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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04538157
Registration number
NCT04538157
Ethics application status
Date submitted
6/08/2020
Date registered
3/09/2020
Date last updated
10/05/2024
Titles & IDs
Public title
Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
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Scientific title
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
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Secondary ID [1]
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AKTN 20.01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Frailty
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Chronic Kidney Diseases
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Comprehensive Geriatric Assessment
Experimental: 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.
No Intervention: Usual Care - Usual Care
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Goal Attainment Scaling at 3 months
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Assessment method [1]
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To determine whether CGA in frail older people with stages 3-5 CKD improves attainment of patients' own goals of care at three months.
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Goal Attainment Scaling at 6 and 12 months
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Assessment method [1]
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To determine whether CGA improves attainments of patients' own goals of care at six and 12 months.
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Timepoint [1]
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6 and 12 months
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Secondary outcome [2]
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Quality of life using EQ-5D-5L
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Assessment method [2]
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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
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Timepoint [2]
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3, 6 and 12 months
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Secondary outcome [3]
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Frailty status
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Assessment method [3]
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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.
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Timepoint [3]
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3, 6 and 12 months
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Secondary outcome [4]
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Mortality
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Assessment method [4]
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To determine whether CGA reduces mortality during the 12 months follow-up.
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Duration of hospital admissions
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Assessment method [5]
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To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up.
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Number of hospital admissions
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Assessment method [6]
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To determine whether CGA reduces the number of hospital admissions during the 12 months follow-up.
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Number of residential aged care facility admissions
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Assessment method [7]
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To determine whether CGA reduces admissions to residential aged care facilities at 12 months follow-up.
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Cost-effectiveness
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Assessment method [8]
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Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms
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Timepoint [8]
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12 months
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Eligibility
Key inclusion criteria
Inclusion Criteria for screening:
- Moderate to severe CKD as determined by the treating nephrologist:
- 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)
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Estimated life expectancy of less than 12 months.
- Unable to provide informed consent and/or participate in the Goal Attainment Scaling
process due to cognitive impairment or another reason.
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
240
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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Renal Research Gosford - Gosford
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Recruitment hospital [4]
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Liverpool Hospital - Liverpool
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Recruitment hospital [5]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [6]
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Cairns Hospital - Cairns
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Recruitment hospital [7]
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Logan Hospital - Logan
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Recruitment hospital [8]
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Gold Coast Hospital - Southport
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Recruitment hospital [9]
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Toowoomba Hospital - Toowoomba
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Recruitment hospital [10]
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Townsville Hospital - Townsville
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Recruitment hospital [11]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [12]
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Austin Health - Heidelberg
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Recruitment hospital [13]
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Western Health - St Albans
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Recruitment hospital [14]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [15]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2250 - Gosford
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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4102 - Brisbane
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Recruitment postcode(s) [6]
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4870 - Cairns
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Recruitment postcode(s) [7]
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4138 - Logan
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Recruitment postcode(s) [8]
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- Southport
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Recruitment postcode(s) [9]
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4350 - Toowoomba
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Recruitment postcode(s) [10]
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- Townsville
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Recruitment postcode(s) [11]
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5000 - Adelaide
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Recruitment postcode(s) [12]
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3084 - Heidelberg
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Recruitment postcode(s) [13]
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3021 - St Albans
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Recruitment postcode(s) [14]
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6009 - Nedlands
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Recruitment postcode(s) [15]
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- Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04538157
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Ruth Hubbard
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04538157
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