User-Centered Development of an App-Based Cognitive-Behavioral Intervention to Reduce Persistent Opioid Use and Opioid Related Problems Following Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Usability
研究概览
简要总结
SpinePal is a self-guided digital intervention developed for patients undergoing spine surgery. The goal of this study is to learn if SpinePal is acceptable to people undergoing spine surgery. The main questions the investigators aim to answer are:
- Is the SpinePal platform considered usable and acceptable by people undergoing spine surgery?
- Is the SpinePal intervention feasible among people undergoing spine surgery?
Participants will:
- Take a screening questionnaire
- Engage with SpinePal for about 2 weeks before surgery and 4 weeks after surgery
- Wear a smartwatch
- Complete questionnaires about 4 weeks after surgery
- Complete a brief virtual interview to share feedback with the study team
详细描述
SpinePal will be piloted in a sample of N = 10 patients who are scheduled to undergo lumbar or cervical spine surgery. A pre-surgery enrollment visit will occur via Zoom at least 2 weeks prior to the patient's surgery. Prior to the visit, the participant will complete screening and baseline measures. The research coordinator will then provide instructions for accessing SpinePal, including a unique user ID and password assigned to the participant. During the enrollment visit, participants will also be provided with instructions for completing physiological monitoring via a wrist-worn Garmin Vivosmart 5. The Garmin will be used to passively collect data on physiological arousal (i.e., heart rate variability), physical activity, and sleep throughout the open pilot. To enable collecting this Garmin data, the research coordinator will also assist participants with downloading and logging into a Labfront account on their smartphone.
Participants will be instructed to use SpinePal for 2-4 weeks leading up to surgery, and for at least 1 month after surgery. Participants will receive daily reminders via push notifications delivered to their smartphone. SpinePal will collect background app usage data to assess adherence and track usage of specific tools.
At 1-month postoperative, participants will receive a link to a REDCap survey including the System Usability Scale (SUS) and Client Satisfaction Questionnaire (CSQ-8), which will serve as the primary outcomes in combination with adherence based on app meta-data. Participants will also repeat surveys conducted preoperatively. The participant will then complete a 30-minute semi-structured exit interview with the research coordinator to gather additional feedback on the intervention framework, platform, content, and procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •English-speaking
- •Able and willing to provide informed consent
- •Scheduled for lumbar or cervical fusion surgery at least 2 weeks from the date of enrollment
- •Owns a smartphone with reliable internet and/or data access
- •Willing to engage with SpinePal and physiological monitoring via wrist-worn Garmin
排除标准
- •Undergoing surgery for infection, malignancy, or trauma
- •Undergoing isolated thoracic fusion
- •Undergoing another major surgery within 3 months
- •Active suicidal ideation and/or severe mental illness (e.g., psychosis)
研究组 & 干预措施
SpinePal
Participants will have access to SpinePal from 2 weeks before surgery through 4 weeks after surgery. Participants can use SpinePal as much or as little as they want.
干预措施: SpinePal (Device)
结局指标
主要结局
Usability
时间窗: Enrollment to the end of treatment at 1 month post-surgery
Usability is measured by participant responses on the System Usability Scale (SUS). The SUS score will range from 0 to 100, where higher scores indicate better usability.
Acceptability
时间窗: Enrollment to the end of treatment at 1 month post-surgery
Intervention acceptability is measured by participant responses on the Client Satisfaction Questionnaire-8 (CSQ-8).
Feasibility
时间窗: Enrollment to 1 month post-surgery
Feasibility will be assessed via app meta-data. Engagement rates will be quantified based on the frequency and duration of interactions with the application during the clinical trial period.
次要结局
未报告次要终点
研究者
Madelyn R. Frumkin
Assistant Professor
Trustees of Dartmouth College