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Clinical Trials/NCT06132633
NCT06132633
Not yet recruiting
Not Applicable

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

Neopenda, PBC1 site in 1 country159 target enrollmentDecember 2023
ConditionsMorbidity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbidity
Sponsor
Neopenda, PBC
Enrollment
159
Locations
1
Primary Endpoint
Capability, opportunity and motivation of nurses to use the Neospot device for vital signs measurement
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2023
End Date
April 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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