Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000691448
Ethics application status
Approved
Date submitted
10/03/2016
Date registered
26/05/2016
Date last updated
6/02/2020
Date data sharing statement initially provided
6/02/2020
Date results information initially provided
6/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility of increasing inpatient rehabilitation therapy duration by implementing an additional self-directed independent exercise program: My Therapy.
Scientific title
The feasibilityof increasing inpatient rehabilitation therapy duration by implementing an additional self-directed independent exercise program: My Therapy.
Secondary ID [1] 288576 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopedic 297708 0
Falls 297709 0
Degenerative conditions 298340 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297892 297892 0 0
Occupational therapy
Physical Medicine / Rehabilitation 297893 297893 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The My Therapy program includes Occupational Therapy and Physiotherapy directed self-directed management elements. These are prescribed on an individual basis, dependent on therapist discretion and may include any of the following:
-cognitive rehabilitation
- relaxation and mindfulness
-upper limb management
-lower body dressing
- surgical precautions
-bed transfers
- strength, balance and range of movement exercises for both the upper limb and lower limb

Eligible patients will begin the My Therapy program on Day 2 of their admission, when admitted Monday to Friday. Those patients admitted over a weekend or public holiday however, will commence their My Therapy on Day 3 or 4 of admission. Patients will then be described 1, 2, or 3, sessions to complete daily during their admission from time of consent to discharge.

The independent My Therapy sessions shall be undertaken outside of formal therapy areas, most likely in the patient's hospital room.

The exercises that a patient completes as part of their My Therapy program, shall be provided in writing in the 'My Therapy' booklet that is kept by the patient, with an additional copy kept by the therapist to file in the medical record. Exercises will be prescribed by the patient's treating Physiotherapist and Occupational Therapist.

Patients will be prescribed a therapy set of exercises to perform between one and three times per day during their admission, dependent upon their rehabilitation goals. The amount of time that it takes a patient to complete their exercises will be recorded in their diary.

Patients will not be supervised during their My Therapy additional exercises, as those patients prescribed independent exercises are assessed by their therapist(s) as being safe for the patient to complete independently.

Exercises that may be prescribed may include, but are not limited to:
1) Upper Limb Exercises - shoulder shrug, scapula setting, elbow bends, arm raising, arm pulls
2) Seated Lower Limb Exercises - ankle pumps, seated marching, knee straightening,
3) Lower Limb Exercises - walking, sit to stand, squats, heel raises, straight leg behind, straight leg to the side, high knees, knee bends.

Cognitive Rehabilitation help stimulate the brain and keep the mind active. Exercises are prescribed by your Occupational Therapist and include memory skills, executive functioning and thinking skills.

Mindfulness is a simple exercise, that when performed regularly, assists with muscle tension release and improves sleep. Your Occupational Therapist will guide you through the script contained in your My Therapy Booklet to encourage deep breathing and restfulness.

Lower body dressing focuses upon the education and self practice in use of assistive aides including pick up sticks, long shoe horns and sock aides, to enable patients to achieve independence with daily lower body Dressing tasks.

Upper limb management includes education and practice of tasks such as dressing and fine motor tasks such as button and zips that therapists prescribe to patients in order for them to reach their rehab goals. Education is provided verbally at the time of practice, but also via content in the My Therapy booklet, that all participants are directed to read upon commencement.

Surgical precautions and restrictions are listed and explained in the My Therapy booklet for all patients following Orthopeadic surgery, as stated on post operative orders. This may include bed transfers for patients following hip surgery.

Therapists can use their own discretion to prescribe any further additional exercise(s) that are clinically indicated to assist a patient to reach their goals.

Adherence to the My Therapy program shall be evaluated via an audit of the My Therapy booklets. The percentage of rehabilitation days in which patients participated in their exercises will be recorded upon discharge.

For the purpose of this study, there is no set number, frequency or duration of physiotherapist and/or occupational therapist sessions with each participant during the My Therapy Project. These are all prescribed on an individual and case by case basis.
Intervention code [1] 293966 0
Rehabilitation
Comparator / control treatment
Pre-intervention group (control): refers to the period from the 1st March 2015 until the 31st May 2015 and this is before the implementation of the My Therapy Program at Cabrini Rehabilitation.

Post-implementation group: refers to the period from the 1st March 2016 until the 31st May 2016 when patients are receiving the My Therapy Program in addition to their usual care rehabilitation provided by the multi-disipinary team.
Control group
Historical

