Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Physical function - self-report
研究概览
简要总结
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/).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Physical function - self-report
时间窗: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 Physical Functioning Short Form 6b; assesses ability to carry out activities that require physical actions, ranging from self-care to work. Scores range from 6 to 30, with higher scores indicating greater physical function.
Physical function - self-report
时间窗: Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 Physical Functioning Short Form 6b; assesses ability to carry out activities that require physical actions, ranging from self-care to work. Scores range from 6 to 30, with higher scores indicating greater physical function.
次要结局
- Physical function - performance-based(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Physical function - objective(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Depression(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Anxiety(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Pain Intensity and Interference(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Depression(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Anxiety(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Physical function - performance-based(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Physical function - objective(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Pain Intensity and Severity(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Pain Intensity and Interference(Baseline, Post-Intervention, 6-Month Follow Up (~9 months total))
- Impression of Change(Post-Intervention)
研究者
Ana-Maria Vranceanu, PhD
Principal Investigator
Massachusetts General Hospital