Improving Health for Older Adults With Pain Through Engagement

Официальное название

Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study

Обзор

The goal of this project is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of a 10-week mind-body and walking program (GetActive+) vs treatment as usual (TAU). The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline (0 weeks), post-intervention (1 week after intervention completion), and 6-month follow-up. This study will receive support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).

Подробное описание

The aim of this phase is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of GetActive+ vs TAU on the following outcomes.

Aim 1: Self-reported physical function at 10 weeks (primary). Aim 2: Self-reported physical function at 6 months, performance based (6-minute walk test), and objective (step-count) physical function, as well as self-reported emotional function, pain, social support and loneliness at 10 weeks and 6 months.

Aim 3: Feasibility, acceptability, fidelity and adoption at patient, provider, and organization levels based on Proctor's implementation framework.

The investigators will enroll N=200 older adults with chronic pain from Revere HealthCare Center and MGH Broadway Primary Care in Revere. The GetActive+ program used in the Randomized Controlled Trial (RCT) will incorporate mind-body skills, cognitive behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance based and objective (step count) physical function. This program will teach participants four core skills: 1) weekly goal setting for gradual increase in time spent walking paired with activities of daily living that are meaningful and important to participants (i.e. walk instead of drive to the store; walk to the park with kids); 2) quota-based pacing (increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., diaphragmatic breathing to manage intense pain flares and pain anxiety; progressive muscle relaxation to increase body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the transience of pain and change one's relationship with it; self-compassion when falling short of set goals); and 4) understand the downward spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or unhelpful pain-related thoughts that interfere with meeting program goals. Participants will be encouraged to complete their homework (logs for mind-body practice, physical activities) each day. Participants will be given the option to receive homework and session reminders via text messages from study staff. This between-session contact will focus on increasing treatment adherence, maintaining engagement, and session reminders. The investigators will run groups primarily in English with additional groups in Spanish.

Baseline assessments, post-intervention assessments and 6-month follow up assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness while accounting for clinical, demographic, and social determinants of health.

Вмешательства

• Поведенческое GetActive+
  This is a 10-week group mind body program focused on improving self-reported physical activity, performance-based physical activity, and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increase in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.

Первичные конечные точки

• Physical function - self-report [Срок оценки: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.]

Вторичные конечные точки (7)

• Physical function - objective [Срок оценки: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)]
• Physical function - performance-based [Срок оценки: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)]
• Pain Intensity and Severity [Срок оценки: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)]
• Pain Intensity and Interference [Срок оценки: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)]
• Depression [Срок оценки: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)]
• Anxiety [Срок оценки: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)]
• Impression of Change [Срок оценки: Post-Intervention]

Критерии участия

Критерии включения

• Older Adults (i.e., age >=55)
• Diagnosed musculoskeletal chronic pain of any type (e.g., pain > 3 months)
• Pain score >=4 (moderate) on the Numerical Rating Scale
• Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., <4 errors)
• Self-reported ability to complete the 6-minute walk test including with assistive devices
• Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff
• English or Spanish fluency and literacy

Критерии исключения

• Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)
• Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch
• Active suicidal ideation with plan or intent
• Active and untreated serious mental health or substance use disorder

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Публикации

• Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19. PMID 33469845
• Grunberg VA, Greenberg J, Mace RA, Bakhshaie J, Choi KW, Vranceanu AM. Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. J Pain. 2022 Nov;23(11):1933-1944. doi: 10.1016/j.jpain.2022.07.003. Epub 2022 Jul 29. PMID 35914640
• Popok PJ, Greenberg J, Gates MV, Vranceanu AM. A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Complement Ther Clin Pract. 2021 Aug;44:101410. doi: 10.1016/j.ctcp.2021.101410. Epub 2021 May 2. PMID 33971485
• Vonderheide C, Kilduff C, McDermott KA, Greenberg J, La Camera DE, Giraldo-Santiago N, Kurkul A, Alvarez-Frank N, Kim Y, Pasinski R, Gholston M; iHOPE Study Team; Ritchie CS, Vranceanu AM. Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study. Contemp Clin Trials. 2025 Dec; PMID 41326265

Идентификаторы

NCT: NCT06119698 · 2024P000782

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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