Outcomes
Primary outcome [1] 297409 0
The duration, in minutes, of rehabilitation therapy provided by the My Therapy Program, as recorded in a patients individual My Therapy diary.
Timepoint [1] 297409 0
3 months post the My Therapy Commencement
Secondary outcome [1] 320977 0
The feasibility of implementation of the My Therapy Program to the targeted patient cohort with the current Allied Health equivalent full time (EFT) assessed by staff online questionnaires, generated by the My Therapy team using the tool survey monkey.
.
Timepoint [1] 320977 0
3 months post the My Therapy Commencement
Secondary outcome [2] 320979 0
The 10 Metre Walk Test (10MWT) distance, number of steps and time in seconds to complete as recorded by treating Physiotherapist in the patient history.
Timepoint [2] 320979 0
During the 3 month period of trial implementation, the 10MWT will be assessed upon a patients discharge from rehabilitation. This is completed within 48 hours of their scheduled discharge date.
Secondary outcome [3] 322373 0
The compliance of therapists in exercise prescription and maintainence of exercise diaries assessed by staff online questionnaires, generated by the My Therapy team using the tool survey monkey.
Timepoint [3] 322373 0
3 months post implementation of the My Therapy program.
Secondary outcome [4] 322374 0
The compliance of patients in completing their prescribed exercises and recording in exercise diary is assessed by daily monitoring by therapists.
Timepoint [4] 322374 0
Daily during participation of the My Therapy Program during inpatient admission.
Secondary outcome [5] 322375 0
Length of rehabilitation stay assessed using Patient Administration System (PAS) online records.
Timepoint [5] 322375 0
During the 3 month period of trial implementation, post discharge from rehabilitation.
Secondary outcome [6] 322376 0
The functional independence measure (FIM) assessed using patient records on admission and discharge.
Timepoint [6] 322376 0
During the 3 month period of trial implementation, post discharge from rehabilitation.

Eligibility
Key inclusion criteria
Patients admitted to Cabrini Rehabilitation (either Hopetoun Street or Glenhuntly Road) sites under the Orthopedic Stream or Reconditioning Stream.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients identified as having a cognitive impairement: Past medical history of dementia or current history of delirium.
Patients who do not speak English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
31/05/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
158
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5634 0
Cabrini Health Elsternwick Rehabilition Service - Elsternwick
Recruitment hospital [2] 5635 0
Cabrini Hopetoun Rehabilitation Hospital - Elsternwick
Recruitment postcode(s) [1] 13088 0
3185 - Elsternwick

Funding & Sponsors
Funding source category [1] 292924 0
Hospital
Name [1] 292924 0
Cabrini Foundation
Country [1] 292924 0
Australia
Primary sponsor type
Hospital
Name
Cabrini Health
Address
Cabrini Health (Institute)
154 Wattletree Road
Malvern Victoria 3144
Country
Australia
Secondary sponsor category [1] 291680 0
None
Name [1] 291680 0
Address [1] 291680 0
Country [1] 291680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294429 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 294429 0
154 Wattletree Road
Malvern Victoria 3144
Ethics committee country [1] 294429 0
Australia
Date submitted for ethics approval [1] 294429 0
12/02/2016
Approval date [1] 294429 0
17/02/2016
Ethics approval number [1] 294429 0
CHREC 06-18-01-16

Summary
Brief summary
My Therapy is a proposed self-management program that patients complete outside of formal rehabilitation sessions. The program aims to compel the patient and, if required, their care-giver(s) to complete an independent therapy program as established by the team. The My Therapy program includes Occupational Therapy and Physiotherapy directed self-management elements including cognitive rehabilitation, relaxation and mindfulness, upper limb management, lower body dressing, surgical precautions, bed transfers, strength, balance and range of movement exercises. The program may be completed within business hours, in the evenings or over the weekends and is a way of promoting a partnership between clinical staff and the patient, in the hope of increasing not only the duration of rehabilitation, but also empowering the individual to better manage their health.
The current research project shall examine the feasibility of implementation of the My Therapy program by examining the duration that patients spend completing therapy exercises when admitted as an inpatient to Cabrini Hopetoun or Cabrini Glenhuntly under the Orthopaedic or Reconditioning streams. The research project shall aim to address the following questions: a) Does the introduction of the My Therapy program increase the duration (in minutes) of rehabilitation therapy? b) Is it feasible to implement the My Therapy program to the targeted patient cohort with the current Allied Health equivalent full time (EFT)? c) How can adherence to the My Therapy Program be achieved and maintained? What are the barriers and facilitators to adherence? It is anticipated that the introduction of the My Therapy program to rehabilitation inpatients, shall result in greater duration of rehabilitation that the patient participates in, during their inpatient rehabilitation admission. This would be a significant finding as there is strong evidence that patients who participate in a greater duration of rehabilitation during their inpatient rehabilitation admission, do better when they leave the hospital with respect to their function, mobility and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63362 0
Dr Tash Brusco
Address 63362 0
Cabrini Rehabilitation Physiotherapy Services
494 Glenhuntly Road
Elsternwick, Victoria, 3185
Country 63362 0
Australia
Phone 63362 0
+61395085225
Fax 63362 0
+61395085222
Email 63362 0
ltilley@cabrini.com.au
Contact person for public queries
Name 63363 0
Tash Brusco
Address 63363 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre
School of Primary and Allied Health Care
Monash University
Level 3, Building G, Peninsula Campus, McMahons Road
Frankston, VIC 3199
Australia
Country 63363 0
Australia
Phone 63363 0
+61 408251124
Fax 63363 0
None
Email 63363 0
tash@alphacrucisgroup.com.au
Contact person for scientific queries
Name 63364 0
Tash Brusco
Address 63364 0
Rehabilitation, Ageing and Independent Living (RAIL) Research Centre
School of Primary and Allied Health Care
Monash University
Level 3, Building G, Peninsula Campus, McMahons Road
Frankston, VIC 3199
Australia
Country 63364 0
Australia
Phone 63364 0
+61 408251124
Fax 63364 0
None
Email 63364 0
tash@alphacrucisgroup.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not supported for this study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.