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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04538157




Registration number
NCT04538157
Ethics application status
Date submitted
6/08/2020
Date registered
3/09/2020

Titles & IDs
Public title
Comprehensive Geriatric Assessment for Frail Older People With Chronic Kidney Disease - The GOAL Trial
Scientific 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
Secondary ID [1] 0 0
AKTN 20.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 0 0
Chronic Kidney Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Comprehensive Geriatric Assessment

Experimental: 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.

No intervention: Usual Care - 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 tailors coordinated management plans to address them.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Goal Attainment Scaling at 3 months
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Goal Attainment Scaling at 6 and 12 months
Timepoint [1] 0 0
6 and 12 months
Secondary outcome [2] 0 0
Quality of life using EQ-5D-5L
Timepoint [2] 0 0
3, 6 and 12 months
Secondary outcome [3] 0 0
Frailty status
Timepoint [3] 0 0
3, 6 and 12 months
Secondary outcome [4] 0 0
Mortality
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Duration of hospital admissions
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Number of hospital admissions
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Number of residential aged care facility admissions
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Cost-effectiveness
Timepoint [8] 0 0
12 months

Eligibility
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)
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Renal Research Gosford - Gosford
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [6] 0 0
Cairns Hospital - Cairns
Recruitment hospital [7] 0 0
Logan Hospital - Logan
Recruitment hospital [8] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [9] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [10] 0 0
Townsville Hospital - Townsville
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 0 0
Austin Health - Heidelberg
Recruitment hospital [13] 0 0
Western Health - St Albans
Recruitment hospital [14] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment postcode(s) [7] 0 0
4138 - Logan
Recruitment postcode(s) [8] 0 0
- Southport
Recruitment postcode(s) [9] 0 0
4350 - Toowoomba
Recruitment postcode(s) [10] 0 0
- Townsville
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3021 - St Albans
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment postcode(s) [15] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ruth Hubbard
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (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.
Available to whom?
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04538157