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

A Pilot Study for the Adaptation of Neospot Device for Health Care Among Out-Patients at Primary Health Facilities in Nairobi and Kajiado Counties, Kenya

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Morbidity
• Intervention / Treatment: Device: Neospot vitals measurement

Detailed Description

This study intends to investigate the experiences of both nurses and patients in the use of a specific brand of such a device known as the 'neospot' device in various sub county, health centres in Kenya. The study also aims at finding out whether the device affects the rate and efficiency of how nurses work in these facilities.

The study will apply a cross sectional design, three facilities will be used as the sampling frame two urban facilities from Nairobi County and one peri urban rural facility from Kajiado county. The participants will be selected randomly. Data will be obtained from a total of 159 randomly selected patients, all the nurses who will be on duty will also be included as participants in the study and the team leaders will be interviewed as key informants for qualitative data. Quantitative data will be analysed using SPSS version 24 for descriptive and inferential statistics, NVIVO software will be used to analyse the qualitative data to determine the themes. Study Duration: Data collection, analysis and report writing will take 4 ½ months.

• Study Type: Interventional
• Enrollment (Estimated): 159
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Assumpta S Nantume, MSc; Phone Number: +256755098873; Email: assumpta@neopenda.com
• Study Contact Backup: Name: Sona R Shah, MSc; Phone Number: +19196222478; Email: sona@neopenda.com

Study Locations

• Kenya
  • Nairobi, Kenya, 00100
    • Langata, Kianda 42 and Matasia Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neospot Vitals Measurement; 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; Vitals of participants in the intervention group will be measured using neospot alongside standard of care measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of vitals measurement of Neospot device compared to traditional equipment	We want to validate the accuracy of the Neospot device to measure temperature, SPO2, pulse rate and respiratory rate by comparing similarities and differences to the traditional devices vital signs readings	From enrolment, monitoring, data extraction and analysis over a period of 4 months
Experiences of patients using the Neospot vitals measurement device	Number of patients reporting positive experience with our Neospot device through surveys	From enrolment, monitoring, data extraction and analysis over a period of 4 months
Acceptability of Neospot device by nurses for adoption in health facilities	Number of nurses willingness to adopt the use the Neospot device as their primary vital sign measurement tool post utilization, determined through surveys	From enrolment, monitoring, data extraction and analysis over a period of 4 months
Effects of Neospot vitals measurement device on nurses' workflow	Number of nurses reporting positive impact of the Neospot device on efficiency and improved workflow through surveys	From enrolment, monitoring, data extraction and analysis over a period of 4 months

Collaborators and Investigators

• Sponsor: Neopenda, PBC
• Collaborators: Amref Health Africa
• Investigators: Principal Investigator: Jesse Oyieke, Amref International University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Morbidity; Health; Vitals Measurement
• Other Study ID Numbers: P1339/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No