Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of Retention
研究概览
简要总结
Chronic back pain is the world's leading cause of disability, with spine surgery being a common yet costly intervention. However, many patients experience suboptimal recovery, with persistent pain and functional limitations contributing to high healthcare utilization and costs. Traditional surgical pathways often overlook the role of mental well-being and patient engagement in recovery. However, research indicates that interventions promoting self-management and stress reduction can lead to improvements in pain, faster recovery, and reduced hospital readmissions.
Evidence shows that preoperative psychosocial factors, such as anxiety and depression, significantly predict post-surgical outcomes, yet structured perioperative support is lacking. To address this gap, Ready Set Recover (RSR), a mobile health (mHealth) intervention, provides education, behavioral strategies, and psychosocial support to enhance surgical preparedness and optimize post-surgical recovery. By addressing both psychological and behavioral factors, RSR has the potential to fill a critical gap in perioperative care. As a scalable digital platform, RSR offers an accessible, cost-effective solution that can be easily integrated into existing surgical care models, reducing the burden on healthcare providers while empowering patients to take an active role in their healing process.
RSR aims to accomplish this by integrating evidence-based components such as cognitive behavioral therapy, mindfulness, gratitude practices, and guided movement to foster patient empowerment and sustainable health practices in the pre- and post-surgical periods. The platform provides patients with a structured and flexible tool to improve self-efficacy, adherence to post-surgical recommendations, and the overall surgical recovery experience.
This study aims to evaluate the feasibility and acceptability of RSR through an explanatory mixed-methods pilot randomized controlled trial (RCT) in patients undergoing medium-to-long segment spinal fusion at Oregon Health & Science University.
Aim 1 assesses feasibility and acceptability by measuring patient engagement, intervention completion rates, and satisfaction.
Aim 2 qualitatively evaluate barriers and facilitators to implementation of RSR within the clinic setting via provider, patient, and clinic stakeholder semi-structured interviews.
Aim 3 establishes a patient community advisory board (CAB) to guide future research and the development of a Phase II Small Business Technology Transfer (STTR) efficacy trial.
Findings from this study will inform the refinement and scalability of RSR as a low-burden, cost-effective solution to improve surgical outcomes. Insights gained from this research may extend beyond spine surgery, informing the development of digital health interventions for other surgical populations, ultimately advancing patient-centered, technology-driven approaches to perioperative care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients deemed candidates for medium-/long-segment spinal fusion
- •Patients who score a > 4 on a 0-10 NRS for the question "How motivated are you to participate in this research study?"
- •At least 18 years of age and not older than 80 at the time of study enrollment •Ability to read and understand English
- •Daily access to the internet via cell phone, tablet, or computer
排除标准
- •Have received epidural steroid injection for low back pain, lumbosacral radiculopathy, or scoliosis in the prior 3 months
- •Have received a surgical intervention for low back pain, lumbosacral radiculopathy, or scoliosis in the previous 6 months
- •Concurrent diagnosis of cancer
- •Cognitive impairment
- •Severe comorbidities (e.g., terminal illness, severe organ failure)
- •Non-elective/emergency surgery in the past
研究组 & 干预措施
Surgery + Standard of Care
Surgery + Standard of care is defined as instrumented spinal fusion with routine perioperative care, including preoperative information, postoperative mobilization, and standard analgesia.
Surgery+RSR
Spinal Fusion + Ready Set Recover. Ready Set Recover is a peri-operative mHealth platform designed to help patients prepare for and recover from surgery. RSR empowers patients to be a self-advocate in their surgical journey, plan appropriately for surgery day, garner support from loved ones, and maintain healthy lifestyle practices including: spending time in nature, mindfulness practices and stress reduction, gratitude practice, and post-surgical mindful movement. These activities encourage intrinsically motivated, sustainable behavior change that supports surgical recovery.
干预措施: Ready Set Recover (Behavioral)
结局指标
主要结局
Feasibility of Retention
时间窗: 30 days post-surgery
Measured using a participant tracking spreadsheet
Adverse Events (AEs)
时间窗: Daily from baseline through end of intervention (30 days post surgery)
The study team will regularly monitor for adverse events via the daily survey. In addition to reporting adverse events to the IRB, the investigators will regularly review adverse events at each study meeting in order to rapidly address these events and to facilitate early recognition of any emerging patterns.
Feasibility of enrollment
时间窗: Data collected during screening and enrollment process
Enrollment Rate: Measured using a participant tracking spreadsheet.
Feasibility of Adherence
时间窗: Daily from baseline through end of intervention (30 days post surgery)
Measured through completion with the RSR daily actions and educational materials.
Acceptability and Accessibility
时间窗: 30- days post surgery
Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire.
次要结局
未报告次要终点
研究者
Dharma Colgan
Senior Research Fellow
National University of Natural Medicine