The Beat Pain Better Trial

Mountain West Arthritis Secondary Prevention Program - 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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Chronic Pain Management
• Intervention / Treatment: Behavioral: Text Messaging; Behavioral: Motivational Messaging; Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease; Behavioral: Enhanced Walk with Ease

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 346
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Julie Fritz, PhD, PT; Phone Number: 801-587-2237; Email: julie.fritz@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Not yet recruiting
      • University of Utah
      • Contact: Julie Fritz, PhD, PT; Phone Number: 801-587-2237 8015991346; Email: julie.fritz@utah.edu
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • Association for Utah Community Health
      • Contact: Tracey Siaperas; Phone Number: (801) 974-5522; Email: tracey@auch.org
    • West Valley City, Utah, United States, 84120
      • Recruiting
      • Vamos Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 45 or older;
2. Visit in participating medical clinic within the past 6 months
3. 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
4. Has functioning cell phone able to receive calls and texts

Exclusion Criteria:

1. 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.
2. Medical contraindication to participation in physical activity
3. Unable to communicate in either Spanish or English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Text Messaging; Weekly text message invitations over 4 weeks to engage in physical activity counseling	Behavioral: Text Messaging; 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.
Experimental: Text Messaging with Motivational Messages; Weekly text message invitations over 4 weeks to engage in physical activity counseling that also include motivational messages	Behavioral: Text Messaging; 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.; Behavioral: Motivational Messaging; 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.
Active Comparator: PA Counseling and Self-Directed Walk with Ease; Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management.	Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease; 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.
Experimental: PA Counseling and Enhanced, Self-Directed Walk with Ease; Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management along with opportunity to participate in group classes.	Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease; 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.; Behavioral: Enhanced Walk with Ease; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-Enroll for PA Counseling	Number of persons enrolling in PA counseling divided by the total number of persons eligible for enrollment	From time of initiating text messaging to enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEG-3	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	Baseline, 6, 12 and 26 weeks
PROMIS Physical Function	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).	Baseline, 6, 12 and 26 weeks
PROMIS Sleep Disturbance	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).	Baseline, 6, 12 and 26 weeks
PROMIS Depression	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).	Baseline, 6, 12 and 26 weeks
Sleep Duration	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	Baseline, 6, 12 and 26 weeks
Pain Self-Efficacy	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.	Baseline, 6, 12 and 26 weeks
High Impact Chronic Pain	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.	6, 12 and 26 weeks
Physical Activity	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	Baseline, 6, 12 and 26 weeks
Global Impression of Change	Participants are asked their overall level of satisfaction with treatment with responses on a likert scale.	6, 12 and 26 weeks
Health care utilization	Self-reported utilization of surgery, injections, imaging or other discrete interventions for pain associated with arthritis	6, 12 and 26 weeks

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; osteoarthritis; self-management; physical therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Osteoarthritis; Chronic Pain; methyl hydroxyethyl cellulose
• Other Study ID Numbers: 00182708; 1U48DP006833 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified data in a data repository
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No