Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access: The TELE-MC Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Pain, Enjoyment, and General Activity Scale (PEG-3)
研究概览
简要总结
The purpose of this study is to explore and compare the effectiveness of in-person versus remote physical therapy (PT) for the treatment of musculoskeletal (MSK) pain within the Military Health System (MHS).
详细描述
This study will explore the effect of remote two-way video conference telehealth physical therapy sessions compared to standard of care in-person physical therapy. Eligible participants will be randomized into one of the 2 treatment arms. Specific aims will compare the effectiveness of physical therapy delivery strategies on the primary outcome of Pain, Enjoyment, and General Activity (PEG-3) Scale, which measures pain interference, and secondary outcomes of PROMIS short forms (mood, physical function, fatigue, sleep disturbance, and prescription medication misuse), patient global impression of change, and pain self-efficacy.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Clinicians and patients cannot be blinded to randomized group assignment. Treatment assignments will be blinded for investigators, assessors, and the lead study statistician. Outcomes assessments will be blinded for investigators, interventionists, and the lead study statistician. Study participants will be blinded to all adherence and fidelity assessments.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-64
- •TRICARE Beneficiary (active duty, retiree, dependent)
- •Health care visit for their MSK condition in the past 6 weeks
- •Diagnosed with an MSK condition that has persisted for at least 2 weeks
- •Has a computer (either smartphone, tablet or laptop), with video and audio capabilities for telehealth, including access to internet
- •Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires
- •Available to attend treatment sessions over the next 2 months
排除标准
- •Surgery for any MSK condition in the past 6 months
- •Currently known to be pregnant
- •Medical contraindication to exercise
- •Currently receiving or scheduled to receive invasive or other nonpharmacologic interventions for any MSK condition (e.g., chiropractic, injections, etc.) with the exception of a physical therapy referral, an issued profile or duty restriction, or other related patient education
- •Anyone separating from the military within 9 months (other than normal military retirement), pending a medical or physical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
- •Signs of serious or systemic pathology that could be responsible for the musculoskeletal pain (i.e. ankylosing spondylitis, rheumatoid arthritis, gout, lupus, vertebral osteomyelitis, or psoriatic arthritis), currently receiving treatment for cancer other than skin cancer or acute fracture (in the last 3 months) of the musculoskeletal region.
结局指标
主要结局
Pain, Enjoyment, and General Activity Scale (PEG-3)
时间窗: 12 Weeks
The PEG-3 measure includes 3 items evaluating 1) pain severity; and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores ranging from 0-10.
次要结局
- PROMIS-29(12 Weeks)
- Pain Self-Efficacy Questionnaire (PSEQ)(12 Weeks)
- Patient Global Assessment of Change (PGIC)(12 Weeks)
- PROMIS Short Form Prescription Pain Medication Misuse(26 Weeks)
- EuroQoL (EQ-5D)(12 Weeks)
研究者
Dan Rhon
Professor
Brooke Army Medical Center