Addressing the Epidemic of Chronic Pain Among Older Adults in Underserved Communities; The GetActive+ Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention Completion
研究概览
简要总结
The goal of this project is to conduct an open-pilot (N=30) to evaluate the feasibility, acceptability, and fidelity of a mind-body and activity program (GetActive+) with older adults with chronic pain. 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 and post-intervention.
This study received support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).
详细描述
The aim of this phase is to establish feasibility (primary), acceptability, and fidelity of GetActive+ and study procedures in an open pilot (N=30). Deliverables: GetActive+ will be feasible (≥75% agree to participate), acceptable (≥75% of those enrolled will complete 8/10 sessions) and delivered with fidelity (≥75% sessions delivered as intended).
Our patients will be older adults with chronic pain from Revere HealthCare Center.
The GetActive+ program 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; body scan 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 an additional two groups in Spanish.
Baseline assessments and post-intervention assessments will include the six-minute walk test (6MWT), objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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)
- •No self-reported current active, untreated psychotic or substance use disorder that would interfere with participation in the research study
- •Ability to complete the 6-minute walk test under supervision of study staff
- •Patient at Revere HealthCare Center who is cleared for participation by medical staff
- •English or Spanish fluency
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 wear the ActiGraph device
结局指标
主要结局
Feasibility of Intervention Completion
时间窗: 10 weeks
\>=75 of patients approached agree to participate in intervention
Acceptability
时间窗: 10 weeks
\>=75% of enrolled participants complete at least 8/10 sessions
Fidelity of Session Components, As Rated by Clinicians
时间窗: Fidelity, as described above, was assessed periodically throughout the 11 months of the study, and is presented here as the sum total counts of all the high scoring components (again, described above) that were assessed over this 11 month time period.
Clinician raters, with experience in intervention refinement or delivery, randomly selected 20% of all sessions to rate their components for this outcome. All sessions were audio-recorded. The overall number of units analyzed, which is reported below, refers to that 20% of the total number of sessions that were then analyzed for this outcome); the overall number of participants analyzed, which is also reported below, is the total number of participants in this study. Clinician raters used fidelity checklists to guide their ratings of the different session components. A session component was considered delivered as intended if the rater provided a score ≥8 (the scale was 1=poor to 10=outstanding). Reported here are the number of session components with a score ≥8, indicating successful delivery; the percentage of the total analyzed sessions that this represents is also calculated out below. The study benchmark we looked to meet for this fidelity measure was 75%.
次要结局
- Self-Compassion Scale - Short Form (SCS-SF)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Pain Catastrophizing Scale (PCS)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Pain, Enjoyment of Life and General Activity Scale (PEG)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Applied Mindfulness Process Scale (AMPS)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Perceived Stress Scale (PSS-4)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Physical Function - Performance-based(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Physical Function - Objective(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Patient Health Questionnaire-8 (PHQ-8)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Generalized Anxiety Disorder Scale-7 (GAD-7);(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Gratitude Questionnaire (GQ-6)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- PROMIS Physical Function - Short Form 6b v2.0(Baseline (0 weeks), Post-test (1 week after intervention completion))
- The Interpersonal Support Evaluation List (ISEL-12),(Baseline (0 weeks), Post-test (1 week after intervention completion))
- PROMIS Sleep Disturbance - Short Form 6a v1.0(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Everyday Discrimination Scale - Short (EDS-S)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Contrast Avoidance Questionnaire - Shortened (CAQ-S)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Patient Global Impression of Change (PGIC)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Tampa Scale for Kinesiophobia-11 (TSK11)(Baseline (0 weeks), Post-test (1 week after intervention completion))
- UCLA-3 Loneliness Scale(Baseline (0 weeks), Post-test (1 week after intervention completion))
- Measure of Current Status (MOCS)(Baseline (0 weeks), Post-test (1 week after intervention completion))
研究者
Ana-Maria Vranceanu, PhD
Principal Investigator
Massachusetts General Hospital