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Thermal Imaging in Old and Frail in the Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884218
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Sheffield Hallam University
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE March 7, 2017
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thermal Imaging in Old and Frail in the Community
Official Title  ICMJE A Study to Assess Thermal Comfort of Frail Older People in a Care Home Setting.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Old Age; Debility
Intervention  ICMJE Other: Infra red thermal imaging
thermal image using a non-touch, non-ionising, thermal camera system
Study Arms  ICMJE Thermal Comfort
Infra red thermal image
Intervention: Other: Infra red thermal imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2019)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 105 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03884218
Other Study ID Numbers  ICMJE STH19634
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Sheffield Hallam University
Investigators  ICMJE
Principal Investigator: Charmaine Childs Sheffield Hallam University
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP