VITAmin and Micronutrient Testing: Acceptability and SCOPE of Point-of-care Device (VITASCOPE)

Evaluation of the Acceptability and Usability of a Point-of-care-in-vitro Diagnostic Micro-sampling Device for Micronutrient Measurement.

Childhood obesity is a global health crisis with 1.2 million children in England severely obese, predisposing them to multiple health risks which decrease lifespan and compromise health. Children suffering from obesity experience a state of paradoxical malnutrition; despite excessive calorie intake they have high rates of micronutrient deficiencies rates due to consumption of energy dense, nutrient poor diets. Around 70-80% of obese children are Vitamin D deficient, 10% have low B12 concentrations and 50% have folic acid deficiency. Currently screening for micronutrient deficiencies does not form a routine part of clinical care at all medical centres because they require a large volume of blood and are expensive to perform. A prototype point-of-care in-vitro diagnostic test has been developed which allows at-home/primary care testing of micronutrient levels, using an integrated finger-prick and minimal amount of blood. This device should be simple to use, with just one push of a button. The results are analysed using a phone app for clear decision-making, with data uploaded to healthcare providers automatically. This study aims to ask service users (young people and their families) for their views on the usability and acceptability of the device prior to developing the product further.

Study Overview

• Status: Completed
• Conditions: Micronutrient Levels

Detailed Description

Malnutrition, where there is an insufficient supply or inability to absorb nutrients is classified by the World Health Organisation as the biggest worldwide threat to public health. Untreated malnutrition is an independent risk factor for mortality and is associated with increased healthcare costs. Malnutrition is not only found in association with low weight but is also found in individuals with morbid obesity. Obese individuals experience a state of paradoxical malnutrition; despite excessive dietary intake they have high micronutrient deficiencies rates due to intake of energy-dense, nutrient-poor diets. Childhood obesity is a global health crisis with 1.2 million children in England severely obese, putting them at multiple health risks which lower lifespan and affect health.

Currently micronutrient measurement is performed in hospitals. A large volume (>6mls) is taken with results for some tests taking a minimum of 2 weeks. This delays treatment starting and requires provision of additional clinical time for the results to be fed back to patients and their families. There are significant financial, emotional and carbon costs for patients attending for hospital based blood tests.

A point-of-care blood test for micronutrients has been developed, which uses an integrated finger-prick and minimal amount of blood (40μls). The device is simple to use, with just one push of a button, allowing primary care clinicians and potentially parents/guardians to administer the test.

This study aims to ask young people and their parents/carers for their views on this device before further development is undertaken on the product to ensure it meets with their needs.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospitals Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

30 children and their parents/carers, attending the Complications of Excess weight (CEW)/ Health Futures Clinic at the Jenny Lind Children's Hospital, NNUH. Parents can participate in the study independently of their children.

Description

Inclusion Criteria:

• Patient aged>10 years or parents of a patient being seen in a NNUH CEW clinic.
• Parents/Participants must have capacity to consent/assent and provide a signed and dated informed consent
• Able to participate in an interview regarding the acceptability/usability of the device.

Exclusion criteria:

- Potential participants will not be eligible if they lack capacity to provide informed consent (or in the case of young people under the age of 16, informed assent and informed parental consent)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants and their parents who prefer using a finger prick test for micronutrient measurement.	What are the preferences of young people and their families regarding the new technology?; To identify the problems and any benefits of the new technology from patients/parents/guardians/ medical staff	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics of study participants	1) Age, gender and ethnicity of participants	12 months

Collaborators and Investigators

• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Collaborators: University of East Anglia
• Investigators: Principal Investigator: Emma Webb, PhD, Consultant at NNUH

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Point-of-care device; micronutrient testing acceptability
• Other Study ID Numbers: Version 1.2 03/06/20; 62431 (Registry Identifier: NIHR Portfolio Study ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No