OsteoarthritisPhase 3NCT06932887
The Beat Pain Better Trial
A Phase 3 study testing Text Messaging, Motivational Messaging and Physical Activity Counseling and Self-Directed Walk with Ease in people with Osteoarthritis and Chronic Pain Management, run by University of Utah at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Chronic Pain Management
- What is being tested?
- Text Messaging, Motivational Messaging and Physical Activity Counseling and Self-Directed Walk with Ease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 May 2025to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84106
Julie Fritz, PhD, PT, 8015991346 ext. 801-587-2237, julie.fritz@utah.edu
- Recruiting
Association for Utah Community Health
Salt Lake City, Utah, 84107
Tracey Siaperas, (801) 974-5522, tracey@auch.org
- Recruiting
Vamos Health
West Valley City, Utah, 84120
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Chronic Pain Management
- Being tested
- Text Messaging, Motivational Messaging, Physical Activity Counseling and Self-Directed Walk with Ease, Enhanced Walk with Ease
- Keywords
- osteoarthritis, chronic pain, physical therapy, self-management
- Medical subject headings
- Osteoarthritis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
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 MessagingBehavioural
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 EaseBehavioural
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 EaseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging | Active comparator | Weekly text message invitations over 4 weeks to engage in physical activity counseling Receives: Behavioral: Text Messaging |
| Text Messaging with Motivational Messages | Experimental | Weekly text message invitations over 4 weeks to engage in physical activity counseling that also include motivational messages Receives: Behavioral: Text Messaging; Behavioral: Motivational Messaging |
| PA Counseling and Self-Directed Walk with Ease | Active comparator | Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management. Receives: Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease |
| PA Counseling and Enhanced, Self-Directed Walk with Ease | Experimental | 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. Receives: Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease; Behavioral: Enhanced Walk with Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach-Enroll for PA Counseling
Number of persons enrolling in PA counseling divided by the total number of persons eligible for enrollment
Measured: From time of initiating text messaging to enrollment
Secondary outcomes (10)
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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6, 12 and 26 weeks
Health care utilization
Self-reported utilization of surgery, injections, imaging or other discrete interventions for pain associated with arthritis
Measured: 6, 12 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start28 May 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial uses a multiple randomization design. There are two randomizations; one to a text messaging strategy. The second randomization for those who enroll is to a Walk with Ease format.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Fritz, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932887
- Sponsor's protocol ID
- 00182708
- Other IDs
- 1U48DP006833
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified data in a data repository
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mountain West Arthritis Secondary Prevention Program - The Beat Pain Better Trial
- ClinicalTrials.gov ID
- NCT06932887
- Acronym / sponsor ID
- 00182708
- Conditions
- Osteoarthritis, Chronic Pain Management
- Keywords
- osteoarthritis, chronic pain, physical therapy, self-management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Apr 2025 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This trial uses a multiple randomization design. There are two randomizations; one to a text messaging strategy. The second randomization for those who enroll is to a Walk with Ease format.
| Arm | Type | Receives |
|---|---|---|
| Text Messaging | Active comparator | Behavioral: Text MessagingWeekly text message invitations over 4 weeks to engage in physical activity counseling |
| Text Messaging with Motivational Messages | Experimental | Behavioral: Text Messaging, Behavioral: Motivational MessagingWeekly text message invitations over 4 weeks to engage in physical activity counseling that also include motivational messages |
| PA Counseling and Self-Directed Walk with Ease | Active comparator | Behavioral: Physical Activity Counseling and Self-Directed Walk with EaseSix weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management. |
| PA Counseling and Enhanced, Self-Directed Walk with Ease | Experimental | Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease, Behavioral: Enhanced Walk with EaseSix 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Text MessagingWeekly 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. | Behavioural | Text Messaging, Text Messaging with Motivational Messages |
| Motivational MessagingThe 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. | Behavioural | Text Messaging with Motivational Messages |
| Physical Activity Counseling and Self-Directed Walk with EaseAll 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. | Behavioural | PA Counseling and Enhanced, Self-Directed Walk with Ease, PA Counseling and Self-Directed Walk with Ease |
| Enhanced Walk with EaseAlong 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. | Behavioural | PA Counseling and Enhanced, Self-Directed Walk with Ease |
Primary outcome
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
10 secondary outcomes
PEG-3
Time frame: Baseline, 6, 12 and 26 weeks
PROMIS Physical Function
Time frame: Baseline, 6, 12 and 26 weeks
PROMIS Sleep Disturbance
Time frame: Baseline, 6, 12 and 26 weeks
PROMIS Depression
Time frame: Baseline, 6, 12 and 26 weeks
Sleep Duration
Time frame: Baseline, 6, 12 and 26 weeks
Pain Self-Efficacy
Time frame: Baseline, 6, 12 and 26 weeks
High Impact Chronic Pain
Time frame: 6, 12 and 26 weeks
Physical Activity
Time frame: Baseline, 6, 12 and 26 weeks
Global Impression of Change
Time frame: 6, 12 and 26 weeks
Health care utilization
Time frame: 6, 12 and 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. We will share de-identified data in a data repository
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Text Messaging, Motivational Messaging and Physical Activity Counseling and Self-Directed Walk with Ease in people with Osteoarthritis and Chronic Pain Management, run by University of Utah at 3 sites 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 3 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: looking for participants now, as of the sponsor's last update on 29 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 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Fritz, PhD, PT (801-587-2237, julie.fritz@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach-Enroll for PA Counseling (time frame: From time of initiating text messaging to enrollment). 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 29 Jan 2026.