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

The University of Queensland

Status: Completed

Conditions: Chronic Kidney Diseases; Frailty

Treatments: Other: Comprehensive Geriatric Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04538157

AKTN 20.01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Comprehensive Geriatric Assessment

Experimental group

Description:

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.

Treatment:

Other: Comprehensive Geriatric Assessment

Usual Care

No Intervention group

Description:

Usual Care