Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000565448
Ethics application status
Approved
Date submitted
8/01/2016
Date registered
2/05/2016
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Date results information initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does training family to help with physiotherapy improve falls related self efficacy, physical activity and quality of life for older people transitioning from hospital to the community?
Scientific title
Does training family to help with physiotherapy improve falls related self efficacy, physical activity and quality of life for older people transitioning from hospital to the community?
Secondary ID [1] 287822 0
Nil known
Universal Trial Number (UTN)
U1111-1176-2972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fear of falling 296703 0
falls 296706 0
inactivity 296707 0
deconditioning 296708 0
caregiver strain 296709 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296942 296942 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to standard physiotherapy provided by physiotherapists within Transition Care, the experimental group will receive therapy from a family member, who will receive training and supervision from a research physiotherapist. Therapy will be tailored specifically to the individual, with their mobility or other goals in mind. Elements of therapy may include transfer practice, walking or simple strengthening or balance exercises considered safe for the family member to assist with.The involvement of the family member is also considered part of the intervention.
Participants (caregivers providing therapy) will receive up to four 30-60 minute face-to-face appointments with the physiotherapist to learn to provide therapy and monitor progress and any concerns the patient or caregiver may have. The family members will also receive contact via telephone or text message as required and according to patient and caregiver preference - over a period of four weeks, to provide support, monitor progress and answer any questions that may arise. Adherence to exercise will be measured using a paper exercise diary.
Intervention code [1] 293212 0
Rehabilitation
Intervention code [2] 293213 0
Prevention
Comparator / control treatment
Standard physiotherapy provided by physiotherapists or allied health assistants within Transition Care, which may include mobility training, strengthening or balance programs provided individually or in groups. Transition Care funds only small amounts of physiotherapy, so patients may be seen for short times daily, every few days or weekly. Some who are likely to be discharged to residential aged care facilities may receive little intervention.
Control group
Active

Outcomes
Primary outcome [1] 296551 0
Fear of falling / falls related self efficacy, measured with the Short Falls Efficacy Scale - International
Timepoint [1] 296551 0
At baseline (week 0) and after intervention (week 5)
Primary outcome [2] 296552 0
Number of falls - recorded on a falls diary
Timepoint [2] 296552 0
From baseline (week 0) to after the intervention (week 5)
Secondary outcome [1] 318738 0
Physical activity measured with an accelerometer
Timepoint [1] 318738 0
Measured over three to seven days prior to or from the beginning of the intervention period, and for three to seven days in the last week, or immediately after intervention (weeks 4 to 5).
Secondary outcome [2] 318739 0
Caregiver strain will be measured using the Modified Caregiver Strain Index
Timepoint [2] 318739 0
At baseline (week 0) and after intervention (week 5)
Secondary outcome [3] 318740 0
Self care and mobility activities of daily living measured using the Modified Barthel Index. This measure is routinely completed for patients in this program and will be collected from patient medical files.
Timepoint [3] 318740 0
Admission to and discharge from the Transition Care Program
Secondary outcome [4] 318741 0
Discharge destination will be recorded as home environment, residential care or other (including acute or subacute rehabilitation admission, and death)
Timepoint [4] 318741 0
Discharge from Transition Care Program
Secondary outcome [5] 318742 0
Length of stay in Transition Care Program measured as the number of nights a participant stays in the program.
Timepoint [5] 318742 0
From the day of admission to Transition Care to the day of discharge from Transition Care.
Secondary outcome [6] 318743 0
A sample of participants from each group will be interviewed to explore their experience in the trial.
Timepoint [6] 318743 0
After the intervention is complete.
Secondary outcome [7] 319792 0
Health related quality of life, measured using the EQ-5D-3L (the three level version of the EuroQoL five dimensional health related quality of life questionnaire)
Timepoint [7] 319792 0
At baseline (week 0) and after intervention (week 5)
Secondary outcome [8] 319793 0
Capability related quality of life, measured using the ICECAP-O questionnaire (ICEpop CAPability measure for Older people)
Timepoint [8] 319793 0
At baseline (week 0) and after intervention (week 5)

Eligibility
Key inclusion criteria
Patients:
- Admitted to Transition Care Program
- Able to stand with one assistant
- Able to follow single stage instructions
- Availability of a willing, eligible family member or friend
- Basic English comprehension

Family members:
- Aged 18 years or older
- Available to assist with therapy at least three times weekly
- Physically fit assessed by self-report
- English comprehension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded if they do not have a family member or friend able to participate, or if they are unable to stand without more than one person to assist.

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)
Allocations will be concealed in sequentially numbered, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated using an online randomisation program
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
Safety/efficacy
Statistical methods / analysis
A sample size of n=34 (17 in each group) will be recruited, which will be sufficient to detect a large effect size in the primary outcome of falls-related self-efficacy, assuming an effect size of 1.0, at power of 0.8 and an alpha level of 0.05.

Means will be calculated for each group at each time point (baseline and post intervention). Changes in means will be compared between groups using an analysis of covariance (ANCOVA).

