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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Frailty, Chronic Kidney Diseases

Intervention / Treatment
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* Other: Comprehensive Geriatric Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive Geriatric Assessment<br>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. | Other: Comprehensive Geriatric Assessment<br>* 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.<br>* Other names: CGA;|
| No Intervention: Usual Care<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Mortality | To determine whether CGA reduces mortality during the 12 months follow-up. | 12 months | 
| Duration of hospital admissions | To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up. | 12 months | 
| Number of hospital admissions | To determine whether CGA reduces the number of hospital admissions during the 12 months follow-up. | 12 months | 
| 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 | 
| Cost-effectiveness | Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Goal Attainment Scaling, Frailty Index