The Beat Pain Better Trial

Официальное название

Mountain West Arthritis Secondary Prevention Program - The Beat Pain Better Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Reach-Enroll for PA Counseling [Срок оценки: From time of initiating text messaging to enrollment]

Вторичные конечные точки (10)

• PEG-3 [Срок оценки: Baseline, 6, 12 and 26 weeks]
• PROMIS Physical Function [Срок оценки: Baseline, 6, 12 and 26 weeks]
• PROMIS Sleep Disturbance [Срок оценки: Baseline, 6, 12 and 26 weeks]
• PROMIS Depression [Срок оценки: Baseline, 6, 12 and 26 weeks]
• Sleep Duration [Срок оценки: Baseline, 6, 12 and 26 weeks]
• Pain Self-Efficacy [Срок оценки: Baseline, 6, 12 and 26 weeks]
• High Impact Chronic Pain [Срок оценки: 6, 12 and 26 weeks]
• Physical Activity [Срок оценки: Baseline, 6, 12 and 26 weeks]
• Global Impression of Change [Срок оценки: 6, 12 and 26 weeks]
• Health care utilization [Срок оценки: 6, 12 and 26 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of Utah — Salt Lake City
• Association for Utah Community Health — Salt Lake City
• Vamos Health — West Valley City

Идентификаторы

NCT: NCT06932887 · 00182708 · 1U48DP006833

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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