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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03884218
Other study ID # STH19634
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2017
Est. completion date October 1, 2018

Study information

Verified date March 2019
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to test whether infrared thermal imaging using a non-touch, non-ionising, thermal camera system is feasible and reliable as an independent technique for thermal comfort assessment in older people and frail older people living in a care home and with or without mild cognitive impairment.


Description:

Thermal comfort (TC) is a complex interaction involving physiological, social, cultural and clothing factors. In hospital and in care homes, health-issues (frailty, dementia, immobility) can affect a person's perception of TC.

In the UK 18,000 care homes provide living-communities for approximately 400,000 people. Many are old/frail and vulnerable to indoor chilling. A quality indicator for a good ''home'' environment is related to TC. However, in multiplyoccupied rooms TC varies between individuals. The challenge in health-assessment is in identifying ''uncomfortable'' residents (too hot/too cold). As TC is a subjective perception; a carer cannot reliably predict TC in another person.

The objectives are to use infra-red thermal imaging (IRTI) to 'see' the body temperature map, to demonstrate prevalence of TC/thermal discomfort, to demonstrate whether there is correspondence/dissociation between TC self-report and IRTI-measured body/extremity (hand) temperature.

The study aims to establish if TC can be predicted by an independent non-invasive imaging device

Expected achievements are a two-way pathway to health impact:

1. identification of eligible adults via NHS intermediary care- and awaiting care home residency

2. expert guidance and collaboration with NHS partners

3. translation of results from community to NHS setting e.g. stoke/aged care medicine for improved thermal care on the hospital wards Longer-term the expected achievement (5-7 years)-working with NHS colleagues and design/product development teams is expected to lead towards a commercialisation pathway.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date October 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 105 Years
Eligibility Inclusion Criteria:

Care home residents who are:

- Aged over 60 to a maximum age of 105 years

- Able to sit comfortably for up to 20 minutes without marked agitation.

- Ability to understand, read and speak English.

Exclusion Criteria:

Care home residents who are/have:

- Severe dementia

- Unable to hold a conversation

- Who do not wish to take part in the study

- Unable to speak or understand English

- Unable to sit with other residents

- Who are severely agitated or unsettled

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Infra red thermal imaging
thermal image using a non-touch, non-ionising, thermal camera system

Locations

Country Name City State
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield

Sponsors (2)

Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thermometer Body Temp: degrees
whether an older persons perceptions about thermal comfort is best predicted by their body temperature from the thermometer in Degrees Centigrade. Their temp will be compared to their self reported thermal comfort.
Baseline
Primary Thermal Imaging comparison whether an older persons perceptions about thermal comfort is best predicted by the image that the thermal camera provides (known as a thermal map) along with the data (temperature values) that can be extracted from the thermal image particularly over the area of interest which in this study is the hands and forearm. The thermal image will be compared to self-reported thermal comfort. Baseline
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