Feasibility of Using NeoSpot at Community Settings

NCT ID: NCT05652777

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-04-30

Brief 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.

Detailed 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.

Conditions

Pregnancy Related

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pregnant women

Pregnant women attending antenatal care clinic during routine community outreach activities in Lusaka, Zambia.

NeoSpot

Intervention Type: DEVICE

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

Interventions

NeoSpot

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

Intervention Type: DEVICE

Other Intervention Names

Vital sign measurement

Eligibility Criteria

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

In-depth Interviews:

1. Community Health Workers who have used the NeoSpot device

2. Pregnant women who have experienced the device and enrolled in the study

2. 18+ years of age 3. Willing to consent

1. Pregnant women not enrolled in the study

2. Unable to consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Neopenda, PBC

INDUSTRY

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Manasyan, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Infectious Disease Research in Zambia (CIDRZ)

Locations

Kanyama First Level Hospital

Lusaka, , Zambia

Countries

Zambia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3109-2022

Identifier Type: -

Identifier Source: org_study_id