Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001089820
Ethics application status
Approved
Date submitted
22/02/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Occupational therapy home assessment via videolink for patients recovering after hip fracture
Scientific title
Feasibility and effectiveness of a technology-based remote occupational therapy home safety assessment for patients recovering after hip fracture
Secondary ID [1] 303460 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 318361 0
Condition category
Condition code
Injuries and Accidents 316374 316374 0 0
Fractures
Physical Medicine / Rehabilitation 316375 316375 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a therapy/ treatment intervention. Participants hospitalised for hip fracture and allocated to the intervention group will receive usual care by a multidisciplinary team during their hospital stay, as provided to the control group including a standardised initial occupational therapy assessment and completion of the Home Falls and Accidents Screening Tool (Home Fast) to gather information about the home environment and identify participants at risk of falling because of hazards at home. In addition, they will participate in a single technology-enabled 'real-time' remote assessment of the home environment which is anticipated to take approximately 1-hour. The home safety assessment will be conducted between 1 and 5 days prior to the expected discharge date or whenever the participant has recovered sufficiently to be able to participate, or within 24 hours post-discharge for patients discharged directly from acute settings with insufficient notice to arrange the telerehabilitation home safety assessment.

The occupational therapist will sit with the participant in the hospital linked via a video connection to a family member/carer at the participant’s home. The remote home safety assessment will be completed using a standardised home assessment report form taking into consideration the participant's functional capacity and potential environmental hazards.

The occupational therapist will provide advice and recommendations and plan targeted interventions to be completed in hospital in preparation for discharge home. The aim is to involve the participant/ family in collaborative decision-making to maximise functional capacity and confidence in returning home. The occupational therapist will work with the participant and their family to provide education about the safe use of adaptive equipment to assist in the home, simulation and practice of activities of daily living within the hospital setting, provision of information about available community services and external referrals where required.

Recommendations from the home assessment will be recorded on a standardised home assessment summary form and a copy will be given to the participant.
Intervention code [1] 318166 0
Rehabilitation
Intervention code [2] 321289 0
Lifestyle
Comparator / control treatment
The participants in the control group will receive usual care during their hospital stay by a multidisciplinary team including medical, nursing and allied health. Following referral to occupational therapy the treating occupational therapist will complete a standardised initial assessment including completion of the Home Falls and Accidents Screening Tool (Home Fast) to gather information about the home environment and identify participants at risk of falling because of hazards at home. Consistent with usual care for a patient not receiving a home-based assessment, the occupational therapist will see the participant during their hospital stay and will provide education about the safe use of adaptive equipment to assist in the home, simulation and practice of activities of daily living as appropriate within the hospital setting, provision of information about available community services and external referrals where required in preparation for discharge back into the community. The occupational therapist will document any recommendations and actions on a standardised home assessment summary form and provide the participant with a copy of the form.
Control group
Active

Outcomes
Primary outcome [1] 324558 0
Feasibility: Demand domain will be evaluated using data collected in a study database on the recruitment rate (comparing the number of people recruited to the number of potentially eligible participants) and documenting the reasons for non-participation. The number of people who are eligible but who are not able to participate because the treating occupational therapist makes a clinical decision that they will require an in-person home-based assessment prior to discharge will also be recorded in a study database.
Timepoint [1] 324558 0
30 days post-discharge from hospital
Primary outcome [2] 324559 0
Feasibility: Practicality domain will be evaluated using data collected in a study database on the length of the home safety assessment/ intervention, delays or cancellations for technical reasons and proportion of items on the standardised home assessment form unable to be assessed.
Timepoint [2] 324559 0
30 days post-discharge from hospital
Primary outcome [3] 326611 0
Feasibility: Acceptability domain will be evaluated by using participant (patient/ carer) responses to a questionnaire designed specifically for this study covering scheduling, costs, use of technology and outcomes of the intervention. The results will compare the satisfaction of the intervention group to the control group. Acceptability for participant occupational therapists will be evaluated by focus groups.
Timepoint [3] 326611 0
30 days post-discharge from hospital
Secondary outcome [1] 384973 0
Feasibility: Practicality domain will be evaluated by measuring the cost of delivery for the health service. This will include:
o Cost minimisation analysis to compare the direct health service costs for the usual care group compared to the intervention group for the original admission and for readmissions within the 30-day post discharge period
o Cost utility analysis shall combine the cost and quality of life utility index data to report the incremental cost effectiveness ratio for the cost per quality adjusted life year
o Cost effectiveness analysis shall combine the cost and functional status (Functional Independence Measure, FIM data) to report the incremental cost effectiveness ratio for change in the FIM.
Timepoint [1] 384973 0
On discharge and 30 days post-discharge from hospital
Secondary outcome [2] 384975 0
Efficacy: Number of falls reported by participants using a falls calendar. A fall is defined as an 'unexpected event in which the participants come to rest on the ground, floor or lower level.'

