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NCT Number: NCT06932887

The Beat Pain Better Trial

The Beat Pain Better study examines strategies to increase the reach of evidence-based interventions for persons with osteoarthritis (OA) in communities that experience disparities. The study is a hybrid type 3 effectiveness-imple-mentation trial using sequential, multiple assignment, ran¬domi¬zation to evaluate 1) two text mes¬saging strat¬egies to reach persons with OA and enroll them in physical activity counseling provided by physical therapists; and 2) two strat¬egies to engage enrolled persons in the Walk with Ease (WWE) intervention for sustained self-management.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Association for Utah Community Health, Salt Lake City, Utah, United States

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About this study

We will conduct a hybrid type 3 effectiveness-imple¬mentation trial with a sequential, multiple assignment, ran¬domi¬zed design. Primary outcome is physical activity (PA) counseling reach (Aim 1). Secondary outcomes evaluate reach of WWE (Aim 2) and outcomes across RE-AIM domains (Aim 3). Persons with ICD-10 diagnosis codes indicating OA will be identified from EHRs in partnering clinics and sent text message (TM) invitations to participate in PA counseling. Phase I randomization will test two TM strategies: weekly TMs over 4 weeks with or without motiva¬tional messages. Phase II randomization for those who enroll in PA counseling and provide consent will test two formats for the WWE AAEBI; self-directed or enhanced self-directed delivery.

Participants will be randomized with 1:1 distribution at each randomization. Participants may consent and enroll for randomization to a WWE format even if they did not receive the TM intervention. The first randomization is performed using the TM platform (Azara or similar), stratified by site. The second randomization is performed using the REDCap randomization module, also stratified by site and by baseline PA level. Randomization schemas will be developed before enrollment. Randomization errors will be recorded as protocol deviations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 45 or older;
  • Visit in participating medical clinic within the past 6 months
  • OA diagnosis code related to lower extremity and/or spine on the problem list or associ¬ated with an encounter in the past 6 months
  • Has functioning cell phone able to receive calls and texts

Exclusion criteria

  • Unable to participate in a regular walking program defined as the ability to walk for at least five minutes with or without the use of an assistive device.
  • Medical contraindication to participation in physical activity
  • Unable to communicate in either Spanish or English

Treatment and study plan

Text messaging

Behavioral

Weekly SMS messages sent to potential participants to inform them of the opportunity to participate in PA counseling for their arthritis. instructions also provided on how to request a referral.

Motivational messaging

Behavioral

The use of short motivational messages along with text messages inviting persons to participate in PA counseling. The messages are intended to enhance the motivation to participate in PA counseling.

Physical Activity Counseling and Self-Directed Walk with Ease

Behavioral

All persons consenting to PA counseling receive 6 weekly sessions provided in-person or remote with 2-way video or audio commu¬nication. All participants receive education to address negative psy-chological appraisals of OA, reassur¬ance that PA is safe and beneficial, and a PA program primarily focused on walk¬ing, although additional activities may be included. Additional components include exercises tai¬lored to the partici¬pant's needs and coping strategies such as mindful breathing to help manage stress.

Enhanced Walk with Ease

Behavioral

Along with the portal registration participants in the Enhanced WWE group are also offered the opportunity to participate in virtual group WWE classes offered on a rolling basis in either English or Spanish.

Primary outcomes

  1. Reach-Enroll for PA Counseling

    Time frame: From time of initiating text messaging to enrollment

    Number of persons enrolling in PA counseling divided by the total number of persons eligible for enrollment

Secondary outcomes

  1. PEG-3

    Time frame: Baseline, 6, 12 and 26 weeks

    The PEG-3 is a self-report measure that includes 3 items evaluating 1) pain severity; and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores ranging from 0-10

  2. PROMIS Physical Function

    Time frame: Baseline, 6, 12 and 26 weeks

    The PROMIS short form 6b for physical function is a self-report that uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).

  3. PROMIS Sleep Disturbance

    Time frame: Baseline, 6, 12 and 26 weeks

    The PROMIS short form 6a for sleep disturbance is a self-report that uses fixed items from the PROMIS sleep disturbance item bank to provide a T-score with population mean = 50 (sd=10).

  4. PROMIS Depression

    Time frame: Baseline, 6, 12 and 26 weeks

    The PROMIS short form 8a for depression is a self-report that uses fixed items from the PROMIS depression item bank to provide a T-score with population mean = 50 (sd=10).

  5. Sleep Duration

    Time frame: Baseline, 6, 12 and 26 weeks

    The Sleep Duration Question asks; "During the past month, how many hours and minutes of actual sleep did you get at night?" Response is recorded in hours and minutes

  6. Pain Self-Efficacy

    Time frame: Baseline, 6, 12 and 26 weeks

    The Pain Self-Efficacy Scale is a 4-item scale assessing a person's confidence of persons to achieve goals and perform activities even with pain. Each item is scored from 0-6 for an overall score ranging from 0-24.

  7. High Impact Chronic Pain

    Time frame: 6, 12 and 26 weeks

    High impact chronic pain is based on responses to two questions; "In the past 3 months, how often do you have pain?" and "Over the past 3 months, how often did pain limit your life or work activities?" Response options for both questions are (0) Never, (1) Some Days, (2) Most days, (3) Every Day. A score of 2 or 3 on BOTH questions indicates the person has HICP.

  8. Physical Activity

    Time frame: Baseline, 6, 12 and 26 weeks

    The physical activity questionnaire asks respondents about their participation in physical activity and exercise within the past 6 weeks in 6 categories: 1) light physical activity (such as laundry, vacuuming, making beds or dusting); 2) moderate physical activity (such as scrubbing floors, washing windows, gardening or raking leaves); 3) heavy physical activity (such as carrying heavy objects, heavy digging, pushing a mower or hard manual labor); 4) light physical exercise (such as leisurely walking or slow dancing); 5) moderate physical exercise (such as hiking or swimming); and 6) vigorous physical exercise (such as jogging or playing tennis singles). For each category that the respondent indicates participating in, an additional question asks about the frequency at which they carried out these activities: ≤1 time/month, 2-3 times/month, 1-2 times/week, 3-4 times/week, 5-6 times/week, or daily

  9. Global Impression of Change

    Time frame: 6, 12 and 26 weeks

    Participants are asked their overall level of satisfaction with treatment with responses on a likert scale.

  10. Health care utilization

    Time frame: 6, 12 and 26 weeks

    Self-reported utilization of surgery, injections, imaging or other discrete interventions for pain associated with arthritis

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Fritz, PhD, PT

CONTACT

[email protected]

801-587-2237

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Mountain West Arthritis Secondary Prevention Program - The Beat Pain Better Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 17, 2025
Registry last updated
Jan 29, 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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