Chronic PainPhase 3CORPsNCT06091202
Tele-Collaborative Outreach to Rural Patients With Chronic Pain
A Phase 3 study testing CORPs Intervention in people with Chronic Pain, run by Oregon Health and Science University at 4 sites in United States.
Trial summary
This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. 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?
- CORPs Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 608 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jul 2024to 1 Jun 2027
- Phase
- Phase 3
- 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
- U.S. Veteran
- Rural Residence based on Rural Urban Commuting Area codes
- High Impact Chronic pain, determined through a phone screening
- Access to landline or cell phone
- English Speaking
Who cannot join
- Cognitive impairment that would impact participation in the study
- Plans to move in the next 3 months
- Surgery in the past 3 months
- In long-term inpatient or hospice care
- Terminal illness (defined as life expectancy of less than 12 months)
- Active participation in another pain intervention study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA North Texas Health Care System
Dallas, Texas, 75216
VA Minneapolis Health Care System
Minneapolis, Minnesota, 55417
VA Tennessee Valley Health Care System
Nashville, Tennessee, 37212
VA Portland Health Care System
Portland, Oregon, 97239
About this study
Official title: Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial
This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. minimally enhanced usual care to improve pain interference over 12 months of follow-up, and (2) oversample women and rural veterans of minoritized race/ethnicity to test heterogeneity of treatment effects across birth sex and race/ethnicity.
Read the detailed description
The CORPs trial is a multisite pragmatic effectiveness trial taking place at four geographically diverse VA sites. The CORPs trial will assess the effectiveness of a nurse-led tele-collaborative pain care intervention (CORPs) compared to a one-time education session with a nurse (minimally enhanced usual care, or MEUC) at improving pain and health outcomes for Veterans living in rural areas. This study focuses on management of pain with non-medication services and therapies.
Veterans who enroll will participate for 12-months and will be randomized to one of 2 groups: 1) CORPs (with access to a nurse by phone/video for the duration of the study), or 2) One-time education session with the nurse by phone/video to review resources for pain. All participants complete research assessments at the start of the study, and at 3-, 6-, 9-, and 12-months by phone.
- Conditions
- Chronic Pain
- Being tested
- CORPs Intervention, Minimally Enhanced Usual Care (MEUC)
- Keywords
- Rural, Pain, CIH, Veteran
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORPs InterventionBehavioural
Also called Nurse-led collaborative care
Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference.
After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months.
A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.
Minimally Enhanced Usual Care (MEUC)Behavioural
Also called One-time Education Session
Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference.
After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months.
A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| CORPs Intervention | Active comparator | The CORPs Intervention is a nurse-led intervention.
A) An intake assessment with a Nurse Care Manager at the start of the study by phone or video to discuss the patient's pain experience, care options, and goals. Resources are provided and focus on non-medication options at the VA, and as appropriate, in the community.
B) 5 Check-in phone/video appointments with a Nurse Care Manager, scheduled to take place near 2-, 4-, 8-, 12-, and 16-weeks. These visits will provide further assistance with goal planning and care coordination for pain management.
C) Optional 6-week virtual group education class covering topics like complementary and integrative approaches to pain, sleep and pain, and the neurobiology of pain.
D) Patients in this arm can contact their nurse with questions for the full 12 months of participation. Receives: Behavioral: CORPs Intervention |
| Minimally Enhanced Usual Care (MEUC) | Placebo comparator | The minimally enhanced usual care arm is a one-time education session.
A) One-time education session with a Nurse Care Manager by phone/video to review pain resources. These resources focus on non-medication options at the VA, and as appropriate, in the community. Receives: Behavioral: Minimally Enhanced Usual Care (MEUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference - Brief Pain Inventory (BPI)
Pain Interference subscale from the Brief Pain Inventory. Scores are reported on a range of 0 - 10, with higher scores indicating more impairment due to pain.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Secondary outcomes (8)
Pain Intensity - Brief Pain Inventory (BPI)
Scores are on a range of 0 - 10, with higher scores indicating more severe pain.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Physical Functioning - PROMIS Physical Functioning Scale
Physical Functioning will be assessed with the 4-item PROMIS Physical Functioning scale. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Quality of Life - Veterans RAND-12 (VR-12)
Quality of Life will be assessed with the Veterans RAND 12-item Health Survey (VR-12). VR-12 scores are summarized into two scores, a Physical Health component score and a Mental Health component score. Each component score is on a range of 0 - 100, with higher scores indicating more impairment in physical or mental health, respectively.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9). Scores on the PHQ-9 range from 0 - 24, with higher scores indicating more severe symptoms of depression.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptoms will be assessed with the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Scores on the PHQ-9 range from 0 - 24, with higher scores indicating more severe symptoms of depression. Scores on the GAD-7 range from 0 - 21, with higher scores indicating more severe symptoms of anxiety.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Suicidal Behavior - Electronic Health Record (EHR)
Data on suicidal behaviors will be extracted from the electronic health record.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Quality of Sleep - PROMIS Sleep Disturbance Scale
Quality of sleep will be assessed with the PROMIS Sleep Disturbance 4-item short-form. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Engagement in Non-Pharmacological Services/Treatments - Nonpharmacological Self-Care Approaches survey (NSCAP)
Engagement in nonpharmacological pain treatment will be assess with the Use of Nonpharmacological Self-Care Approaches survey (NSCAP). This survey assesses the number of times each of 9 treatments were used in the past 3 months.
