Clinical trial NCT06132633: A Pilot Study for Adaptation of Neospot Device for Health Care at Primary Health Facilities in Kenya
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Morbidity
Keywords: Morbidity
Vitals Measurement
Health
Lead sponsor: Neopenda, PBC
Sponsor class: INDUSTRY
Collaborators: name: Amref Health Africa
First posted: 2023-11-15
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a cross-sectional study design. All participants receive the same intervention of our Neospot vitals measurements.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Capability, opportunity and motivation of nurses to use the Neospot device for vital signs measurement
timeFrame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Secondary outcomes:
measure: Accuracy of vitals measurement of Neospot device compared to traditional equipment
timeFrame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
measure: Experiences of patients using the Neospot vitals measurement device
timeFrame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
measure: Acceptability of Neospot device by nurses for adoption in health facilities
timeFrame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
measure: Effects of Neospot vitals measurement device on nurses' workflow
timeFrame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Langata, Kianda 42 and Matasia Health Centre
Study officials:
affiliation: Amref International University
name: Jesse Oyieke
role: PRINCIPAL_INVESTIGATOR
References: