Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538157
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2020-08-06
Brief Title:
Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
Sponsor:
The University of Queensland
Organization:
The University of Queensland
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None