Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-09-07
Brief Title:
A Pilot Study for Adaptation of Neospot Device for Health Care at Primary Health Facilities in Kenya
Sponsor:
Neopenda PBC
Organization:
Neopenda PBC
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None