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

Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132633
• Other study ID #: P1339/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Neopenda, PBC
• Contact: Assumpta S Nantume, MSc
• Phone: +256755098873
• Email: assumpta[@]neopenda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 159
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbidity

Intervention

Device:
• Neospot vitals measurement
Vitals of participants in the intervention group will be measured using neospot alongside standard of care measurement.

Locations

Country	Name	City	State
Kenya	Langata, Kianda 42 and Matasia Health Centre	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
Neopenda, PBC	Amref Health Africa

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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