The Beat Pain Better Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Text Messaging
BehavioralWeekly 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.
Motivational Messaging
BehavioralThe 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.
Physical Activity Counseling and Self-Directed Walk with Ease
BehavioralAll 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.
Enhanced Walk with Ease
BehavioralAlong 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.
Treatment groups
346 Participants
are divided into 4 treatment groupsGroup A: Text MessagingActive comparator 1 intervention
Group B: Text Messaging with Motivational MessagesExperimental treatment 2 interventions
Group C: PA Counseling and Self-Directed Walk with EaseActive comparator 1 intervention
Group D: PA Counseling and Enhanced, Self-Directed Walk with EaseExperimental treatment 2 interventions
Trial outcomes
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
Time frame
From time of initiating text messaging to enrollmentSecondary outcomes
1
PEG-3
The PEG-3 is a self-report measure that includes 3 items evaluating 1) pain severity; and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores ranging from 0-10
Time frame
Baseline, 6, 12 and 26 weeks2
PROMIS Physical Function
The PROMIS short form 6b for physical function is a self-report that uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).
Time frame
Baseline, 6, 12 and 26 weeks3
PROMIS Sleep Disturbance
The PROMIS short form 6a for sleep disturbance is a self-report that uses fixed items from the PROMIS sleep disturbance item bank to provide a T-score with population mean = 50 (sd=10).
Time frame
Baseline, 6, 12 and 26 weeks4
PROMIS Depression
The PROMIS short form 8a for depression is a self-report that uses fixed items from the PROMIS depression item bank to provide a T-score with population mean = 50 (sd=10).
Time frame
Baseline, 6, 12 and 26 weeksSponsors and contacts
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Source ClinicalTrials.gov