Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001202459
Ethics application status
Approved
Date submitted
25/08/2016
Date registered
31/08/2016
Date last updated
31/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the Mini-Mental State Examination, Cognitive Functional Independence Measure (FIM) and the Kettle Test in a Rehabilitation Setting and Ability to Predict Functional Outcomes Post Discharge.
Scientific title
Mini-Mental State Examination, Cognitive FIM Instrument and the Kettle Test Efficacy in Predicting Patient Functional Outcomes in a Rehabilitation Setting.
Secondary ID [1] 290022 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Decline 300042 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299934 299934 0 0
Occupational therapy
Mental Health 299999 299999 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Current measures of cognition utilised in rehabilitation are valuable diagnostically but often do not fully address the functional implications of cognitive deficits. One primary concern at discharge from hospital is predicting the ability of a patient to function independently or to estimate the degree of assistance required to do so. The focus of this study is on the use of the Kettle Test as a quick performance measure that is based on a complex everyday task and is designed to tap into basic and higher-level cognitive processes to predict cognitive function.

Patients participating in sub-acute rehabilitation in a tertiary hospital routinely participate in an Mini Mental State Examination (MMSE) and Cognitive Functional Independence Measure (FIM) assessment at admission and discharge. Following consent a participant will complete the Kettle Test with an Occupational Therapist in the hospital environment. This will be completed on admission and discharge. The Kettle Test will involve a 20-30 minute assessment at admission and discharge.

The motor subscale of the Functional Independence Measure (mFIM) will be used to assess functional status and improvement. Patients will be evaluated at admission and discharge by the rehabilitation team.

The mFIM will be used to examine functional outcomes because this score isolates functional activities from cognitive ratings, which are combined in the total FIM score. A Daily Living Self-Efficacy Scale will be completed on discharge to review a participant’s confidence about returning home by the Occupational Therapist.

Participants would receive a phone call within their first week post discharge to review their functional status (via the mFIM), management at home, caregiver support, community service use and representation rates. This telephone call will consist of a series of question and will be completed by an Occupational Therapist.

The participants would receive an additional phone call from an Occupational Therapist at one month post discharge to review functional status (via the mFIM), management at home, caregiver support, community service use, representation rates, medical status and deaths. We will also collect data concerning age, gender, length of rehabilitation stay (LOS) and diagnoses.
Intervention code [1] 295736 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299425 0
Correlation between MMSE, Cognitive FIM and Kettle Test scores
Timepoint [1] 299425 0
From participant assessments on hospital admission and hospital discharge.
Primary outcome [2] 299426 0
Motor FIM scores to measure functional status changes
Timepoint [2] 299426 0
Completed on admission, discharge, at 1 week and 1 month post discharge.
Secondary outcome [1] 327118 0
Representations at 1 week and 1 month post discharge from hospital and assessed during the follow up phone call completed by the Occupational Therapist and checked against hospital computer records.
Timepoint [1] 327118 0
1 week and 1 month post discharge from hospital
Secondary outcome [2] 327119 0
Death assessed during the follow up phone call completed by the Occupational Therapist.
Timepoint [2] 327119 0
1 week and 1 month post discharge from hospital
Secondary outcome [3] 327120 0
Length of Stay in the sub-acute rehabilitation ward
Timepoint [3] 327120 0
On discharge from hospital
Secondary outcome [4] 327121 0
Community service use identified on admission by the Occupational Therapist and compared at 1 week and 1 month post discharge. This includes all assistance for example physiotherapy, home and community care, community nursing and day hospitals, etc.
Timepoint [4] 327121 0
Measured on admission, 1 week and 1 month post discharge.

Eligibility
Key inclusion criteria
- Be admitted as an inpatient to the SCGH GEM
- Be alert and without severe receptive aphasia
- English Speaking
- Suspected mild cognitive impairment, identified from routine screening
- Benefit from rehabilitation
- Previously live independently in the community
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe receptive aphasia
- Non English speaking
-Cognitive impairment and unable to consent (MMSE < 20)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size adequacy was determined by the guidelines set by Bland and Altman1, where the standard error of the within-subject standard deviation (sw), is shown to depend on both number of subjects (n), and number of observations per subject (m). The 95% confidence interval (CI) for sw is determined to be sw +/ 1.96sw/v(2n(m-1). With 3 repetitions (m = 3), and requiring that the width of this interval is no more than +/- 0.1sw (so that we are confident that we know sw within 10%), the minimum sample size required to assess the agreement between Kettle, Mini Mental Status Examination and Cognitive FIM is 97.

