Thermal Imaging in Old and Frail in the Community
Primary Purpose
Old Age; Debility
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Infra red thermal imaging
Sponsored by
About this trial
This is an interventional supportive care trial for Old Age; Debility focused on measuring Thermal Comfort
Eligibility Criteria
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
Sites / Locations
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Thermal Comfort
Arm Description
Infra red thermal image
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03884218
First Posted
March 13, 2019
Last Updated
March 20, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University
1. Study Identification
Unique Protocol Identification Number
NCT03884218
Brief Title
Thermal Imaging in Old and Frail in the Community
Official Title
A Study to Assess Thermal Comfort of Frail Older People in a Care Home Setting.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility
Keywords
Thermal Comfort
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermal Comfort
Arm Type
Other
Arm Description
Infra red thermal image
Intervention Type
Other
Intervention Name(s)
Infra red thermal imaging
Intervention Description
thermal image using a non-touch, non-ionising, thermal camera system
Primary Outcome Measure Information:
Title
Thermometer
Description
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.
Time Frame
Baseline
Title
Thermal Imaging comparison
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charmaine Childs
Organizational Affiliation
Sheffield Hallam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Thermal Imaging in Old and Frail in the Community
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