A Pilot Study for Adaptation of Neospot Device for Health Care at Primary Health Facilities in Kenya

NCT06132633 | Unknown

• 1 other identifier: P1339/2023
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Neospot device is a 5-in-1 wearable vital signs monitor designed to measure temperature, blood pressure, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SPO2). We propose to study the experiences of patients and nurses regarding spot measurement of vital signs at the outpatient department in primary care facilities in Kenya. The study aims to investigate the capability, opportunity, and motivation of nurses to use the Neospot device for vital signs measurement in level 3 facilities in Kenya by validating the accuracy of the Neospot and assessing the experience of patients while using the Neospot, the study also aims to assess the experiences of nurses as they use the Neospot and determine how the Neospot affects their workflow.

Conditions

Morbidity

Keywords

Morbidity; Vitals Measurement; Health

Outcome Measures

Primary Outcomes (1)

• Capability, opportunity and motivation of nurses to use the Neospot device for vital signs measurement

  Number of nurses reporting positive experiences and improved workflow as a result of utilizing the neospot product as responded in surveys

  From enrolment, monitoring, data extraction and analysis over a period of 4 months

Secondary Outcomes (4)

• Accuracy of vitals measurement of Neospot device compared to traditional equipment

  From enrolment, monitoring, data extraction and analysis over a period of 4 months

• Experiences of patients using the Neospot vitals measurement device

  From enrolment, monitoring, data extraction and analysis over a period of 4 months

• Acceptability of Neospot device by nurses for adoption in health facilities

  From enrolment, monitoring, data extraction and analysis over a period of 4 months

• Effects of Neospot vitals measurement device on nurses' workflow

  From enrolment, monitoring, data extraction and analysis over a period of 4 months

Study Arms (1)

Neospot Vitals Measurement

EXPERIMENTAL

Neospot is a 5-in-1 wearable vitals measurement device designed to measure temperature, blood pressure, pulse rate, respiratory rate and blood oxygen saturation. For the standard of care vitals measurement, conventional vital signs will be measured using mercury blood pressure cuffs and infrared or mercury thermometers for blood pressure and temperature respectively, pulse oximeter for oxygen saturation and a 1-minute count of heart rate and breathing rate.

Device: Neospot vitals measurement

Interventions

Neospot vitals measurement DEVICE

Vitals of participants in the intervention group will be measured using neospot alongside standard of care measurement.

Neospot Vitals Measurement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants between 18 and 70 years of age
• In stable condition
• Willing to give consent to participate in the study

You may not qualify if:

• Very ill and unstable patients who need emergency care
• Patients with medical conditions that are characterized by rapid changes in vital signs such as thyroid disorders
• Patients who have skin lesions on the forehead where the device is to be fixed

Sponsors & Collaborators

• Neopenda, PBC: lead
• Amref Health Africa: collaborator

Study Sites (1)

Langata, Kianda 42 and Matasia Health Centre

Nairobi, 00100, Kenya

Location

Study Officials

• Jesse Oyieke

  Amref International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assumpta S Nantume, MSc

CONTACT

+256755098873; assumpta@neopenda.com

Sona R Shah, MSc

CONTACT

+19196222478; sona@neopenda.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a cross-sectional study design. All participants receive the same intervention of our Neospot vitals measurements.

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: November 15, 2023
• Study Start: December 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)