Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT03884218
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2019-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thermal Imaging in Old and Frail in the Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thermometer', 'timeFrame': 'Baseline', 'description': 'Body Temp: degrees\n\nwhether 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.'}, {'measure': 'Thermal Imaging comparison', 'timeFrame': 'Baseline', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thermal Comfort'], 'conditions': ['Old Age; Debility']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nThe 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.\n\nThe study aims to establish if TC can be predicted by an independent non-invasive imaging device\n\nExpected achievements are a two-way pathway to health impact:\n\n1. identification of eligible adults via NHS intermediary care- and awaiting care home residency\n2. expert guidance and collaboration with NHS partners\n3. 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCare home residents who are:\n\n* Aged over 60 to a maximum age of 105 years\n* Able to sit comfortably for up to 20 minutes without marked agitation.\n* Ability to understand, read and speak English.\n\nExclusion Criteria:\n\nCare home residents who are/have:\n\n* Severe dementia\n* Unable to hold a conversation\n* Who do not wish to take part in the study\n* Unable to speak or understand English\n* Unable to sit with other residents\n* Who are severely agitated or unsettled'}, 'identificationModule': {'nctId': 'NCT03884218', 'briefTitle': 'Thermal Imaging in Old and Frail in the Community', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'A Study to Assess Thermal Comfort of Frail Older People in a Care Home Setting.', 'orgStudyIdInfo': {'id': 'STH19634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Thermal Comfort', 'description': 'Infra red thermal image', 'interventionNames': ['Other: Infra red thermal imaging']}], 'interventions': [{'name': 'Infra red thermal imaging', 'type': 'OTHER', 'description': 'thermal image using a non-touch, non-ionising, thermal camera system', 'armGroupLabels': ['Thermal Comfort']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2JF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Charmaine Childs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Hallam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sheffield Hallam University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}