NCT03884218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

March 13, 2019

Last Update Submit

March 20, 2019

Conditions

Keywords

Thermal Comfort

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Thermal Comfort

OTHER

Infra red thermal image

Other: Infra red thermal imaging

Interventions

thermal image using a non-touch, non-ionising, thermal camera system

Thermal Comfort

Eligibility Criteria

Age60 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charmaine Childs

    Sheffield Hallam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 21, 2019

Study Start

March 7, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations