FrailtyNCT04538157
Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
A study testing Comprehensive Geriatric Assessment in people with Frailty and Chronic Kidney Diseases, run by The University of Queensland at 15 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frailty, Chronic Kidney Diseases
- What is being tested?
- Comprehensive Geriatric Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 15 sitesAustralia
- Study dates
- 15 Mar 2021to 19 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Australia15 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Blacktown Hospital
Blacktown, New South Wales, 2148
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Cairns Hospital
Cairns, Queensland, 4870
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Renal Research Gosford
Gosford, New South Wales, 2250
Austin Health
Heidelberg, Victoria, 3084
Liverpool Hospital
Liverpool, New South Wales, 2170
Logan Hospital
Logan City, Queensland, 4138
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Perth Hospital
Perth, Western Australia
Gold Coast Hospital
Southport, Queensland
Western Health
St Albans, Victoria, 3021
Toowoomba Hospital
Toowoomba, Queensland, 4350
Townsville Hospital
Townsville, Queensland
About this study
Official 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
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).
Read the detailed description
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.
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
- Frailty, Chronic Kidney Diseases
- Being tested
- Comprehensive Geriatric Assessment
- Keywords
- Goal Attainment Scaling, Frailty Index
- Medical subject headings
- Frailty, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
Also called CGA
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Geriatric Assessment | Experimental | 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. Receives: Other: Comprehensive Geriatric Assessment |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling at 3 months
To determine whether CGA in frail older people with stages 3-5 CKD improves attainment of patients' own goals of care at three months.
Measured: 3 months
Secondary outcomes (8)
Goal Attainment Scaling at 6 and 12 months
To determine whether CGA improves attainments of patients' own goals of care at six and 12 months.
Measured: 6 and 12 months
Quality of life using EQ-5D-5L
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
Measured: 3, 6 and 12 months
Frailty status
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.
Measured: 3, 6 and 12 months
Mortality
To determine whether CGA reduces mortality during the 12 months follow-up.
Measured: 12 months
Duration of hospital admissions
To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up.
Measured: 12 months
Number of hospital admissions
To determine whether CGA reduces the number of hospital admissions during the 12 months follow-up.
Measured: 12 months
Number of residential aged care facility admissions
To determine whether CGA reduces admissions to residential aged care facilities at 12 months follow-up.
Measured: 12 months
Cost-effectiveness
Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start15 Mar 2021
- Primary completion30 Jun 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Ruth Hubbard, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538157
- Sponsor's protocol ID
- AKTN 20.01
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2020
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Logan B, Viecelli AK, Johnson DW, Comans T, Gordon EH, Gray LC, Hawley CM, Hickey LE, Janda M, Jaure A, Jose MD, Kiriwandeniya C, Matsuyama M, Mihala G, Nguyen KH, Pascoe EM, Paul-Brent PA, Pole JD, Polkinghorne KR, Pond CD, Raj R, Reidlinger DM, Scholes-Robertson N, Valks A, Wong G, Hubbard RE; GOAL Trial Investigators. A cluster randomized controlled trial (GOAL trial) evaluated a comprehensive geriatric assessment for frail older people with chronic kidney disease. Kidney Int. 2026 Jun 18:S0085-2538(26)00495-3. doi: 10.1016/j.kint.2026.05.015. Online ahead of print.
PubMed 42315016Mihala 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.
PubMed 40089148Fox 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.
PubMed 39097313Logan 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.
PubMed 37254217
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04538157
- Acronym / sponsor ID
- AKTN 20.01
- Conditions
- Frailty, Chronic Kidney Diseases
- Keywords
- Goal Attainment Scaling, Frailty Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Geriatric Assessment | Experimental | Other: Comprehensive Geriatric AssessmentSpecialist 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. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentAlso: CGAA 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 | Comprehensive Geriatric Assessment |
Primary outcome
Goal Attainment Scaling at 3 months
Time frame: 3 months
To determine whether CGA in frail older people with stages 3-5 CKD improves attainment of patients' own goals of care at three months.
8 secondary outcomes
Goal Attainment Scaling at 6 and 12 months
Time frame: 6 and 12 months
Quality of life using EQ-5D-5L
Time frame: 3, 6 and 12 months
Frailty status
Time frame: 3, 6 and 12 months
Mortality
Time frame: 12 months
Duration of hospital admissions
Time frame: 12 months
Number of hospital admissions
Time frame: 12 months
Number of residential aged care facility admissions
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 42315016Logan B, Viecelli AK, Johnson DW, Comans T, Gordon EH, Gray LC, Hawley CM, Hickey LE, Janda M, Jaure A, Jose MD, Kiriwandeniya C, Matsuyama M, Mihala G, Nguyen KH, Pascoe EM, Paul-Brent PA, Pole JD, Polkinghorne KR, Pond CD, Raj R, Reidlinger DM, Scholes-Robertson N, Valks A, Wong G, Hubbard RE; GOAL Trial Investigators. A cluster randomized controlled trial (GOAL trial) evaluated a comprehensive geriatric assessment for frail older people with chronic kidney disease. Kidney Int. 2026 Jun 18:S0085-2538(26)00495-3. doi: 10.1016/j.kint.2026.05.015. Online ahead of print.
- Derived from this study: PubMed 40089148Mihala 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.
- Derived from this study: PubMed 39097313Fox 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.
- Derived from this study: PubMed 37254217Logan 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Hubbard principal investigator
The University of Queensland
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Geriatric Assessment in people with Frailty and Chronic Kidney Diseases, run by The University of Queensland at 15 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538157, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.