The Beat Pain Better Trial

NCT ID: NCT06932887

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2028-03-31

Brief Summary

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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

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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

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Osteoarthritis Chronic Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Text Messaging

Weekly text message invitations over 4 weeks to engage in physical activity counseling

Group Type ACTIVE_COMPARATOR

Text Messaging

Intervention Type 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.

Text Messaging with Motivational Messages

Weekly text message invitations over 4 weeks to engage in physical activity counseling that also include motivational messages

Group Type EXPERIMENTAL

Text Messaging

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Physical Activity Counseling and Self-Directed Walk with Ease

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Physical Activity Counseling and Self-Directed Walk with Ease

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Julie Fritz

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status NOT_YET_RECRUITING

Association for Utah Community Health

Salt Lake City, Utah, United States

Site Status RECRUITING

Vamos Health

West Valley City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julie Fritz, PhD, PT

Role: CONTACT

801-587-2237

Facility Contacts

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Julie Fritz, PhD, PT

Role: primary

8015991346 ext. 801-587-2237

Tracey Siaperas

Role: primary

(801) 974-5522

Other Identifiers

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1U48DP006833

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00182708

Identifier Type: -

Identifier Source: org_study_id

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