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

NCT ID: NCT06132633

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbidity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a cross-sectional study design. All participants receive the same intervention of our Neospot vitals measurements.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Neospot vitals measurement

Intervention Type DEVICE

Vitals of participants in the intervention group will be measured using neospot alongside standard of care measurement.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neospot vitals measurement

Vitals of participants in the intervention group will be measured using neospot alongside standard of care measurement.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amref Health Africa

OTHER

Sponsor Role collaborator

Neopenda, PBC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jesse Oyieke

Role: PRINCIPAL_INVESTIGATOR

Amref International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Langata, Kianda 42 and Matasia Health Centre

Nairobi, , Kenya

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kenya

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Assumpta S Nantume, MSc

Role: CONTACT

+256755098873

Sona R Shah, MSc

Role: CONTACT

+19196222478

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P1339/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The PneumoRator Study
NCT07293299 RECRUITING