Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Old Age; Debility Other: Infra red thermal imaging Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Study to Assess Thermal Comfort of Frail Older People in a Care Home Setting.
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Thermal Comfort
Infra red thermal image
 Other: Infra red thermal imaging
thermal image using a non-touch, non-ionising, thermal camera system


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884218


Locations
Layout table for location information
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Investigators
Layout table for investigator information
Principal Investigator: Charmaine Childs Sheffield Hallam University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03884218    
Other Study ID Numbers: STH19634
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Thermal Comfort