Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-28 @ 8:19 PM
Study NCT ID:
NCT04538157
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Process evaluation', 'timeFrame': '12 months', 'description': 'Qualitative analysis of structured interviews.'}], 'primaryOutcomes': [{'measure': 'Goal Attainment Scaling at 3 months', 'timeFrame': '3 months', 'description': "To determine whether CGA in frail older people with stages 3-5 CKD improves attainment of patients' own goals of care at three months."}], 'secondaryOutcomes': [{'measure': 'Goal Attainment Scaling at 6 and 12 months', 'timeFrame': '6 and 12 months', 'description': "To determine whether CGA improves attainments of patients' own goals of care at six and 12 months."}, {'measure': 'Quality of life using EQ-5D-5L', 'timeFrame': '3, 6 and 12 months', 'description': "To determine whether CGA improved patient's quality of life at three, six and 12 months.Quality of life will be assessed using the EQ-5D-5L"}, {'measure': 'Frailty status', 'timeFrame': '3, 6 and 12 months', 'description': 'To determine whether CGA favourably affects the trajectory of frailty status at three, six and 12 months. Frailty will be assessed using the Frailty Index CKD.'}, {'measure': 'Mortality', 'timeFrame': '12 months', 'description': 'To determine whether CGA reduces mortality during the 12 months follow-up.'}, {'measure': 'Duration of hospital admissions', 'timeFrame': '12 months', 'description': 'To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up.'}, {'measure': 'Number of hospital admissions', 'timeFrame': '12 months', 'description': 'To determine whether CGA reduces the number of hospital admissions during the 12 months follow-up.'}, {'measure': 'Number of residential aged care facility admissions', 'timeFrame': '12 months', 'description': 'To determine whether CGA reduces admissions to residential aged care facilities at 12 months follow-up.'}, {'measure': 'Cost-effectiveness', 'timeFrame': '12 months', 'description': 'Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Goal Attainment Scaling', 'Frailty Index'], 'conditions': ['Frailty', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '40089148', 'type': 'DERIVED', 'citation': 'Mihala G, Hubbard RE, Logan B, Johnson DW, Viecelli AK, Forbes AB. Comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals: Statistical analysis plan for a cluster-randomised controlled trial. Contemp Clin Trials. 2025 May;152:107881. doi: 10.1016/j.cct.2025.107881. Epub 2025 Mar 13.'}, {'pmid': '39097313', 'type': 'DERIVED', 'citation': 'Fox ST, Hubbard R, Valks A, Matsuyama M, Kalaw E, Viecelli A, Aquino EM, Johnson D, Janda M. Protocol for the process evaluation of the GOAL trial: investigating how comprehensive geriatric assessment (CGA) improves patient-centred goal attainment in older adults with chronic kidney disease in the outpatient setting. BMJ Open. 2024 Aug 3;14(8):e076328. doi: 10.1136/bmjopen-2023-076328.'}, {'pmid': '37254217', 'type': 'DERIVED', 'citation': 'Logan B, Viecelli AK, Johnson DW, Aquino EM, Bailey J, Comans TA, Gray LC, Hawley CM, Hickey LE, Janda M, Jaure A, Jose MD, Kalaw E, Kiriwandeniya C, Matsuyama M, Mihala G, Nguyen KH, Pascoe E, Pole JD, Polkinghorne KR, Pond D, Raj R, Reidlinger DM, Scholes-Robertson N, Varghese J, Wong G, Hubbard RE; GOAL Trial Investigators. Study protocol for The GOAL Trial: comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals-a cluster randomised controlled trial. Trials. 2023 May 30;24(1):365. doi: 10.1186/s13063-023-07363-4.'}]}, 'descriptionModule': {'briefSummary': 'The GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. This will be the first study, internationally, to evaluate the clinical and cost effectiveness of Comprehensive Geriatric Assessment (CGA), a highly promising intervention for improving patient-important health outcomes in frail older people with Chronic Kidney Disease (CKD).', 'detailedDescription': 'There is an increasing number of frail patients with CKD, and multiple morbidities. Many of them face rapid deterioration of health, referral to residential aged care facilities and loss of independence. This substantively impairs their quality of life and has societal ramifications, including very high costs of care. Patients and carers are often overwhelmed by the multitude of decisions they have to make and may follow a care path that is in contrast to their goals.\n\nThe GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers.