PainPANDANCT06665906
Using a Patient Navigator to Address the Social Drivers of Health in the Management of Pain
A study testing Web-Based Cognitive Behavioral Therapy (PainTrainer) and Social Intervention in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Web-Based Cognitive Behavioral Therapy (PainTrainer) and Social Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with daily pain for 3 months or longer
- Chronic daily musculoskeletal pain with Pain, Enjoyment, General Activity (PEG) Survey score >=4
- Primary care provider must be an Atrium provider
- Has at least one social driver of health: Financial insecurity, work and income, housing, food insecurity, safety, health literacy and at least one of the above, lack of social support and at least one of the above
Who cannot join
- Patients who have active cancer
- Cognitive impairment severe enough to preclude participation in a behavioral/lifestyle change program
- Live in a nursing home or inpatient treatment facility
- Unable to read and converse in English
- Those who are already connected to a patient navigator or nurse coordinator or social worker
- Planned elective surgery in the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Investigating the Use of A Patient Navigator to Address the Social Drivers of Health in the Management of Pain: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- Web-Based Cognitive Behavioral Therapy (PainTrainer), Social Intervention
- Keywords
- daily pain, musculoskeletal pain, pain management
- Medical subject headings
- Pain, Musculoskeletal Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Cognitive Behavioral Therapy (PainTrainer)Behavioural
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.
Social InterventionBehavioural
At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer); Behavioral: Social Intervention |
| 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. Receives: Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer); Behavioral: Social Intervention |
| 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. Receives: Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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%).
Measured: 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%).
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start19 Nov 2024
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Ang, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665906
- Sponsor's protocol ID
- IRB00118893
- Acronym
- PANDA
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of A Patient Navigator to Address the Social Drivers of Health in the Management of Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT06665906
- Acronym / sponsor ID
- PANDA / IRB00118893
- Conditions
- Pain
- Keywords
- daily pain, musculoskeletal pain, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 30 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PainTrainer Followed by Social Intervention | Experimental | Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer), Behavioral: Social InterventionAt 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. |
| Social Intervention Followed by PainTrainer | Experimental | Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer), Behavioral: Social InterventionParticipants 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. |
| PainTrainer Only | Experimental | Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with daily pain for 3 months or longer
- Chronic daily musculoskeletal pain with Pain, Enjoyment, General Activity (PEG) Survey score >=4
- Primary care provider must be an Atrium provider
- Has at least one social driver of health: Financial insecurity, work and income, housing, food insecurity, safety, health literacy and at least one of the above, lack of social support and at least one of the above
Key exclusion criteria (6 listed)
- Patients who have active cancer
- Cognitive impairment severe enough to preclude participation in a behavioral/lifestyle change program
- Live in a nursing home or inpatient treatment facility
- Unable to read and converse in English
- Those who are already connected to a patient navigator or nurse coordinator or social worker
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 |
|---|---|---|
| Web-Based Cognitive Behavioral Therapy (PainTrainer)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. | Behavioural | PainTrainer Followed by Social Intervention, PainTrainer Only, Social Intervention Followed by PainTrainer |
| Social InterventionAt least six phone call visits, plus or minus 4, with patient navigator to coordinate care. | Behavioural | PainTrainer Followed by Social Intervention, Social Intervention Followed by PainTrainer |
Primary outcome
Rate of Participant Recruitment
Time frame: Through study completion, on average 16 months
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).
Rate of Participant Retention
Time frame: Week 24
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%).
Rate of Participant Engagement with Patient Navigator
Time frame: Week 24
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%).
Rate of Participant Engagement with PainTrainer
Time frame: Week 24
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Dennis Ang, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Cognitive Behavioral Therapy (PainTrainer) and Social Intervention in people with Pain, run by Wake Forest University Health Sciences 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 4 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: finished, as of the sponsor's last update on 30 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Participant Recruitment (time frame: Through study completion, on average 16 months). The study lists 4 primary outcomes in all. 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 30 Jan 2026.