Thermal Imaging in Old and Frail in the Community | NCT03884218

Studies
Thermal Imaging in Old and Frail in the Community

NCT03884218

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Mar 22, 2019Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Old Age; Debility

Interventions

Infra red thermal imaging

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2017Actual

Primary Completion Date

Oct 1, 2018Actual

Completion Date

Oct 1, 2018Actual

First Submitted Date

Mar 13, 2019

First Submission Date that Met QC Criteria

Mar 20, 2019

First Posted Date

Mar 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2019

Last Update Posted Date

Mar 22, 2019Actual

Name	Class
Sheffield Hallam University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thermal Comfort	Other	Infra red thermal image	Other: Infra red thermal imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infra red thermal imaging	Other	thermal image using a non-touch, non-ionising, thermal camera system	Thermal Comfort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline
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.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

105 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charmaine Childs	Sheffield Hallam University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheffield Teaching Hospitals NHS Foundation Trust		Sheffield		S10 2JF	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided