The Beat Pain Better Trial

Phase 3

Not yet recruiting

• Conditions: Osteoarthritis; Chronic Pain Management

• Registration Number: NCT06932887
• Lead Sponsor: University of Utah

Brief Summary

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.

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-05-15
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 346

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reach-Enroll for PA Counseling	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States