Clinical trial NCT06932887: The Beat Pain Better Trial
Official title: Mountain West Arthritis Secondary Prevention Program - The Beat Pain Better Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Osteoarthritis
Chronic Pain Management
Keywords: osteoarthritis
chronic pain
physical therapy
self-management
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 346
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Reach-Enroll for PA Counseling
timeFrame: From time of initiating text messaging to enrollment
Secondary outcomes:
measure: PEG-3
timeFrame: Baseline, 6, 12 and 26 weeks
measure: PROMIS Physical Function
timeFrame: Baseline, 6, 12 and 26 weeks
measure: PROMIS Sleep Disturbance
timeFrame: Baseline, 6, 12 and 26 weeks
measure: PROMIS Depression
timeFrame: Baseline, 6, 12 and 26 weeks
measure: Sleep Duration
timeFrame: Baseline, 6, 12 and 26 weeks
measure: Pain Self-Efficacy
timeFrame: Baseline, 6, 12 and 26 weeks
measure: High Impact Chronic Pain
timeFrame: 6, 12 and 26 weeks
measure: Physical Activity
timeFrame: Baseline, 6, 12 and 26 weeks
measure: Global Impression of Change
timeFrame: 6, 12 and 26 weeks
measure: Health care utilization
timeFrame: 6, 12 and 26 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: