- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03884218
Thermal Imaging in Old and Frail in the Community
A Study to Assess Thermal Comfort of Frail Older People in a Care Home Setting.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- identification of eligible adults via NHS intermediary care- and awaiting care home residency
- expert guidance and collaboration with NHS partners
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sheffield, United Kingdom, S10 2JF
- Sheffield Teaching Hospitals NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Thermal Comfort
Infra red thermal image
|
thermal image using a non-touch, non-ionising, thermal camera system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thermometer
Time Frame: Baseline
|
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
|
|
Thermal Imaging comparison
Time Frame: Baseline
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charmaine Childs, Sheffield Hallam University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH19634
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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