Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000098730
Ethics application status
Approved
Date submitted
27/10/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of electronic exercise prescription software on compliance with a physiotherapy program
Scientific title
Evaluating the impact of electronic exercise prescription software on compliance with a physiotherapy program in individuals with shoulder, hip, knee or lower back complaints
Secondary ID [1] 305673 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Single joint pathology requiring physiotherapy 324144 0
Condition category
Condition code
Musculoskeletal 321617 321617 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 321618 321618 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is exploring the role electronic exercise prescription software can play in improving adherence to a home exercise program and improving patient outcomes at the conclusion of there Physiotherapy care.

Patients will receive a home exercise program either via a smartphone app (specifically Physitrack) or via a paper printout. Exercise program adherence will be self reported by patients in an exercise diary either via their app or included with the paper print out of their exercises. The content, duration and composition of the home exercise program will be a clinical decision made by the treating Physiotherapist.

This intervention will be delivered in 2 public hospital Physiotherapy outpatient departments. Participants will be enrolled at their initial Physiotherapy consultation and will continue for a minimum of 1 follow up appointment up to a maximum of 2 follow up appointments with their Physiotherapist. It is anticipated the approximate length of patient participation will be no longer then 2 months with typical follow up 2-3 weeks after initial(and subsequent) appointments. Home exercise program frequency will be determined by the treating Physiotherapist based on their clinical assessment.
Intervention code [1] 322066 0
Rehabilitation
Intervention code [2] 322280 0
Treatment: Devices
Intervention code [3] 322663 0
Treatment: Other
Comparator / control treatment
The intervention will be compared against paper based printed handouts of a home exercise program.

The content, duration and composition of the home exercise program will be a clinical decision made by the treating Physiotherapist.

This comparator will be delivered in 2 public hospital Physiotherapy outpatient departments. Participants will be enrolled at their initial Physiotherapy consultation and will continue for a minimum of 1 follow up appointment up to a maximum of 2 follow up appointments with their Physiotherapist. It is expected the length of participation will be no longer then 2 months. Typical time between consultations is expected to be 2-3 weeks.
Control group
Active

Outcomes
Primary outcome [1] 329380 0
Patient reported home exercise program compliance via an exercise diary. This exercise diary will be completed via the smart phone app or on the paper based home exercise program.

Adherence rates will be calculated by an independent assessor based on patient self reported exercise completion rates in their exercise diaries.
Timepoint [1] 329380 0
Upon discharge from Physiotherapy care or after 2 follow up Physiotherapy appointments.
Primary outcome [2] 329986 0
Self reported daily home exercise program compliance rate as recorded by a home exercise program diary
Timepoint [2] 329986 0
Completion of trial
Secondary outcome [1] 402394 0
Composite outcome of the following patient reported outcomes as measured via the PROMIS-29 profile V2.0:
Physical Function,
Anxiety,
Depression,
Fatigue,
Sleep disturbance,
Ability to participate in social roles and activities,
Pain interference,
Pain intensity,
Timepoint [1] 402394 0
Upon discharge from Physiotherapy care or after 2 follow up Physiotherapy appointments.
Secondary outcome [2] 402395 0
Therapist reported Home exercise program technique via a 10 point Likert scale
Timepoint [2] 402395 0
Upon discharge from Physiotherapy care or after 2 follow up Physiotherapy appointments.
Secondary outcome [3] 404526 0
Participant satisfaction and knowledge of their prescribed HEP via 5 question Likert scale. This will be assessed as a composite outcome
Timepoint [3] 404526 0
Upon discharge from Physiotherapy care or after 2 follow up Physiotherapy appointments.

Eligibility
Key inclusion criteria
- Patients referred for Physiotherapy management of a Shoulder, Hip, Knee or Lower back complaint with our without referring symptoms.
- Referred for a single joint complaint requiring a home exercise program of at least 2 weeks duration as part of their Physiotherapy treatment plan
- Requiring a minimum of two Physiotherapist appointments (initial and follow up).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No access to a smart device or computer with internet access
- Referral for multi joint complaint

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A hypothesised mean improvement in exercise adherence of 10% for the intervention group has been utilised for power calculation.

In order to identify statistically significant between groups differences a sample size of 46 patients per group is needed. The historical departmental fail to attend appointment rate of 15% will be utilised to factor into calculations for participant drop out increasing sample size to 53 patients per group. This is based on 80% powering, 95% confidence intervals and pooled standard deviation (16.6) on exercise adherence rates reported in previous literature sources.

Sample size calculations for cluster based randomisation trials are complex calculations to ensure adequate powering is achieved . Additional patients are recommended to overcome issues of intra class correlations.

For the purpose of initial clustering size determination a presumed intra cluster correlation(ICC) (which is typically presumed ICC for cluster randomised trials) of 0.03 will be used. A simple calculation to determine the number of clusters required is sample size x ICC. which results in 2 clusters per group consisting of 27 patients. It is however recommended increasing recruitment numbers and clusters if possible to overcome limitations of reduced powering from cluster design.

Increasing the number of minimum clusters by 2(4 clusters per group) results in a sample size per cluster of 13 patients per cluster with a total of 4 clusters at each site.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/11/2021
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
28/03/2022
Actual
Sample size
Target
106
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20955 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 20956 0
Belmont Hospital - Belmont
Recruitment postcode(s) [1] 35782 0
2305 - New Lambton
Recruitment postcode(s) [2] 35783 0
2280 - Belmont
Recruitment postcode(s) [3] 35784 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 35785 0
2280 - Belmont North

Funding & Sponsors
Funding source category [1] 310033 0
Hospital
Name [1] 310033 0
Hunter New England Local Health District
Country [1] 310033 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Physiotherapy Department John Hunter Hospital, Lookout Road New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 311087 0
None
Name [1] 311087 0
None
Address [1] 311087 0
None
Country [1] 311087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309735 0
The Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309735 0
Ethics committee country [1] 309735 0
Australia
Date submitted for ethics approval [1] 309735 0
02/06/2021
Approval date [1] 309735 0
09/08/2021
Ethics approval number [1] 309735 0
21/07/21/4.01

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

Contacts
Principal investigator
Name 115206 0
Dr Ryan Gallagher
Address 115206 0
Physiotherapy Department John Hunter Hospital
Lookout Road New Lambton Heights NSW 2305
Country 115206 0
Australia
Phone 115206 0
+61 249223048
Fax 115206 0
Email 115206 0
[email protected]
Contact person for public queries
Name 115207 0
Ryan Gallagher
Address 115207 0
Physiotherapy Department John Hunter Hospital
Lookout Road New Lambton Heights NSW 2305
Country 115207 0
Australia
Phone 115207 0
+61 249223048
Fax 115207 0
Email 115207 0
[email protected]
Contact person for scientific queries
Name 115208 0
Ryan Gallagher
Address 115208 0
Physiotherapy Department John Hunter Hospital
Lookout Road New Lambton Heights NSW 2305
Country 115208 0
Australia
Phone 115208 0
+61 249223048
Fax 115208 0
Email 115208 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



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.