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

Last updated: December 2, 2024
Sponsor: The University of Queensland
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Comprehensive Geriatric Assessment

Clinical Study ID

NCT04538157
AKTN 20.01
  • Ages > 55
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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)

Exclusion

Exclusion Criteria:

  • Estimated life expectancy of less than 12 months.

  • Unable to provide informed consent and/or participate in the Goal Attainment Scalingprocess due to cognitive impairment or another reason.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Comprehensive Geriatric Assessment
Phase:
Study Start date:
March 15, 2021
Estimated Completion Date:
November 19, 2024

Study 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.

Connect with a study center

  • Blacktown Hospital

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Renal Research Gosford

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Cairns Hospital

    Cairns, Queensland 4870
    Australia

    Site Not Available

  • Logan Hospital

    Logan, Queensland 4138
    Australia

    Site Not Available

  • Gold Coast Hospital

    Southport, Queensland
    Australia

    Site Not Available

  • Toowoomba Hospital

    Toowoomba, Queensland 4350
    Australia

    Site Not Available

  • Townsville Hospital

    Townsville, Queensland
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Western Health

    St Albans, Victoria 3021
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia
    Australia

    Site Not Available

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