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

September 12, 2022 updated by: The University of Queensland

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Laura Robison
  • Phone Number: +61427911414
  • Email: goal@uq.edu.au

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
        • Principal Investigator:
          • Shaundeep Sen, Dr
      • Gosford, New South Wales, Australia, 2250
        • Recruiting
        • Renal Research Gosford
        • Contact:
        • Principal Investigator:
          • Simon Roger, Dr
      • Liverpool, New South Wales, Australia, 2170
    • Queensland
      • Brisbane, Queensland, Australia, 4102
      • Cairns, Queensland, Australia, 4870
      • Logan, Queensland, Australia, 4138
      • Southport, Queensland, Australia
      • Toowoomba, Queensland, Australia, 4350
      • Townsville, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Shilpa Jesudason
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
        • Principal Investigator:
          • Paul Yates, Dr
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Western Health
        • Contact:
        • Principal Investigator:
          • Leny Hidayati, Dr
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital
        • Contact:
        • Principal Investigator:
          • Doris Chan, Dr
      • Perth, Western Australia, Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
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.
Other: 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.
Other Names:
  • CGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal Attainment Scaling at 3 months
Time Frame: 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
Time Frame: 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
Time Frame: 3, 6 and 12 months
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
Time Frame: 3, 6 and 12 months
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
Time Frame: 12 months
To determine whether CGA reduces mortality during the 12 months follow-up.
12 months
Duration of hospital admissions
Time Frame: 12 months
To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up.
12 months
Number of hospital admissions
Time Frame: 12 months
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
Time Frame: 12 months
To determine whether CGA reduces admissions to residential aged care facilities at 12 months follow-up.
12 months
Cost-effectiveness
Time Frame: 12 months
Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process evaluation
Time Frame: 12 months
Qualitative analysis of structured interviews.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Collaborators

National Health and Medical Research Council, Australia

Investigators

  • Principal Investigator: Ruth Hubbard, The University of Queensland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKTN 20.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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