NCT06932887

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P50-P75 for phase_3

Timeline
24mo left

Started May 2025

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
May 2025Mar 2028

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 28, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

April 10, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

osteoarthritischronic painphysical therapyself-management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • PEG-3

    Baseline, 6, 12 and 26 weeks

  • PROMIS Physical Function

    Baseline, 6, 12 and 26 weeks

  • PROMIS Sleep Disturbance

    Baseline, 6, 12 and 26 weeks

  • PROMIS Depression

    Baseline, 6, 12 and 26 weeks

  • Sleep Duration

    Baseline, 6, 12 and 26 weeks

  • +5 more secondary outcomes

Study Arms (4)

Text Messaging

ACTIVE COMPARATOR

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

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

Behavioral: Text MessagingBehavioral: 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.

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.

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

Interventions

Text MessagingBEHAVIORAL

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 MessagingText Messaging with Motivational Messages

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.

PA Counseling and Enhanced, 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.

PA Counseling and Enhanced, Self-Directed Walk with EasePA Counseling and Self-Directed Walk with Ease

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.

Text Messaging with Motivational Messages

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Utah

Salt Lake City, Utah, 84106, United States

NOT YET RECRUITING

Association for Utah Community Health

Salt Lake City, Utah, 84107, United States

RECRUITING

Vamos Health

West Valley City, Utah, 84120, United States

RECRUITING

MeSH Terms

Conditions

OsteoarthritisChronic Pain

Interventions

methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Julie Fritz, PhD, PT

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

May 28, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

We will share de-identified data in a data repository

Shared Documents
STUDY PROTOCOL, SAP

Locations