Feasibility of Using NeoSpot at Community Settings

Pregnancy Related Clinical Trial

Official title:

Feasibility of Vital Sign Assessment by Community Health Workers During Antenatal Care Community Outreach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652777
• Other study ID #: 3109-2022
• Status: Recruiting
• Start date: January 15, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Centre for Infectious Disease Research in Zambia
• Contact: Albert Manasyan, MD, MPH
• Phone: 00260211242257
• Email: Albert.Manasyan[@]cidrz.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria

1. Pregnant

2. 18+ years of age

3. Willing to consent

Exclusion criteria

1. Unable to consent

2. Not pregnant

3. Age below 18 years

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Device:
• NeoSpot
Pregnant women will undergo screening of their vital signs using the NeoSpot device.

Locations

Country	Name	City	State
Zambia	Kanyama First Level Hospital	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Infectious Disease Research in Zambia	Neopenda, PBC, Wellcome Trust

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using a wearable, wireless vital sign monitoring solution NeoSpot device by Community Health Workers (CHWs)	To describe the feasibility of CHWs to use the NeoSpot device during community ANC outreach through in-depth interviews	Baseline to day 1
Primary	Acceptability of using a wearable, wireless vital sign monitoring solution NeoSpot device by Community Health Workers (CHWs)	To describe the acceptability of CHWs to use the NeoSpot device during community ANC outreach through in-depth interviews	Baseline to day 1
Secondary	Acceptability of using a wearable, wireless vital sign monitoring solution NeoSpot device by pregnant women	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
Secondary	Collect photoplethysmograph (PPG) data using a wearable, wireless vital sign monitoring solution NeoSpot device	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