Viewing Study NCT03884218


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Study NCT ID: NCT03884218
Status: COMPLETED
Last Update Posted: 2019-03-22
First Post: 2019-03-13
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Thermal Imaging in Old and Frail in the Community
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Organization:

Study Overview

Official Title: A Study to Assess Thermal Comfort of Frail Older People in a Care Home Setting.
Status: COMPLETED
Status Verified Date: 2019-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.
Detailed 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: