MorbidityNCT06132633
A Pilot Study for Adaptation of Neospot Device for Health Care at Primary Health Facilities in Kenya
A study testing Neospot vitals measurement in people with Morbidity, run by Neopenda, PBC at 1 site in Kenya.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morbidity
- What is being tested?
- Neospot vitals measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteKenya
- Study dates
- Dec 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants between 18 and 70 years of age
- In stable condition
- Willing to give consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Morbidity
- Being tested
- Neospot vitals measurement
- Keywords
- Morbidity, Vitals Measurement, Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neospot vitals measurementDevice
Vitals of participants in the intervention group will be measured using neospot alongside standard of care measurement.
| Study group | Role | What they receive |
|---|---|---|
| Neospot Vitals Measurement | Experimental | 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. Receives: Device: Neospot vitals measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Secondary outcomes (4)
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
Measured: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Experiences of patients using the Neospot vitals measurement device
Number of patients reporting positive experience with our Neospot device through surveys
Measured: From enrolment, monitoring, data extraction and analysis over a period of 4 months
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
Measured: From enrolment, monitoring, data extraction and analysis over a period of 4 months
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
Measured: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a cross-sectional study design. All participants receive the same intervention of our Neospot vitals measurements.
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neopenda, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amref Health Africa
- Responsible party
- Sponsor
- Investigators
- Jesse Oyieke, Principal investigator, Amref International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132633
- Sponsor's protocol ID
- P1339/2023
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06132633
- Acronym / sponsor ID
- P1339/2023
- Conditions
- Morbidity
- Keywords
- Morbidity, Vitals Measurement, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Neopenda, PBCIndustry (pharma, biotech, devices)
- Collaborators
- Amref Health Africa
- Study start
- Dec 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a cross-sectional study design. All participants receive the same intervention of our Neospot vitals measurements.
| Arm | Type | Receives |
|---|---|---|
| Neospot Vitals Measurement | Experimental | Device: Neospot vitals measurementNeospot 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants between 18 and 70 years of age
- In stable condition
- Willing to give consent to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neospot vitals measurementVitals of participants in the intervention group will be measured using neospot alongside standard of care measurement. | Device | Neospot Vitals Measurement |
Primary outcome
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
4 secondary outcomes
Accuracy of vitals measurement of Neospot device compared to traditional equipment
Time frame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Experiences of patients using the Neospot vitals measurement device
Time frame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Acceptability of Neospot device by nurses for adoption in health facilities
Time frame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Effects of Neospot vitals measurement device on nurses' workflow
Time frame: From enrolment, monitoring, data extraction and analysis over a period of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Oyieke principal investigator
Amref International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neospot vitals measurement in people with Morbidity, run by Neopenda, PBC at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assumpta S Nantume, MSc (+256755098873, assumpta@neopenda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.