The Beat Pain Better Trial

Utah System of Higher Education (USHE)

Status and phase: Enrolling; Phase 3

Conditions: Chronic Pain Management; Osteoarthritis

Treatments: Behavioral: Enhanced Walk with Ease; Behavioral: Text Messaging; Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease; Behavioral: Motivational Messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06932887

00182708

1U48DP006833 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 346 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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346 participants in 4 patient groups

Text Messaging

Active Comparator group

Description:

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

Treatment:

Behavioral: Text Messaging

Text Messaging with Motivational Messages

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Messaging

Behavioral: Text Messaging

PA Counseling and Self-Directed Walk with Ease

Active Comparator group

Description:

Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management.

Treatment:

Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease

PA Counseling and Enhanced, Self-Directed Walk with Ease

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity Counseling and Self-Directed Walk with Ease

Behavioral: Enhanced Walk with Ease