The Beat Pain Better Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Text Messaging, Motivational Messaging, Physical Activity Counseling and Self-Directed Walk with Ease, Enhanced Walk with Ease.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Chronic Pain Management. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mountain West Arthritis Secondary Prevention Program - The Beat Pain Better Trial
Overview
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.
Interventions
- Behavioral 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. - 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. - 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 - 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.
Primary outcome measures
- Reach-Enroll for PA Counseling [Time frame: From time of initiating text messaging to enrollment]
Secondary outcome measures (10)
- PEG-3 [Time frame: Baseline, 6, 12 and 26 weeks]
- PROMIS Physical Function [Time frame: Baseline, 6, 12 and 26 weeks]
- PROMIS Sleep Disturbance [Time frame: Baseline, 6, 12 and 26 weeks]
- PROMIS Depression [Time frame: Baseline, 6, 12 and 26 weeks]
- Sleep Duration [Time frame: Baseline, 6, 12 and 26 weeks]
- Pain Self-Efficacy [Time frame: Baseline, 6, 12 and 26 weeks]
- High Impact Chronic Pain [Time frame: 6, 12 and 26 weeks]
- Physical Activity [Time frame: Baseline, 6, 12 and 26 weeks]
- Global Impression of Change [Time frame: 6, 12 and 26 weeks]
- Health care utilization [Time frame: 6, 12 and 26 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- University of Utah — Salt Lake City
- Association for Utah Community Health — Salt Lake City
- Vamos Health — West Valley City
Identifiers
NCT: NCT06932887 · 00182708 · 1U48DP006833