care Coordination; Other: Standard Clinical Practice Regimen |
| 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. Receives: Other: Standard Clinical Practice Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Secondary outcomes (9)
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.
Measured: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: 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.
Measured: Baseline, Post-Intervention (6 months after baseline) and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: Feasibility phase with a single intervention arm. Phase 2: RCT with two arms: the NCM model and treatment as usual.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Sebastian Tong, University of Washington
- Investigators
- Sebastian Tong, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407115
- Sponsor's protocol ID
- STUDY00019595
- Other IDs
- 1UG3NR020930, 4UH3NR020930-02
- Acronym
- AIM-CP
- Status last verified
- Apr 2026
- First submitted
- 6 May 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All trial outcomes data will be shared according to HEAL Initiative standards in the NIMH Data Archive.
Publications
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.
PubMed 42201860
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Rural Access to Chronic Pain Care Through Nurse Care Management
- ClinicalTrials.gov ID
- NCT06407115
- Acronym / sponsor ID
- AIM-CP / STUDY00019595
- Conditions
- Chronic Pain
- Keywords
- chronic pain, behavioral health, rural health, telehealth, exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: Feasibility phase with a single intervention arm. Phase 2: RCT with two arms: the NCM model and treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Nurse Care Manager Arm | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Exercise Counseling and tele-EnhanceFitness, Other: Care Coordination, Other: Standard Clinical Practice RegimenIn 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. |
| Treatment as Usual | Active comparator | Other: Standard Clinical Practice RegimenIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current primary care patient with one care visit in the last year
- Have a chronic pain diagnosis (more than 3 months)
- Live in a rural area
- Proficient in English or Spanish
- A total score ≥ 12 on the 3-item Pain, Enjoyment, and General Activities scale
Key exclusion criteria (6 listed)
- Ongoing treatment with chemotherapy and/or radiation therapy
- Scheduled surgical procedures in the next 6 months
- Has received skills training or education for pain management in the past 6 months
- Moderate or severe cognitive impairment (documented Alzheimer's or dementia diagnosis in EHR or score 12 or lower on the telephone Montreal Cognitive Assessment)
- Living in a nursing home or inpatient treatment facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)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. | Behavioural | Nurse Care Manager Arm |
| Exercise Counseling and tele-EnhanceFitnessParticipants 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. | Behavioural | Nurse Care Manager Arm |
| Care CoordinationCare 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. | Other | Nurse Care Manager Arm |
| Standard Clinical Practice RegimenRoutine clinical care provided by the primary care team. This may include, consultations, medications, and referrals. | Other | Nurse Care Manager Arm, Treatment as Usual |
Primary outcome
Pain Interference
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
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.
9 secondary outcomes
Physical functioning
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Pain catastrophizing
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Sleep Disturbance
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Depression
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Anxiety
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Unhealthy Substance Use
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Opioid Use
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Healthcare Utilization
Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Loneliness
Time frame: Baseline, Post-Intervention (6 months after baseline) and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42201860Keiser 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.
- Individual participant dataSharing planned: Yes. All trial outcomes data will be shared according to HEAL Initiative standards in the NIMH Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Tong, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT), Exercise Counseling and tele-EnhanceFitness and Care Coordination in people with Chronic Pain, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference (time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 4 Nov 2026.