在社区设置中使用 NeoSpot 的可行性
社区卫生工作者在产前保健社区外展期间进行生命体征评估的可行性
Continuous vital sign monitoring is a basic tenet of specialized care in the developed world that is vastly underutilized during hospital or clinic admissions or outpatient routine visits in most low-and-middle income countries (LMICs). Despite the positive outcomes associated with vital sign monitoring (i.e., increased survival-to-discharge rates, lower complication rates and shorter length of stay in hospital), the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit its practice in the developing world.
Currently, due to lack of medical supplies, most ANC clinics - within the health facilities or during outreach activities - do not monitor for vital signs and blood pressure among pregnant women. While many devices exist, their ease of use and high-cost, including maintenance costs, hinder screening and monitoring programs in low resource settings. Accurate and low-cost vital sign monitoring devices are required to improve identification and treatment of women with danger signs during their routine ANC visits. To meet the growing demand for vital sign monitors during the COVID-19 pandemic, Neopenda has adapted an affordable, wearable, wireless vital sign monitoring solution (neoSpotTM), that measures temperature, respiration rate, blood oxygen saturation, pulse rate, and blood pressure.
研究概览
详细说明
Continuous vital sign monitoring is a basic tenet of specialized care in the developed world that is vastly underutilized during hospital or clinic admissions or outpatient routine visits in most low-and-middle income countries (LMICs). Despite the positive outcomes associated with vital sign monitoring (i.e., increased survival-to-discharge rates, lower complication rates and shorter length of stay in hospital),1 the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit its practice in the developing world.
Wearable health devices (WHDs) are increasingly helping people better monitor their health status both at an activity/fitness level for self-health tracking and at a medical level providing more data to healthcare providers to increase the potential for early diagnosis and guidance of treatment. Key advancements in technology are enabling the creation of smaller computers than ever before; allowing wearable technology to incorporate miniaturized systems to enhance the quality and convenience of patient care.1 Advances in materials science, chemical analysis techniques, equipment design and manufacturing methods have further laid the foundation for the continuous evolution of wearable systems over the years.2
WHDs when properly designed, implemented and adopted can provide ample benefits for healthcare providers and patients. Wearable technologies like Apple watch, Fitbit, Jawbone, ViSi Mobile and Vital Connect wireless patch have been used in tracking personal physiological and biological parameters for routine activity performance and/or clinical monitoring.3,4 These devices collect data such as heart rate, stress levels, obesity, oxygen saturation, blood pressure and calories; and serve a broad range of use cases from newborn to elderly patients in different settings such as hospitals, nursing homes and homecare settings.
Measurement of vital signs in both in- and out-patient departments and during community outreach activities is necessary to assess the clinical situation of the patient and capture early warning scores for deterioration. The currently practice in most LMICs is for a clinician to take routine vital sign measurements intermittently and manually record these on a clinical chart. However, this leaves a lot of room for missed detection of early warning scores. Delays in diagnosing clinical deterioration prevent clinicians from taking corrective actions and are associated with increased complication rates and mortality. The use of wearable devices for long term monitoring is intended to provide instant diagnosis of acute events that will in turn lead to more effective and timely treatment of patients.5 Furthermore, the situation becomes more dire during community outreach activities (i.e., child health week, community ANC outreach, etc.), which are usually conducted by limited clinicians and several community health workers (CHWs).
In contrast to the traditional monitoring devices that have been in use in clinical settings, WHDs may be more suited to the constraints of low-resources settings. Conventional medical equipment frequently fail in health facilities in LMICs due to complex design and specifications, and environmental constraints including power instability, internet access, space limitations and availability of spare parts. This calls upon the need for more feasible innovations to improve on the quality of care for people living in LMICs. WHDs offer a promising solution.
Currently, due to lack of medical supplies, most ANC clinics - within the health facilities or during outreach activities - do not monitor for vital signs and blood pressure among pregnant women. While many devices exist, their ease of use and high-cost, including maintenance costs, hinder screening and monitoring programs in low resource settings. Accurate and low-cost vital sign monitoring devices are required to improve identification and treatment of women with danger signs during their routine ANC visits. To meet the growing demand for vital sign monitors during the COVID-19 pandemic, Neopenda has adapted an affordable, wearable, wireless vital sign monitoring solution (neoSpotTM), that measures temperature, respiration rate, blood oxygen saturation, pulse rate, and blood pressure.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
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Lusaka Province
-
Lusaka、Lusaka Province、赞比亚、10101
- Kanyama First Level Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Pregnant women residing at Kanyama compound and attending ANC care during routine community outreach activities will be approached, screened, and consented for study participation.
Community Health Workers who have used the device on enrolled study participants (pregnant women) will under-go in-depth interviews.
描述
Pregnant women:
Inclusion criteria
- Pregnant
- 18+ years of age
- Willing to consent
Exclusion criteria
- Unable to consent
- Not pregnant
- Age below 18 years
In-depth Interviews:
- Community Health Workers who have used the NeoSpot device
- Pregnant women who have experienced the device and enrolled in the study
2. 18+ years of age 3. Willing to consent
Exclusion criteria
- Pregnant women not enrolled in the study
- Unable to consent
学习计划
研究是如何设计的?
设计细节
- 观测模型:CASE_ONLY
- 时间观点:CROSS_SECTIONAL
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Pregnant women
Pregnant women attending antenatal care clinic during routine community outreach activities in Lusaka, Zambia. |
Pregnant women will undergo screening of their vital signs using the NeoSpot device.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of using a wearable, wireless vital sign monitoring solution NeoSpot device by Community Health Workers (CHWs)
大体时间:Baseline to day 1
|
To describe the feasibility of CHWs to use the NeoSpot device during community ANC outreach through in-depth interviews |
Baseline to day 1
|
|
Acceptability of using a wearable, wireless vital sign monitoring solution NeoSpot device by Community Health Workers (CHWs)
大体时间:Baseline to day 1
|
To describe the acceptability of CHWs to use the NeoSpot device during community ANC outreach through in-depth interviews |
Baseline to day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acceptability of using a wearable, wireless vital sign monitoring solution NeoSpot device by pregnant women
大体时间:Baseline to day 1
|
To describe the acceptability of pregnant women to be screened using the NeoSpot device during community ANC outreach through in-depth interviews |
Baseline to day 1
|
|
Collect photoplethysmograph (PPG) data using a wearable, wireless vital sign monitoring solution NeoSpot device
大体时间:Baseline to day 1
|
To obtain raw PPG data from the prototype NeoSpot device which will be used in the development of an accurate and reliable blood pressure algorithm. |
Baseline to day 1
|
合作者和调查者
合作者
调查人员
- 首席研究员:Albert Manasyan, MD、Center for Infectious Disease Research in Zambia (CIDRZ)
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
De-identified study data will be available to other researchers upon reasonable request to the study PI.
IPD 共享时间框架
Following study closure and publication of the main study findings.
IPD 共享访问标准
De-identified study data will be available to other researchers upon reasonable request to the study PI.
IPD 共享支持信息类型
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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