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

Chronic Kidney Diseases Clinical 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04538157
• Other study ID #: AKTN 20.01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 highly promising intervention for improving patient-important health outcomes in frail older people with Chronic Kidney Disease (CKD).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Frailty
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Comprehensive Geriatric Assessment
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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Blacktown Hospital	Blacktown	New South Wales
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Cairns Hospital	Cairns	Queensland
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Renal Research Gosford	Gosford	New South Wales
Australia	Austin Health	Heidelberg	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Logan Hospital	Logan	Queensland
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Gold Coast Hospital	Southport	Queensland
Australia	Western Health	St Albans	Victoria
Australia	Toowoomba Hospital	Toowoomba	Queensland
Australia	Townsville Hospital	Townsville	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process evaluation	Qualitative analysis of structured interviews.	12 months
Primary	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	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.	6 and 12 months
Secondary	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	3, 6 and 12 months
Secondary	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.	3, 6 and 12 months
Secondary	Mortality	To determine whether CGA reduces mortality during the 12 months follow-up.	12 months
Secondary	Duration of hospital admissions	To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up.	12 months
Secondary	Number of hospital admissions	To determine whether CGA reduces the number of hospital admissions during the 12 months follow-up.	12 months
Secondary	Number of residential aged care facility admissions	To determine whether CGA reduces admissions to residential aged care facilities at 12 months follow-up.	12 months
Secondary	Cost-effectiveness	Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms	12 months