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Trial registered on ANZCTR


Registration number
ACTRN12620000607976
Ethics application status
Approved
Date submitted
22/04/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does provision of computerised cognitive training for an extended period of time in older hospitalised patients help in improving their frailty status?
Scientific title
Does extended computerised cognitive training improve frailty status of acutely hospitalised older patients?
Secondary ID [1] 301097 0
Nil Known
Universal Trial Number (UTN)
U1111-1250-7457
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Frailty 317170 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315323 315323 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive cognitive training, which will be administered by the use of study iPADs loaded with Flinders Assistant for Memory Enhancement (FAME) application. FAME is a tablet based platform used to provide assistive mobile tools and deliver brain training and physical activity interventions to older adults wishing to counteract mild memory loss. Daily training sessions will be provided by a trained research assistant during hospital admission, until participants are proficient to use this program. Thereafter, participants will be instructed to continue practicing 'brain training' for at least one hour per day for 12 weeks in their own homes. Participants will receive fortnightly telephone calls from the research assistant to ensure compliance with the intervention and to address any technical issues arising during the study period.
Intervention code [1] 317406 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive no cognitive training but will be offered usual care for frail patients which includes improvement in nutrition and physiotherapy. This may involve provision of dietary advice and or oral nutritional supplements (ONS) by a dietitian and balance and exercise training by a physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 323574 0
The primary outcome will be to determine whether cognitive training improves frailty status as determined by a change in frailty scores by the use of Edmonton frail scale (EFS) and the proportion of participants who demonstrate a reduction of frailty status as determined by the EFS.
Timepoint [1] 323574 0
at 12 weeks following commencement of intervention.
Secondary outcome [1] 382253 0
To determine whether the intervention reduces the incidence of falls as self-reported by the participant and assessed by the number of events person coming to rest inadvertently on the ground or floor or lower level against gravity.
Timepoint [1] 382253 0
at 12 weeks following commencement of intervention.
Secondary outcome [2] 382259 0
To determine whether the intervention reduces the number of unplanned hospital readmissions as determined through the hospital computer data base
Timepoint [2] 382259 0
at 12 weeks following the commencement of intervention.
Secondary outcome [3] 382260 0
health-related quality of life as determined by the European Quality of life (EQol) index and on visual analogue scale (VAS) by using the EQoL questionnaire.
Timepoint [3] 382260 0
at 12 weeks following commencement of intervention.

Eligibility
Key inclusion criteria
- Patients >= 65 years of age identified as frail or pre-frail patients using the Edmonton Frail Scale (EFS) and admitted under the General Medicine service at Flinders Medical Centre (FMC).
- At least one self-reported history of fall or self-reported history of balance impairment in last 2 years
- Score of greater than or equal to 24 on the Mini-Mental State Examination (MMSE).
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients requiring palliative care
- Completed cognitive program within the last year
- Colour-blindness or a visual acuity of less than 20/80
- Bedbound with severe walking or balance impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research assistant who will be recruiting patients will be blinded to allocation of participants. After consent is obtained the research assistant will call a central office to open an opaque envelope to allocate participants to control or intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be determined by a computer generated random number sequence produced by a statistician and stratified according to the baseline frailty status of the participants. The sequence will be placed in sealed, opaque, consecutively numbered envelopes and will be held securely at a central research office in FMC and will not be accessible by any member of the team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation was based on the findings of a previous study which suggested that participants who underwent cognitive training were able to maintain their 10-m gait speed (seconds) at the end of 10 weeks of intervention (mean change 0.10 SD (2.03)), while those in the control group declined (mean change –1.52 SD (1.68)). Assuming an alpha level of 0.05 and power of 0.8, a sample size of 44 (22 in each group) was calculated and assuming a withdrawal rate of 5% a total sample size of 50 (25 in each group) will be sufficient. We will use paired t tests or rank sum tests as appropriate to determine any changes in continuous variables from the baseline while Chi square statistics or Fisher's exact test will be used for comparison of categorical variables. Multivariate regression analysis will be used to determine changes in EFS scores between the two groups and the model will be adjusted for the following variables: nutritional status, exercise intervention received, vitamin D replacement and number of medications. All statistical analysis will be done by use of STATA software version 16.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16540 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30097 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305538 0
University
Name [1] 305538 0
Flinders University
Address [1] 305538 0
Flinders Drive
Bedford Park
South Australia 5042
Country [1] 305538 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 305949 0
University
Name [1] 305949 0
Flinders University
Address [1] 305949 0
Flinders Drive
Bedford Park
South Australia 5042
Country [1] 305949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305844 0
Southern Adelaide Clinical Human Research Ethics Committee (SA HREC)
Ethics committee address [1] 305844 0
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Ethics committee country [1] 305844 0
Australia
Date submitted for ethics approval [1] 305844 0
10/09/2019
Approval date [1] 305844 0
17/03/2020
Ethics approval number [1] 305844 0
213.19

Summary
Brief summary
Studies indicate that over half of the older patients admitted to hospitals are frail. Frail patients are at a high risk of falls, nursing home placement, unplanned readmissions and death.
Currently, there are limited treatment options to reverse frailty. Currently only limited studies have explored benefits of cognitive training in frail subjects. This study will determine whether provision of computerised cognitive training in older hospitalised patients improve their frailty status and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101794 0
Dr Yogesh Sharma
Address 101794 0
Division of Medicine and Critical Care
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 101794 0
Australia
Phone 101794 0
+61 882046694
Fax 101794 0
Email 101794 0
Yogesh.Sharma@sa.gov.au
Contact person for public queries
Name 101795 0
Dr Yogesh Sharma
Address 101795 0
Division of Medicine and Critical Care
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 101795 0
Australia
Phone 101795 0
+61 882046694
Fax 101795 0
Email 101795 0
Yogesh.Sharma@sa.gov.au
Contact person for scientific queries
Name 101796 0
Dr Yogesh Sharma
Address 101796 0
Division of Medicine and Critical Care
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 101796 0
Australia
Phone 101796 0
+61 882046694
Fax 101796 0
Email 101796 0
Yogesh.Sharma@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing has not been approved by ethics committee.
What supporting documents are/will be available?
No other documents available
Summary results
No Results