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Completed

NCT Number: NCT06665906

Using a Patient Navigator to Address the Social Drivers of Health in the Management of Pain

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.

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Key information

Conditions

Pain Agnosia Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Social intervention

Behavioral

At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

Primary outcomes

  1. 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).

  2. 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%).

  3. 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%).

  4. 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.

Other outcomes

  1. Pain, Enjoyment, General Activity (PEG) Survey

    Time frame: Baseline, Week 12, Week 24

    Pain, Enjoyment, General Activity (PEG) Survey asks three questions about pain severity. Total score range is 0-30. Higher scores represent worse pain.

  2. PROMIS Physical Functioning Short Form 6b

    Time frame: Baseline, Week 12, Week 24

    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.

  3. PROMIS Sleep Disturbance 6a+ Sleep Duration

    Time frame: Baseline, Week 12, Week 24

    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.

  4. Pain Catastrophizing Scale

    Time frame: Baseline, Week 12, Week 24

    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.

  5. PHQ-8

    Time frame: Baseline, Week 12, Week 24

    PHQ-8 is an 8 question survey assessing depression severity. Total score range from 0-24. Higher score indicates more severe depression.

  6. GAD-7

    Time frame: Baseline, Week 12, Week 24

    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.

  7. World Health Organization Quality of Life Survey

    Time frame: Baseline, Week 12, Week 24

    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.

  8. UCLA Loneliness Scale

    Time frame: Baseline, Week 12, Week 24

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Investigating the Use of A Patient Navigator to Address the Social Drivers of Health in the Management of Pain: A Pilot Study

Acronym: PANDA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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