Measured: Baseline, 3-, 6-, 9-, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start11 Jul 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Portland VA Medical Center, Minneapolis Veterans Affairs Medical Center, North Texas Veterans Healthcare System, VA Tennessee Valley Health Care System
- Responsible party
- Principal investigator, Travis Lovejoy, Oregon Health and Science University
- Investigators
- Travis Lovejoy, PhD, MPH, Principal investigator, Oregon Health & Science University, VA Portland Health Care SystemBenjamin Morasco, PhD, Principal investigator, Oregon Health & Science University, VA Portland Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091202
- Sponsor's protocol ID
- 25384
- Other IDs
- 1UG3AT012257-01, 4UH3AT012257-02
- Acronym
- CORPs
- Status last verified
- May 2026
- First submitted
- 13 Oct 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial
- ClinicalTrials.gov ID
- NCT06091202
- Acronym / sponsor ID
- CORPs / 25384
- Conditions
- Chronic Pain
- Keywords
- Rural, Pain, CIH, Veteran
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Portland VA Medical Center, Minneapolis Veterans Affairs Medical Center, North Texas Veterans Healthcare System, VA Tennessee Valley Health Care System
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Oct 2023 (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.
This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. minimally enhanced usual care to improve pain interference over 12 months of follow-up, and (2) oversample women and rural veterans of minoritized race/ethnicity to test heterogeneity of treatment effects across birth sex and race/ethnicity.
Detailed description
The CORPs trial is a multisite pragmatic effectiveness trial taking place at four geographically diverse VA sites. The CORPs trial will assess the effectiveness of a nurse-led tele-collaborative pain care intervention (CORPs) compared to a one-time education session with a nurse (minimally enhanced usual care, or MEUC) at improving pain and health outcomes for Veterans living in rural areas. This study focuses on management of pain with non-medication services and therapies.
Veterans who enroll will participate for 12-months and will be randomized to one of 2 groups: 1) CORPs (with access to a nurse by phone/video for the duration of the study), or 2) One-time education session with the nurse by phone/video to review resources for pain. All participants complete research assessments at the start of the study, and at 3-, 6-, 9-, and 12-months by phone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORPs Intervention | Active comparator | Behavioral: CORPs InterventionThe CORPs Intervention is a nurse-led intervention. A) An intake assessment with a Nurse Care Manager at the start of the study by phone or video to discuss the patient's pain experience, care options, and goals. Resources are provided and focus on non-medication options at the VA, and as appropriate, in the community. B) 5 Check-in phone/video appointments with a Nurse Care Manager, scheduled to take place near 2-, 4-, 8-, 12-, and 16-weeks. These visits will provide further assistance with goal planning and care coordination for pain management. C) Optional 6-week virtual group education class covering topics like complementary and integrative approaches to pain, sleep and pain, and the neurobiology of pain. D) Patients in this arm can contact their nurse with questions for the full 12 months of participation. |
| Minimally Enhanced Usual Care (MEUC) | Placebo comparator | Behavioral: Minimally Enhanced Usual Care (MEUC)The minimally enhanced usual care arm is a one-time education session. A) One-time education session with a Nurse Care Manager by phone/video to review pain resources. These resources focus on non-medication options at the VA, and as appropriate, in the community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- U.S. Veteran
- Rural Residence based on Rural Urban Commuting Area codes
- High Impact Chronic pain, determined through a phone screening
- Access to landline or cell phone
- English Speaking
Key exclusion criteria (6 listed)
- Cognitive impairment that would impact participation in the study
- Plans to move in the next 3 months
- Surgery in the past 3 months
- In long-term inpatient or hospice care
- Terminal illness (defined as life expectancy of less than 12 months)
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 |
|---|---|---|
| CORPs InterventionAlso: Nurse-led collaborative careParticipants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up. | Behavioural | CORPs Intervention |
| Minimally Enhanced Usual Care (MEUC)Also: One-time Education SessionParticipants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up. | Behavioural | Minimally Enhanced Usual Care (MEUC) |
Primary outcome
Pain Interference - Brief Pain Inventory (BPI)
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Pain Interference subscale from the Brief Pain Inventory. Scores are reported on a range of 0 - 10, with higher scores indicating more impairment due to pain.
8 secondary outcomes
Pain Intensity - Brief Pain Inventory (BPI)
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Physical Functioning - PROMIS Physical Functioning Scale
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Quality of Life - Veterans RAND-12 (VR-12)
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Suicidal Behavior - Electronic Health Record (EHR)
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Quality of Sleep - PROMIS Sleep Disturbance Scale
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Engagement in Non-Pharmacological Services/Treatments - Nonpharmacological Self-Care Approaches survey (NSCAP)
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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 28 May 2026.
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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. This study is not recruiting at the moment.
Travis Lovejoy, PhD, MPH principal investigator
Oregon Health & Science University, VA Portland Health Care System
Benjamin Morasco, PhD principal investigator
Oregon Health & Science University, VA Portland Health Care System
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CORPs Intervention in people with Chronic Pain, run by Oregon Health and Science University at 4 sites 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 - Brief Pain Inventory (BPI) (time frame: Baseline, 3-, 6-, 9-, and 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.