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
QCIF DataverseDataset description
An investigator-initiated multi-centre, cluster randomised controlled trial that is investigating if Comprehensive Geriatric Assessment (CGA) will allow frail older patients with chronic kidney disease (CKD) to better attain their treatment goals, and if this will benefit their quality of life and care outcomes while being cost-effective. 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.Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
NCT04538157
Funding
Not available
Scientific enquiries
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).
Key Inclusion 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 informe .... Read more
Key Exclusion Criteria
Can healthy volunteers participate?
No
Population
Sample Size Not Available
Min. age 55 Years
Max. age N/A
Sex All
Condition category Goal Attainment Scaling , Frailty Index
Condition code Frailty , Chronic Kidney Diseases
Intervention
Intervention code Other interventions - Comprehensive Geriatric Assessment
Comprehensive Geriatric Assessment Experimental 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. Usual Care No intervention Usual Care Other interventions: Comprehensive Geriatric Assessment A CGA is a diagnostic and therapeutic intervention which initially identifies an older person's medical, functional, psychosocial problems and then .... Read more
Comparison
Control group Not available
Comparison not available.
Outcomes
Not Available
Will the study consider sharing individual participant data?
Yes
What individual participant data might be shared?
STUDY_PROTOCOL,SAP
When can requests for individual participant data be made (start and end dates)?
Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
Who can request access to individual participant data?
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Where can requests to access individual participant data be made, or data be obtained directly?
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