Summary statistics, frequencies and descriptive plots will be used where appropriate. Intra-class correlations and Bland Altman plots will be used to assess the agreement between Mini Mental Status Examination, Cognitive FIM and Kettle cognitive test scores (standardisation techniques may be used). Linear mixed models will be used to assess the relationship between change in functional (FIM) and cognitive (Mini Mental Status Examination, Cognitive FIM and Kettle) scores.

1. Bland JM, Altman DG (1996) Statistics Notes: Measurement error. BMJ 313: 744. doi:10.1136/bmj.313.7059.744a. PubMed: 8819450.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/08/2015
Date of last participant enrolment
Anticipated
Actual
23/05/2016
Date of last data collection
Anticipated
25/07/2016
Actual
25/07/2016
Sample size
Target
97
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6547 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 14135 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 294390 0
Hospital
Name [1] 294390 0
Sir Charles Gairdner Hospital Research Advisory Committee
Country [1] 294390 0
Australia
Primary sponsor type
Individual
Name
Annette Barton
Address
Sir Charles Gairdner Hospital
Occupational Therapy
G Block, Lower Ground Floor
Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 293237 0
None
Name [1] 293237 0
Address [1] 293237 0
Country [1] 293237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295811 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 295811 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 295811 0
Australia
Date submitted for ethics approval [1] 295811 0
22/04/2015
Approval date [1] 295811 0
22/06/2015
Ethics approval number [1] 295811 0
2015-034

Summary
Brief summary
Current measures of cognition utilised in rehabilitation are valuable diagnostically but often do not fully address the functional implications of cognitive deficits. One primary concern at discharge from hospital is predicting the ability of a patient to function independently or to estimate the degree of assistance required to do so. The focus of this study is on the use of the Kettle Test as a quick performance measure that is based on a complex everyday task and is designed to tap into basic and higher-level cognitive processes to predict cognitive function.

The participant group would be recruited from patients participating in rehabilitation at the Sir Charles Gairdner Hospital (SCGH), Geriatric Evaluation and Management Unit (GEM). The study design is a Prospective Cohort Study. The Mini Mental Status Examination (MMSE) and Cognitive FIM Instrument are cognitive assessment tools currently used with inpatients on GEM. They are standardised tools involving a series of questions and paper based assessments.

The Kettle Test is a new cognitive assessment tool, which utilises a functional task. We wish to assess the Kettle Tests accuracy in detecting cognitive impairment, when compared to traditionally used assessment tools. Also we will assess all tools capacity to predict a patient’s functional capacity. Functional capacity will be measured via the motor component of the Functional Independence Measure (mFIM).

The study also includes questions from a Daily Living Self-Efficacy Scale to assess the level of individual’s belief in their functional abilities and confidence to return home.

Participants or their caregivers would receive a phone call within their first week post discharge to review their functional status (via the mFIM), management at home, caregiver support, community service use and representation rates.

The participants would receive an additional phone call at one month post discharge to review functional status (via the mFIM), management at home, caregiver support, community service use, representation rates, medical status and deaths. We will also collect data concerning age, gender, length of rehabilitation stay (LOS) and diagnoses.

It is anticipated that the Kettle Test will accurately detect cognitive functional deficits in adults with suspected cognitive impairments, and that the Kettle test will give clear and specific information about the functional abilities and impairments of the patient once discharged to the home environment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68570 0
Mrs Annette Barton
Address 68570 0
Sir Charles Gairdner Hospital
Occupational Therapy Department
G Block, Lower Ground Floor
Nedlands, Perth WA 6009
Country 68570 0
Australia
Phone 68570 0
+61 8 6457 2855
Fax 68570 0
Email 68570 0
[email protected]
Contact person for public queries
Name 68571 0
Kristie Harper
Address 68571 0
Sir Charles Gairdner Hospital
Occupational Therapy Department
G Block, Lower Ground Floor
Nedlands, Perth WA 6009
Country 68571 0
Australia
Phone 68571 0
+61 8 6457 2855
Fax 68571 0
Email 68571 0
[email protected]
Contact person for scientific queries
Name 68572 0
Kristie Harper
Address 68572 0
Sir Charles Gairdner Hospital
Occupational Therapy Department
G Block, Lower Ground Floor
Nedlands, Perth WA 6009
Country 68572 0
Australia
Phone 68572 0
+61 8 6457 2855
Fax 68572 0
Email 68572 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.