Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
- Conditions
- FrailtyChronic Kidney Diseases
- Interventions
- Other: Comprehensive Geriatric Assessment
- Registration Number
- NCT04538157
- Lead Sponsor
- The University of Queensland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comprehensive Geriatric Assessment Comprehensive Geriatric Assessment 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.
- Primary Outcome Measures
Name Time Method Goal Attainment Scaling at 3 months 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.
- Secondary Outcome Measures
Name Time Method Number of residential aged care facility admissions 12 months To determine whether CGA reduces admissions to residential aged care facilities at 12 months follow-up.
Cost-effectiveness 12 months Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms
Goal Attainment Scaling at 6 and 12 months 6 and 12 months To determine whether CGA improves attainments of patients' own goals of care at six and 12 months.
Frailty status 3, 6 and 12 months 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.
Quality of life using EQ-5D-5L 3, 6 and 12 months 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
Mortality 12 months To determine whether CGA reduces mortality during the 12 months follow-up.
Number of hospital admissions 12 months To determine whether CGA reduces the number of hospital admissions during the 12 months follow-up.
Duration of hospital admissions 12 months To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up.
Trial Locations
- Locations (15)
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Blacktown Hospital
🇦🇺Blacktown, New South Wales, Australia
Logan Hospital
🇦🇺Logan, Queensland, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Gold Coast Hospital
🇦🇺Southport, Queensland, Australia
Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Townsville Hospital
🇦🇺Townsville, Queensland, Australia
Renal Research Gosford
🇦🇺Gosford, New South Wales, Australia
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Western Health
🇦🇺St Albans, Victoria, Australia