Clinical trial NCT04538157: Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Chronic Kidney Diseases
Keywords: Goal Attainment Scaling
Frailty Index
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2020-09-03
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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.

Primary outcomes:
measure: Goal Attainment Scaling at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Goal Attainment Scaling at 6 and 12 months
timeFrame: 6 and 12 months
measure: Quality of life using EQ-5D-5L
timeFrame: 3, 6 and 12 months
measure: Frailty status
timeFrame: 3, 6 and 12 months
measure: Mortality
timeFrame: 12 months
measure: Duration of hospital admissions
timeFrame: 12 months
measure: Number of hospital admissions
timeFrame: 12 months
measure: Number of residential aged care facility admissions
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
measure: Process evaluation
timeFrame: 12 months
Locations:
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Gosford
country: Australia
facility: Renal Research Gosford
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Logan
country: Australia
facility: Logan Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: St Albans
country: Australia
facility: Western Health
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: The University of Queensland
name: Ruth Hubbard
role: PRINCIPAL_INVESTIGATOR
References: