Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Numerical Pain Score (NPS)
研究概览
简要总结
This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.
详细描述
This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT.
The WHT will consist of:
- AppleWatch and iPhone
- Patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph)
- Prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training
Subjects will use the WHT 20 hours per day, every day for a period of 12 months.
Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Admission to the MPP
- •Completion of the 3-day MPP training
- •Ability to understand and complete the informed consent form prior to the initiation of any study procedures
- •Adequate motor skills needed to utilize WHT
- •Willingness to utilize personal electronic devices and WHT, as expressed and documented during the informed consenting process
- •Ability to understand spoken and written English
排除标准
- •Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease
- •Hospitalization >30 days during the 12 months prior to Index Date
- •Nursing home or hospice care during the 12 months prior to Index Date
- •Presence of an EHR Diagnosis description "OPT-OUT CENTER RESEARCH" which indicates the subject has opted out of (i.e., does not wish to be included in) any Geisinger retrospective research
- •Has a terminated Medicine Use Agreement on their Problem List, indicator for substance abuse/dependence
结局指标
主要结局
Numerical Pain Score (NPS)
时间窗: Baseline, 12-month follow-up
self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).
Patient Health Questionnaire (PHQ-9)
时间窗: Baseline, 12-month follow-up
self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Mean Daily Morphine Equivalents (MEQs)
时间窗: Baseline, 12-month follow-up
calculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].
次要结局
- Oswestry Disability Index (ODI)(Baseline, 12-month follow-up)