Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001326583
Ethics application status
Approved
Date submitted
10/11/2015
Date registered
3/12/2015
Date last updated
3/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing falls in older people after discharge from hospital as a result of a fall
Scientific title
An exercise and education-based program for the prevention of falls in older people after discharge from hospital following admission as a result of a fall
Secondary ID [1] 287983 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 296736 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296976 296976 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 297057 297057 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise component:
The intervention will consist of a baseline assessment (approximately 1 hour within 1-2 weeks of discharge from hospital) with a researcher to gather preliminary data for quality of life, falls risk and functional capacity., Following baseline assessment, the exercise physiologist will undertake data collection (in a session of approximately 1 hour duration within 2 weeks of the initial baseline assessment) for mobility, strength and balance, as per assessment tools outlined below. design a program dependent upon the stratification of frailty.
For those deemed non-frail an exercise program will be designed, demonstrated and modified based on the Otago Exercise Programme . This programme consists of graduated lower limb strengthening and balance exercises that can be individually prescribed and modified according to the abilities of the individual. According to the Otago Exercise Programme protocol, the exercise physiologist will visit at one, two, four and eight weeks to ensure reduction of risk and enable tailoring of the program to participant needs. Participants will be provided with instruction on how to perform the exercises safely with the use of stable supports such as a table or assistance of a family member/carer. Participants will also be provided with a list of safety precautions, guidelines and diagrams of the exercises for their reference. Participants will be asked to undertake a 20-30 minute exercise program, three to five times per week for the duration of the intervention. The exercise physiologist will provide the participant with a log book to record their exercise activity and any comments they may wish to make about the effects of exercise (e.g. exercise difficulty, muscle soreness, barriers to exercise). A final assessment will be conducted at six months, undertaking the same measures as at baseline.
For participants deemed frail, the intervention will consist of the provision of functional exercises that can be performed safely and independently (such as sit to stand) and a home safety check to ensure that mobility and transfers are deemed safe.
Medication review component:
A review of medications will be conducted by a pharmacist with Home Medicines Review accreditation. It is anticipated that this pharmacist will be linked with the hospital pharmacy outreach service and be engaged on a casual basis to conduct the reviews. The pharmacist will be in contact with the GP within 1-2 weeks of the participant being randomised to the intervention group. A list of current medications will be obtained from the GP and a review of medicines conducted in the person's home (approximately 1 hour). Recommendations will be followed up the GP through a letter. A Drug Burden Index will be calculated. Medications will be assessed at the final six month assessment as part of the FROP-Com assessment tool.
Education component:
Participants will be provided with education from the exercise physiologist at visits one, two, four and eight weeks drawing on a falls prevention booklet, which includes risk factors for falls, environmental modification to reduce falls risk and what to do after a fall. Approximately 15 minutes of each session is allocated to one to one discussion, according to the person's high falls risk factors initially, the person's interest area, gradually working through the entire booklet. The booklet is to be used as a reference for the person, with any questions generated to be asked at the next session.
Intervention code [1] 293228 0
Rehabilitation
Intervention code [2] 293296 0
Prevention
Comparator / control treatment
The control group will receive usual care from their health and community care providers. Usual care potentially consists of supportive community services such as personal care, home help, social groups, and/or district nursing services. They will undergo an interview at the conclusion of the six months to understand their knowledge and confidence regarding falls prevention.
Control group
Active

Outcomes
Primary outcome [1] 296577 0
Health-related quality of life as measured on AQoL-8D
Timepoint [1] 296577 0
Six months
Secondary outcome [1] 318792 0
Rate of falls as measured by self-report by participant on study calendar, followed up with a phone call by research staff each month
Timepoint [1] 318792 0
Six months
Secondary outcome [2] 318793 0
Falls risk as measured by a physiotherapist on the FROP-Com assessment tool (13 sections covering key risk factors)
Timepoint [2] 318793 0
Six months
Secondary outcome [3] 318794 0
Dynamic balance assessed by Timed Up and Go Test
Timepoint [3] 318794 0
Six months
Secondary outcome [4] 318795 0
Exposure to anticholinergic and sedative medication as measured on the Drug Burden Index
Timepoint [4] 318795 0
Six months
Secondary outcome [5] 319030 0
Static balance assessed by Four Test Balance Scale
Timepoint [5] 319030 0
Six months
Secondary outcome [6] 319031 0
Independence in functional activity as measured on the Katz Index of Independence in Activities of Daily Living Scale
Timepoint [6] 319031 0
Six months
Secondary outcome [7] 319032 0
Strength of lower limbs as measured with the Sit to Stand Test
Timepoint [7] 319032 0
Six months
Secondary outcome [8] 319033 0
Fear of falling as measured on the Falls Efficacy Scale - International
Timepoint [8] 319033 0
Six months

