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临床试验/NCT06086028
NCT06086028已完成不适用

LA-CEAL 4.0: Louisiana (LA) Community-Engagement Research Alliance (CEAL): Wearable Sensor Project

Tulane University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Percentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period

研究概览

简要总结

The study seeks to explore the efficacy of biofeedback collected via a wrist worn sensor in helping healthcare workers self-manage symptoms of stress and burnout.

详细描述

A randomized two-group cross over design will be used to test the hypothesis that using real-time biofeedback to present, interpret, and bring attention to information regarding stress levels will increase participants readiness to change in regard to addressing burnout. To test this hypothesis, the investigators will recruit 80 providers from Federally Qualified Health Centers (FQHC) partner sites to participate in a 6-week cross over design. The study includes two feedback periods: (1) 21 days of immediate information: (2) 21 days delayed information period. Participant conditions will be switched on day 22. All participants will be given a wrist worn sensor developed by Biostrap. Biostrap collects biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ Heart Rate Variability (HRV); (4) respiratory rate. Participants will be randomly assigned to one of two groups, and either receive immediate or delayed feedback from the sensor first and will then be crossed-over to receive the opposite type of feedback. While wearing the Biostrap wrist-worn sensor, participants will be asked to complete two daily questions sent via the API. The first question seeks to determine if participants accurately understand their biometric data and will ask "how stressed are you today?" (Scale 1-10). The second question seeks to determine if participants attended to the information regarding their stress level and will ask "did you complete a self-care activity today?" (yes/no). A pre and post assessment will be given before and after completing the six-week wearable protocol. Items will include: (1) 2-item depression screener (Patient Health Questionnaire-revised) (2) 2-item anxiety screener (Generalized Anxiety Disorder Scale- revised) (3) 4-item brief resilient coping scale (4) 22-item burnout assessment (Maslach Burnout Inventory) (5) Self-care/supportive psychosocial programs utilization(e.g., I participate in an employee wellness program through my employer) (yes/no) (6) Basic demographics (e.g., age, sex, race, ethnicity, job category, years in field) (7) Familiarity and self-efficacy using wearable sensors (8) Self- report medication list (pretest only).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18 years.
  • Ability to understand and speak English.
  • Staff at FQHC.
  • Smartphone compatible with the Biostrap sensor and phone application.
  • Attending work during the six week study period.

排除标准

  • Unable or unwilling to give informed consent.
  • Disclosed pregnancy at the start of the study.
  • Pace maker or other device regulation heart rate/rhythm.
  • Previous diagnosis of atrial fibrillation.

结局指标

主要结局

Percentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period

时间窗: 6 weeks

The proportion of days in concordance was calculated based on responses to two questions. The first question seeks to determine if participants accurately understand their biometric data and will ask "how stressed are you today?" (Scale 1-10 a score of 6+ was coded as "high stress"). The second question seeks to determine if participants attended to the information regarding their stress level and will ask "did you complete a self-care activity today?" (yes = 1 /no = 0). Concordance was coded when participants either a) reported a high level of stress and engaged in self-care or b) when participants reported low levels of stress and did not engage in self-care. Percentage of days in concordance was calculated for both 21-day feedback periods (immediate versus delayed).

次要结局

  • Change in Burnout Score From Baseline to Follow-up (Pre/Post Sensor Data Collection)(Baseline - 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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