Qualitative data will be analysed using thematic analysis and a phenomenological framework.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2016
Actual
23/12/2016
Date of last participant enrolment
Anticipated
28/02/2018
Actual
22/05/2018
Date of last data collection
Anticipated
31/07/2018
Actual
30/07/2018
Sample size
Target
34
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4588 0
Bundoora Extended Care Centre - Bundoora
Recruitment hospital [2] 8499 0
Peter James Centre - Forest Hill
Recruitment postcode(s) [1] 12192 0
3046 - Glenroy
Recruitment postcode(s) [2] 12193 0
3060 - Fawkner
Recruitment postcode(s) [3] 16591 0
3129 - Mont Albert North
Recruitment postcode(s) [4] 16590 0
3131 - Forest Hill

Funding & Sponsors
Funding source category [1] 292347 0
Other
Name [1] 292347 0
Australian Association of Gerontology
Country [1] 292347 0
Australia
Primary sponsor type
Individual
Name
Professor Nora Shields
Address
La Trobe University
School of Allied Health
College of Science, Health & Engineering
Bundoora
Victoria 3086
Country
Australia
Secondary sponsor category [1] 291023 0
Individual
Name [1] 291023 0
Professor Nicholas Taylor
Address [1] 291023 0
La Trobe University
School of Allied Health
College of Science, Health & Engineering
Bundoora
Victoria 3086
Country [1] 291023 0
Australia
Secondary sponsor category [2] 291024 0
Individual
Name [2] 291024 0
Katherine Lawler
Address [2] 291024 0
Physiotherapy Department, Peter James Centre, Mahoneys Road, Forest Hill 3131
Country [2] 291024 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293811 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 293811 0
Northern Health
185 Cooper Street
Epping
Victoria 3076
Ethics committee country [1] 293811 0
Australia
Date submitted for ethics approval [1] 293811 0
28/05/2015
Approval date [1] 293811 0
22/10/2015
Ethics approval number [1] 293811 0
HREC/15/NH/13
Ethics committee name [2] 293812 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 293812 0
Ethics and Integrity / Research Office
La Trobe University
Bundoora
Victoria 3086
Ethics committee country [2] 293812 0
Australia
Date submitted for ethics approval [2] 293812 0
26/10/2015
Approval date [2] 293812 0
28/10/2015
Ethics approval number [2] 293812 0
Northern Health HREC approved project - HREC/15/NH/13
Ethics committee name [3] 298143 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 298143 0
Austin Hospital, 145 Studley Road, Heidelberg, Victoria 3084
Ethics committee country [3] 298143 0
Australia
Date submitted for ethics approval [3] 298143 0
22/11/2016
Approval date [3] 298143 0
06/12/2016
Ethics approval number [3] 298143 0
HREC/16/AUSTIN/502
Ethics committee name [4] 298144 0
Eastern Health Human Research Ethics Committee
Ethics committee address [4] 298144 0
5 Arnold Street, Box Hill, Victoria 3128
Ethics committee country [4] 298144 0
Australia
Date submitted for ethics approval [4] 298144 0
17/10/2016
Approval date [4] 298144 0
15/11/2016
Ethics approval number [4] 298144 0
PA03-2016

Summary
Brief summary
This randomised controlled trial will evaluate the effectiveness of training family to help with physiotherapy for older people. It will formalise ad hoc arrangements of involving family in physiotherapy, and identify whether this approach is safe and effective for frail older people who have been in hospital, have become weak, and need time and support to get back on their feet. We will measure improvements in physical activity levels, as well as confidence with walking, and quality of life.
Trial website
Trial related presentations / publications
Public notes
Participants in this trial are older people with multiple health conditions admitted to a transitional care program after recent hospitalisation.

Contacts
Principal investigator
Name 61282 0
Prof Nora Shields
Address 61282 0
La Trobe University
School of Allied Health
College of Science, Health & Engineering
Bundoora
Victoria 3086
Country 61282 0
Australia
Phone 61282 0
+61 3 9479 5852
Fax 61282 0
Email 61282 0
n.shields@latrobe.edu.au
Contact person for public queries
Name 61283 0
Ms Katherine Lawler
Address 61283 0
Peter James Centre, Physiotherapy Department, Mahoneys Road, Forest Hill, Victoria 3131
Country 61283 0
Australia
Phone 61283 0
+61362264881
Fax 61283 0
Email 61283 0
katherine.lawler@utas.edu.au
Contact person for scientific queries
Name 61284 0
Ms Katherine Lawler
Address 61284 0
Peter James Centre, Physiotherapy Department, Mahoneys Road, Forest Hill, Victoria 3131
Country 61284 0
Australia
Phone 61284 0
+61362264881
Fax 61284 0
Email 61284 0
katherine.lawler@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No


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 Lawler, K., Shields, N., & Taylor, N. F. (2019). T... [More Details]
Study results articleYes Lawler, K., Taylor, N. F., & Shields, N. (2019). F... [More Details]

Documents added automatically
No additional documents have been identified.