Eligibility
Key inclusion criteria
1. People aged 65 years and over;
2. Hospitalised for a fall;
3. Discharged home from an acute care hospital (or < 1 week in sub-acute care) within metropolitan Melbourne;
4. Deemed medically fit to participate; and
5. New or existing RDNS clientele.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Weight bearing restrictions on discharge;
2. Medically unstable;
3. Terminal stage of an illness;
4. Rehabilitative, Geriatric Evaluation and Management Unit, or transition care hospital stay; and/or
5. Referred to specific falls prevention services post discharge.

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)
Allocation was concealed from the person who determined if a participant was eligible for inclusion in the trial.
Central randomisation was conducted by an independent person by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a block generated random number schedule. The randomisation will occur stratified for frailty, with the aim of having equal numbers of frail and non-frail individuals in the intervention and control groups.
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
Quantitative data analyses:
Analyses will be conducted according to the pre-defined statistical analysis plan on an intention-to-treat basis. All statistical tests will be two-sided and p-values will be considered significant when their values are less than 0.05. All analyses will be undertaken in SPSS 21 (Statistical Package for Social Scientists: IBM).
The main outcome measure will be improvement in quality of life (primary outcome).
Secondary analyses will be conducted to compare the number of falls, proportion of fallers in the two groups, falls risk, balance, functional ability and falls-risk increasing medicines (secondary outcomes).
Due to funding constraints, this study will be classed as a pilot study, with no sample size calculation made.
Qualitative data analyses:
Interviews will be audio recorded, transcribed and imported into NVIVO10 to aid a thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/10/2015
Date of last participant enrolment
Anticipated
31/03/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292360 0
Charities/Societies/Foundations
Name [1] 292360 0
Ian Rollo Currie Estate Foundation
Country [1] 292360 0
Australia
Funding source category [2] 292361 0
Charities/Societies/Foundations
Name [2] 292361 0
Isobel Hill Brown Charitable Trust
Country [2] 292361 0
Australia
Funding source category [3] 292362 0
Charities/Societies/Foundations
Name [3] 292362 0
Ethel Herman Charitable Trust
Country [3] 292362 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Royal District Nursing Service Institute
Address
31 Alma Road,
St Kilda, Victoria, 3182
Country
Australia
Secondary sponsor category [1] 291120 0
None
Name [1] 291120 0
Address [1] 291120 0
Country [1] 291120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293832 0
Royal District Nursing Service HREC
Ethics committee address [1] 293832 0
Ethics committee country [1] 293832 0
Australia
Date submitted for ethics approval [1] 293832 0
11/08/2015
Approval date [1] 293832 0
08/09/2015
Ethics approval number [1] 293832 0
150008

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

Contacts
Principal investigator
Name 61470 0
Dr Dianne Goeman
Address 61470 0
Royal District Nursing Service Institute,
31 Alma Road,
St Kilda, Victoria,
3182
Country 61470 0
Australia
Phone 61470 0
61 3 9536 5318
Fax 61470 0
Email 61470 0
[email protected]
Contact person for public queries
Name 61471 0
Claudia Meyer
Address 61471 0
Royal District Nursing Service Institute,
31 Alma Road,
St Kilda, Victoria,
3182
Country 61471 0
Australia
Phone 61471 0
61 3 8530 8105
Fax 61471 0
Email 61471 0
[email protected]
Contact person for scientific queries
Name 61472 0
Frances Batchelor
Address 61472 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital, Victoria, 3050
Country 61472 0
Australia
Phone 61472 0
61 3 8378 2383
Fax 61472 0
Email 61472 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes As per upload below 369603-(Uploaded-07-12-2020-10-26-51)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.