\n\nThe primary objective is to test the hypothesis that in frail older people with stages 3-5 CKD, Comprehensive Geriatric Assessment (compared with usual care) will increase attainment of patient-identified goals at 3 months follow up. The secondary objectives are to test the hypotheses that the Comprehensive Geriatric Assessment will increase attainment of patient-identified goals at 6 and 12 months follow up, improve their quality of life and reduce frailty, hospital and residential aged care facility admissions while being safe and cost-effective.\n\nIn this multicentre cluster randomised controlled trial, a total of 500 adult CKD stage 3-5 patients will be recruited. Sites will be randomly allocated to either provide a Comprehensive Geriatric Assessment to participants or usual care. The primary outcome measure is goal attainment scaling at 3 months follow up. The secondary outcome measures will be goal attainment scaling at 6 and 12 months, quality of life EQ-5D-5L, frailty index, mortality, hospital and residential aged care facility admissions and cost-utility analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for screening:\n\n* Moderate to severe CKD as determined by the treating nephrologist:\n* Stage 3 = eGFR 30 - 59 ml/min/1.73 m2\n* Stage 4 = eGFR 15 - 29 ml/min/1.73 m2\n* Stage 5/5D = eGFR below 15 ml/min/1.73m2, including patients receiving dialysis\n* Aged ≥65 years, or ≥ 55 years if Aboriginal or Torres Strait Islander\n\nFor inclusion in enrolment:\n\n* Frailty Index \\>0.25 (FI-CKD tool)\n\nExclusion Criteria:\n\n* Estimated life expectancy of less than 12 months.\n* Unable to provide informed consent and/or participate in the Goal Attainment Scaling process due to cognitive impairment or another reason.'}, 'identificationModule': {'nctId': 'NCT04538157', 'briefTitle': 'Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial', 'organization': {'class': 'OTHER', 'fullName': 'The University of Queensland'}, 'officialTitle': 'Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease to Increase Attainment of Patient-Identified Goals - A Cluster Randomised Controlled Trial - The GOAL Trial', 'orgStudyIdInfo': {'id': 'AKTN 20.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comprehensive Geriatric Assessment', 'description': 'Specialist co-ordinated care (known as comprehensive geriatric assessment, or CGA) was developed to address medical, social, mental health, and physical needs with the help of a skilled multi-disciplinary team.', 'interventionNames': ['Other: Comprehensive Geriatric Assessment']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual Care'}], 'interventions': [{'name': 'Comprehensive Geriatric Assessment', 'type': 'OTHER', 'otherNames': ['CGA'], 'description': "A CGA is a diagnostic and therapeutic intervention which initially identifies an older person's medical, functional, psychosocial problems and then tailors coordinated management plans to address them.", 'armGroupLabels': ['Comprehensive Geriatric Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Blacktown Hospital', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '2250', 'city': 'Gosford', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Renal Research Gosford', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '4102', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4870', 'city': 'Cairns', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Cairns Hospital', 'geoPoint': {'lat': -16.92366, 'lon': 145.76613}}, {'zip': '4138', 'city': 'Logan City', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Logan Hospital', 'geoPoint': {'lat': -27.63917, 'lon': 153.10944}}, {'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast Hospital', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4350', 'city': 'Toowoomba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Toowoomba Hospital', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}, {'city': 'Townsville', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Townsville Hospital', 'geoPoint': {'lat': -19.26639, 'lon': 146.80569}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '3021', 'city': 'St Albans', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Health', 'geoPoint': {'lat': -37.74496, 'lon': 144.80049}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Ruth Hubbard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': "Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.", 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.', 'accessCriteria': 'An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Queensland', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}