Physical and Mental Health Intervention for Black Adults With Knee Osteoarthritis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The aim of this research study is to test the feasibility of a physical and mental health intervention (Positive Minds, Strong Joints or PMSJ) for Black adults with knee osteoarthritis (OA).
详细描述
In this feasibility study, at least 20 and up to 40 Black Adults will be enrolled to receive PMSJ intervention. Participants who will take part in this research study will be in it for about 26 weeks. Participants will receive a one-hour individual session of psychoeducation, mindfulness, and cognitive behavior therapy skills for 10 weeks via a HIPAA-protected zoom video-call or over the telephone. In addition, they will receive a community-based group exercise and pain education program once a week for 10 weeks. Participants will also continue to receive their usual care. Participants will be asked to take surveys at five time points (i.e.) before the start of the 10-week intervention (baseline visit), mid-way through the intervention (week 5), end of the 10-week intervention (post-intervention), 6 weeks after the intervention (week 16) and 12 weeks after the intervention (week 22). Brief surveys will also be completed weekly throughout the study. The surveys will be about pain, function, quality of life, mood, social support, sleep, etc. At baseline and post-intervention visits, all participants will also be asked to wear a small movement sensor on their lower back for 7 days of continuous movement and physical activity monitoring. During both of these 7-day periods, participants will complete a single remote assessment of their walking. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≤ 40 kg/m2
- •Self-identify as Black (including African American)
- •Knee pain ≥4/10 on a 11 numeric scale over the past week
- •Scored 5 or more on either the Patient Health Questionnaire (PHQ-9) and/or the Generalized Anxiety Disorder 7-item Scale (GAD-7)
- •Can speak and understand English at a sufficient level to understand the study procedures and informed consent
- •Available for study duration
- •Able to attend remote sessions
排除标准
- •Knee, hip or ankle replacement
- •Intra-articular corticosteroid or hyaluronic acid knee injection within 3 months
- •Knee surgery within past 6 months
- •Currently receiving or received within 3-months any PT for knee OA
- •Currently receiving or received within 3 months any mental health intervention (excluding pharmacologic treatments)
- •Planning to initiate physical therapy for joint or low back pain in the next 3months
- •Planning to initiate any mental health treatment (excluding pharmacologic treatments) in the next 1 month.
- •Systemic inflammatory arthritis (e.g., rheumatoid arthritis)
- •Neurologic conditions (e.g., stroke, Parkinson's disease, etc.)
- •Contraindications to starting an exercise program.
- •Suspected substance abuse
- •Lack capacity to consent
- •Pregnancy (self-report)
- •Participation in another clinical trial for any joint or muscle pain
- •Planning for a major surgery in the next 6 months
- •Having high risk mental health symptoms (active suicidality, bipolar disorder, mania, psychosis, schizophrenia)
- •Receiving chemotherapy or radiation therapy for cancer (except non-melanoma skin cancer)
研究组 & 干预措施
Positive Minds Strong Joints
Participants will receive an individual mental health intervention and a group-based exercise intervention through a HIPPAA-Protected Zoom videoconferencing once a week for 10 weeks.
干预措施: Positive Minds, Strong Joints (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: Throughout the recruitment process
Number of participants enrolled out of those screened
Retention
时间窗: From the start of the study to end of the 10 week intervention
Proportion of participants who complete patient-reported outcome surveys at 10 week timepoint
Attendance
时间窗: During 10 weeks intervention period
Proportion of participants that attended at least 80% of intervention sessions
Satisfaction with treatment
时间窗: week 10 and week 22
Custom 2-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e., Positive Minds, Strong Joints). There are 2 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.
Participant Feedback
时间窗: week 10 and week 22
Custom survey asking the participants to provide feedback on a 5-point scale from very poor to excellent on various aspects of the intervention including content, interventionists, group aspects, overall rating, etc.
次要结局
- International Physical Activity Questionnaire(Baseline, week 10, week 22)
- Patient-Reported Outcomes Measurement Information System-sleep(Baseline, week 10)
- Patient Global Rating of Change(Week 10, Week 22)
- Knee Injury and Osteoarthritis Outcome Score(Baseline, week 5, week 10, week 16 and week 22)
- Patient Health Questionnaire 9-item(Baseline, week 5, week 10, week 16 and week 22)
- Generalized anxiety 7-item scale(Baseline, week 5, week 10, week 16 and week 22)
- Arthritis Self Efficacy Scale(Baseline, week 10, and week 22)
- Fear Avoidance Beliefs Questionnaire - Physical Activity(Baseline and week 10)
- Pain Catastrophizing Scale(Baseline and week 10)
- Trust in Medical Research Questionnaire(Baseline and week 10)
- Multidimensional Scale of Perceived Social Support(Baseline and week 10)
- Numerical Rating Scale-nominated activity(Weekly from start of intervention to week 22)
- Patient Global Assessment of Osteoarthritis(Weekly start of intervention to week 22)
- Adherence to exercise(Weekly from start of intervention to week 22)
- gait speed(Baseline and week 10)
- Physical Activity Stages of change (short form)(Baseline and week 10)
研究者
Deepak Kumar
Associate Professor
Boston University Charles River Campus