Mountain West Arthritis Secondary Prevention Program - The Beat Pain Better Trial
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 346
- Locations
- 3
- Primary Endpoint
- Reach-Enroll for PA Counseling
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Text Messaging
Weekly text message invitations over 4 weeks to engage in physical activity counseling
Intervention: Text Messaging (Behavioral)
Text Messaging with Motivational Messages
Weekly text message invitations over 4 weeks to engage in physical activity counseling that also include motivational messages
Intervention: Text Messaging (Behavioral)
Text Messaging with Motivational Messages
Weekly text message invitations over 4 weeks to engage in physical activity counseling that also include motivational messages
Intervention: Motivational Messaging (Behavioral)
PA Counseling and Self-Directed Walk with Ease
Six weeks of weekly telehealth PA counseling provided by a physical therapist plus connection to the Walk with Ease portal for ongoing self-management.
Intervention: Physical Activity Counseling and Self-Directed Walk with Ease (Behavioral)
PA Counseling and Enhanced, Self-Directed Walk with Ease
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.
Intervention: Physical Activity Counseling and Self-Directed Walk with Ease (Behavioral)
PA Counseling and Enhanced, Self-Directed Walk with Ease
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.
Intervention: Enhanced Walk with Ease (Behavioral)
Outcomes
Primary Outcomes
Reach-Enroll for PA Counseling
Time Frame: From time of initiating text messaging to enrollment
Number of persons enrolling in PA counseling divided by the total number of persons eligible for enrollment
Secondary Outcomes
- 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)
- Pain Self-Efficacy(Baseline, 6, 12 and 26 weeks)
- High Impact Chronic Pain(6, 12 and 26 weeks)
- Physical Activity(Baseline, 6, 12 and 26 weeks)
- Global Impression of Change(6, 12 and 26 weeks)
- Health care utilization(6, 12 and 26 weeks)
Investigators
Julie Fritz
Distinguished Professor
University of Utah