The GOAL Trial: Comprehensive Geriatric Assessment for Frail Older People with Chronic Kidney Disease to Increase Attainment of Patient-Identified Goals: A Cluster Randomised Controlled Trial
Principal Investigators: Professor Ruth Hubbard
Clinical Project Manager: Laura Robison
Clinical Research Associate: Julie Varghese, Misa Matsuyama
Trial Number: AKTN 20.1
Population: Adults aged over 65 years or over 55 years if Aboriginal Torres Strait Islander, with CKD (Stages 3-5) and a Frailty Index score over 0.25
Intervention: Comprehensive Geriatric Assessment (CGA) versus standard care
Follow-up: 12 months
Primary outcome: Goal Attainment Scaling at 3 months
Status: Recruitment to commence 1st Q 2021
Target Recruitment: 500 participants across 16 sites in Australia
Frailty is highly prevalent among older people with chronic kidney disease (CKD) and is associated with multiple adverse outcomes, including increasing disability, nursing home placement and death.
Comprehensive Geriatric Assessment (CGA) to identify and manage medical, psychosocial and functional needs is recommended for all older people who are frail; however, links between geriatric medicine and nephrology are currently weak and evidence on the effectiveness of CGA for patients with CKD remains limited.
Building on prior research to identify patient-important outcomes and validate a frailty index in older people with CKD, this multi-site cluster randomised controlled trial will examine the effect of CGA as opposed to usual care on frail patients (frailty index >0.25) with Stages 3 to 5 CKD. All patients will be followed up at 3, 6 and 12 months.
The primary outcome will be Goal Attainment Scaling, based on achievement of patients’ expressed health outcome goals. Secondary outcomes will be quality of life (EQ-5D) and frailty index as well as days in hospital, transfer to a residential aged care facility and mortality. A cost-utility analysis and process evaluation will also be undertaken.
The study has already received funding from the National Health and Medical Council Frailty Targeted Call for Research.