Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT03394534
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2017-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalisation and Nursing Home Admissions', 'timeFrame': 'at 6 months post intervention', 'description': 'Number of hospital and/or care home admissions during the 6 months period and reported in terms of admitted v. not admitted'}], 'secondaryOutcomes': [{'measure': 'Functional Status', 'timeFrame': 'at baseline and 6 months post intervention', 'description': 'Improve Patient functional ability measured using Functional Independence Measure (FIM) questionnaire total score'}, {'measure': 'Loneliness', 'timeFrame': 'at baseline and 6 months post intervention', 'description': 'Improve overall, emotional, and social loneliness calculated using the De Jong Gierveld Loneliness Scale total score. The scale is used to assess subjective perception of social participation or isolation in elderly adults.'}, {'measure': 'Health related Quality of Life', 'timeFrame': 'at baseline and 6 months post intervention', 'description': 'Change in health related quality of life calculated using the 36-Item Short Form Survey (SF-36). The Sf-36 is patient reported outcome measure with a set of generic quality of life measures including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health subscales.'}, {'measure': 'Number of 999 calls and A+E attendance during the 6 months period', 'timeFrame': 'at 6 months post intervention'}, {'measure': 'Length of time spent on A+E during the 6 months period', 'timeFrame': 'at 6 months post intervention'}, {'measure': 'Length of time stayed in hospital or care home during the 6 months period', 'timeFrame': 'at 6 months post intervention'}, {'measure': 'Therapist and staff time spent on CGA during the 6 months period', 'timeFrame': 'at 6 months post intervention'}, {'measure': 'Number of GP/GP out of office attendance (including calls to GP) during the 6 months period', 'timeFrame': 'at 6 months post intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Comprehensive Geriatric Assessment', 'Frailty', 'electronic Frailty Index', 'eFI', 'Care and Support plan', 'Primary Care'], 'conditions': ['Frailty']}, 'referencesModule': {'references': [{'pmid': '23666405', 'type': 'BACKGROUND', 'citation': 'Edmans J, Bradshaw L, Gladman JR, Franklin M, Berdunov V, Elliott R, Conroy SP. The Identification of Seniors at Risk (ISAR) score to predict clinical outcomes and health service costs in older people discharged from UK acute medical units. Age Ageing. 2013 Nov;42(6):747-53. doi: 10.1093/ageing/aft054. Epub 2013 May 10.'}, {'pmid': '23395245', 'type': 'BACKGROUND', 'citation': 'Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.'}, {'pmid': '26941353', 'type': 'BACKGROUND', 'citation': "Gladman JR, Conroy SP, Ranhoff AH, Gordon AL. New horizons in the implementation and research of comprehensive geriatric assessment: knowing, doing and the 'know-do' gap. Age Ageing. 2016 Mar;45(2):194-200. doi: 10.1093/ageing/afw012."}, {'type': 'BACKGROUND', 'citation': 'Fit for Frailty - Developing, commissioning and managing services for people living with frailty in community settings - a report from the British Geriatrics Society and the Royal College of General Practitioners 2015.'}, {'pmid': '25355618', 'type': 'BACKGROUND', 'citation': 'Clegg A, Rogers L, Young J. Diagnostic test accuracy of simple instruments for identifying frailty in community-dwelling older people: a systematic review. Age Ageing. 2015 Jan;44(1):148-52. doi: 10.1093/ageing/afu157. Epub 2014 Oct 29.'}, {'pmid': '37620760', 'type': 'DERIVED', 'citation': 'Safari R, Jackson J, Boole L. Comprehensive geriatric assessment delivered by advanced nursing practitioners within primary care setting: a mixed-methods pilot feasibility randomised controlled trial. BMC Geriatr. 2023 Aug 24;23(1):513. doi: 10.1186/s12877-023-04218-0.'}]}, 'descriptionModule': {'briefSummary': "The study aims to explore feasibility of implementing a tailored CGA to older adults with frailty and evaluate staff and patients perception of the intervention. In line with this, the objectives of the study are:\n\n1. To assess applicability of finding older adults with frailty using eFI and delivering subsequent CGA and care planning at patients' home\n2. To investigate staff and older adults' perception of CGA programme\n3. To assess the health care resource usage and cost of the CGA programme\n4. To measure key health related outcome domains including function, quality of life, loneliness, pain, falls and mobility."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 to 95 years\n* eFI score \\> 0.12\n\nExclusion Criteria:\n\n* Do not meet criteria for frailty based on Gait speed, timed up and go test and PRISMA questionnaire'}, 'identificationModule': {'nctId': 'NCT03394534', 'briefTitle': 'Comprehensive Geriatric Assessment in Primary Care: A Randomised Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Derby'}, 'officialTitle': "'Comprehensive Geriatric Assessment' for Older Adults With Frailty Within Primary Care Setting: A Randomised Feasibility Trial", 'orgStudyIdInfo': {'id': 'v3.6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGA group', 'interventionNames': ['Other: CGA group']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual'}], 'interventions': [{'name': 'CGA group', 'type': 'OTHER', 'description': 'CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)', 'armGroupLabels': ['CGA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE22 1GB', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'University of Derby', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}], 'overallOfficials': [{'name': 'Reza Safari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Derby'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Derby', 'class': 'OTHER'}, 'collaborators': [{'name': 'Derbyshire Clinical Commissioning Groups', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Reza Safari', 'investigatorAffiliation': 'University of Derby'}}}}