Falls will be further classified as injurious if the fall requires medical attention or any healthcare utilisation, and non-injurious if it does not.
Timepoint [2] 384975 0
30 days post-discharge from hospital
Secondary outcome [3] 384976 0
Efficacy: Number of readmissions to the health service using the health service data management system.
Timepoint [3] 384976 0
30 days post-discharge from hospital
Secondary outcome [4] 384977 0
Efficacy: Functional Independence Measure (FIM) measured by a credentialled assessor. The FIM consists of 18 items in two domains: motor (13 items) and cognitive (5 items). Each items is rated on a 7-point scale, where 1 reflects complete dependence and 7 reflects complete independence to complete daily tasks. Scores range from 18 (lowest function) to 126 (highest function). A change of 22 points on the FIM is regarded as clinically significant.
Timepoint [4] 384977 0
Baseline and 30 days post-discharge from hospital
Secondary outcome [5] 384979 0
Efficacy: Nottingham Extended Activities of Daily Scale (NEADL) which measures independence in activities of daily living
Timepoint [5] 384979 0
Baseline and 30 days post-discharge from hospital
Secondary outcome [6] 392117 0
Efficacy: Falls Efficacy Scale- International (FES-I) which measures anxiety and concern about falling during the performance of a range of activities of daily living
Timepoint [6] 392117 0
Baseline and 30 days post-discharge from hospital
Secondary outcome [7] 392118 0
Efficacy: EuroQOL EQ5D converted into a utility index to measure health-related quality of life
Timepoint [7] 392118 0
Baseline and 30 days post-discharge from hospital
Secondary outcome [8] 392119 0
Adherence to occupational therapy recommendations measured with a binary outcome (yes/no) according to whether each recommendation listed on the home assessment summary form completed by the occupational therapist had been implemented or not. Adherence will be determined by visual inspection of the home environment and/ or self-report by the participant.
Timepoint [8] 392119 0
30 days post-discharge from hospital
Secondary outcome [9] 398988 0
Efficacy: Number of overnight stays in hospital after discharge using the health service data management system.
Timepoint [9] 398988 0
30 days post-discharge from hospital

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion if they:
• Have been admitted to Eastern Health with a primary diagnosis of hip fracture
• Are aged 50 years and older
• Are expected to return to a private residence on discharge from hospital
• Have a family member who is willing to participate and has access to the technology
by which Eastern Health’s telehealth portal can be reached

Occupational therapists who work with participants enrolled in the study will be invited to participate in a focus group to discuss their perceptions of the telerehabilitation home safety intervention.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they:
• Have been admitted from a residential care facility
• Fracture their hip during an admission to hospital because this would not be a primary
diagnosis
• Have an extended non-weight bearing period
• Have advanced cancer
• Are refusing to participate in therapy
• Are displaying aggressive behaviour
• Have cognitive impairment (greater than 2 errors on the Short Portable Mental Status
Questionnaire) and no carer who is able to give informed consent to be involved in the
study
• Are identified by the occupational therapist as requiring an in-person home-based
assessment prior to discharge from hospital.

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)
Sealed opaque envelopes will be prepared by an independent researcher with no role in recruitment or assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned using a permuted block with a computer random number generator (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Effect size estimates of efficacy outcomes will be estimated using standardised mean differences for continuous outcomes and relative risk for dichotomous outcomes. Descriptive statistics and simple comparisons will be used to describe practicality. Interviews will be analysed thematically using an inductive approach. There is no set number for estimating sample size in a pilot randomised controlled trial but a sample of n=40 will be sufficient to gain estimates of effect with moderate confidence intervals, and will be sufficient to achieve saturation with qualitative analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18777 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 18778 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [3] 18779 0
Wantirna Health - Wantirna
Recruitment hospital [4] 18780 0
Maroondah Hospital - Ringwood East
Recruitment hospital [5] 18781 0
Peter James Centre - Forest Hill
Recruitment postcode(s) [1] 33223 0
3128 - Box Hill
Recruitment postcode(s) [2] 33224 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [3] 33225 0
3152 - Wantirna
Recruitment postcode(s) [4] 33226 0
3135 - Ringwood East
Recruitment postcode(s) [5] 33227 0
3131 - Forest Hill

Funding & Sponsors
Funding source category [1] 306285 0
University
Name [1] 306285 0
La Trobe University
Country [1] 306285 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road,
Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 306777 0
None
Name [1] 306777 0
Address [1] 306777 0
Country [1] 306777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306501 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 306501 0
Ethics committee country [1] 306501 0
Australia
Date submitted for ethics approval [1] 306501 0
28/02/2020
Approval date [1] 306501 0
23/07/2020
Ethics approval number [1] 306501 0
E20/004/60870
Ethics committee name [2] 307933 0
La Trobe University Human Research Ethics Committee
Ethics committee address [2] 307933 0
Ethics committee country [2] 307933 0
Australia
Date submitted for ethics approval [2] 307933 0
09/09/2020
Approval date [2] 307933 0
14/09/2020
Ethics approval number [2] 307933 0
E20/004/60870

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

Contacts
Principal investigator
Name 104086 0
Dr Kylee Lockwood
Address 104086 0
Department of Occupational Therapy, Social Work & Social Policy
La Trobe University
Plenty Road
Bundoora, Victoria, 3086
Country 104086 0
Australia
Phone 104086 0
+61 3 9479 5820
Fax 104086 0
Email 104086 0
[email protected]
Contact person for public queries
Name 104087 0
Kylee Lockwood
Address 104087 0
Department of Occupational Therapy, Social Work & Social Policy
La Trobe University
Plenty Road
Bundoora, Victoria, 3086
Country 104087 0
Australia
Phone 104087 0
+61 3 9479 5820
Fax 104087 0
Email 104087 0
[email protected]
Contact person for scientific queries
Name 104088 0
Kylee Lockwood
Address 104088 0
Department of Occupational Therapy, Social Work & Social Policy
La Trobe University
Plenty Road
Bundoora, Victoria, 3086
Country 104088 0
Australia
Phone 104088 0
+61 3 9479 5820
Fax 104088 0
Email 104088 0
[email protected]

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 underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via website of journal publication linking to supplementary file containing individual participant data.


What supporting documents are/will be available?




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.