Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
NCT ID: NCT04538157
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2021-03-15
2024-11-19
Brief Summary
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Detailed Description
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The GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers.
The 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.
In 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Comprehensive Geriatric Assessment
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.
Comprehensive Geriatric Assessment
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.
Usual Care
Usual Care
No interventions assigned to this group
Interventions
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Comprehensive Geriatric Assessment
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage 3 = eGFR 30 - 59 ml/min/1.73 m2
* Stage 4 = eGFR 15 - 29 ml/min/1.73 m2
* Stage 5/5D = eGFR below 15 ml/min/1.73m2, including patients receiving dialysis
* Aged ≥65 years, or ≥ 55 years if Aboriginal or Torres Strait Islander
For inclusion in enrolment:
* Frailty Index \>0.25 (FI-CKD tool)
Exclusion Criteria
* Unable to provide informed consent and/or participate in the Goal Attainment Scaling process due to cognitive impairment or another reason.
55 Years
ALL
No
Sponsors
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National Health and Medical Research Council, Australia
OTHER
The University of Queensland
OTHER
Responsible Party
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Principal Investigators
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Ruth Hubbard
Role: PRINCIPAL_INVESTIGATOR
The University of Queensland
Locations
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Blacktown Hospital
Blacktown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Renal Research Gosford
Gosford, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
Logan Hospital
Logan City, Queensland, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
Western Health
St Albans, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Countries
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References
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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.
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.
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.
Other Identifiers
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AKTN 20.01
Identifier Type: -
Identifier Source: org_study_id