Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial

NCT04538157 | Completed DMC

• 1 other identifier: AKTN 20.01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 15

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).

Conditions

Frailty; Chronic Kidney Diseases

Keywords

Goal Attainment Scaling; Frailty Index

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (8)

• Goal Attainment Scaling at 6 and 12 months

  6 and 12 months

• Quality of life using EQ-5D-5L

  3, 6 and 12 months

• Frailty status

  3, 6 and 12 months

• Mortality

  12 months

• Duration of hospital admissions

  12 months

Other Outcomes (1)

• Process evaluation

  12 months

Study Arms (2)

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.

Other: Comprehensive Geriatric Assessment

Usual Care

NO INTERVENTION

Usual Care

Interventions

Comprehensive Geriatric Assessment OTHER

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.

Also known as: CGA

Comprehensive Geriatric Assessment

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Frailty Index \>0.25 (FI-CKD tool)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Queensland: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (15)

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Renal Research Gosford

Gosford, New South Wales, 2250, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Cairns Hospital

Cairns, Queensland, 4870, Australia

Location

Logan Hospital

Logan City, Queensland, 4138, Australia

Location

Gold Coast Hospital

Southport, Queensland, Australia

Location

Toowoomba Hospital

Toowoomba, Queensland, 4350, Australia

Location

Townsville Hospital

Townsville, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Western Health

St Albans, Victoria, 3021, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

Related Publications (3)

• 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: 40089148 DERIVED

• 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: 39097313 DERIVED

• 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.

  PMID: 37254217 DERIVED

MeSH Terms

Conditions

Frailty; Renal Insufficiency, Chronic

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ruth Hubbard

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: September 3, 2020
• Study Start: March 15, 2021
• Primary Completion: June 30, 2024
• Study Completion: November 19, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.
• Access Criteria: An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.

Locations

AU (15)