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NCT06932887 | RECRUITING | Osteoarthritis

The Beat Pain Better Trial
Sponsor:

University of Utah

Information provided by (Responsible Party):

Julie Fritz

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.

Condition or disease

Osteoarthritis

Chronic Pain Management

Intervention/treatment

Text Messaging

Motivational Messaging

Physical Activity Counseling and Self-Directed Walk with Ease

Enhanced Walk with Ease

Phase

PHASE3

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 Type : INTERVENTIONAL
Estimated Enrollment : 346 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Mountain West Arthritis Secondary Prevention Program - The Beat Pain Better Trial
Actual Study Start Date : 2025-05-28
Estimated Primary Completion Date : 2028-03-31
Estimated Study Completion Date : 2028-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
The Beat Pain Better Trial

Location Details

NCT06932887

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84106

RECRUITING

United States, Utah

Association for Utah Community Health

Salt Lake City, Utah, United States, 84107

RECRUITING

United States, Utah

Let's Health

West Valley City, Utah, United States, 84120