Feasibility of Using NeoSpot at Community Settings

NCT05652777 | Completed

• 1 other identifier: 3109-2022
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Pregnancy; Vital signs; Wearable medical devices

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Acceptability of using a wearable, wireless vital sign monitoring solution NeoSpot device by pregnant women

  Baseline to day 1

• Collect photoplethysmograph (PPG) data using a wearable, wireless vital sign monitoring solution NeoSpot device

  Baseline to day 1

Study Arms (1)

Pregnant women

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

Device: NeoSpot

Interventions

NeoSpot DEVICE

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

Also known as: Vital sign measurement

Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Pregnant
• + years of age
• Willing to consent

You may not qualify if:

• 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
• \. 18+ years of age 3. Willing to consent
• Pregnant women not enrolled in the study
• Unable to consent

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• Neopenda, PBC: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Kanyama First Level Hospital

Lusaka, 10101, Zambia

Location

MeSH Terms

Interventions

Vital Signs

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Albert Manasyan, MD

  Center for Infectious Disease Research in Zambia (CIDRZ)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: December 15, 2022
• Study Start: January 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: Following study closure and publication of the main study findings.
• Access Criteria: De-identified study data will be available to other researchers upon reasonable request to the study PI.

Locations

ZA (1)