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Trial registered on ANZCTR


Registration number
ACTRN12617001433392
Ethics application status
Approved
Date submitted
20/09/2017
Date registered
10/10/2017
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Date results provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
My Hip Journey : A virtual program for patients undergoing a total hip replacement
Scientific title
Recovery outcomes after a total hip replacement for patients receiving a Virtual Program (VP) compared to a Standard Program (SP)
Secondary ID [1] 292895 0
Nil
Universal Trial Number (UTN)
U1111-1201-7319
Trial acronym
MHJ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Replacement 304742 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304065 304065 0 0
Physiotherapy
Surgery 304066 304066 0 0
Other surgery
Musculoskeletal 304067 304067 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The virtual program developed for total hip replacements has been designed to inform patients, support persons and relatives what to expect pre-operatively, while in hospital, post operatively and after discharge. Participants access the virtual program via a web link through the ‘My Hip Journey – Go Well Health’. It was designed to give access to information without the patient having to come to the hospital and at a time that suits them 24/7 and it is anticipated that participants use the program on a daily basis commencing two week prior to surgery through until 30 days post-surgery, however they have access to the program up to 12 months post-surgery. The program provides a suite of educational resources including fact sheets, videos, exercise videos and email reminders. The resources change as the patient progress through the program with focus on personal wellbeing and the importance of this in the pre-operative and post-operative periods some example include eating a well-balanced diet, continuing to exercise without increasing pain, medication management and bowel management. Each day the patient home screen when they login is their My Program window lists the videos, information and exercises that have been allocated for them to view/complete that day. Exercises are listed with number of sets and repetitions that the patient is required to do. Participants have access to the health professional team via the program email for 4 weeks post discharge, and can also invite their regular health care providers and/or support person to be part of the team. The health professional team can personalised the participants program and exercises by adding in number of sets and reps for each exercise.
Intervention fidelity will be assess using the website site analytics. After a participants watches a video or reads information they rate the information, the program marks it as read and provides information on how long the participant spent on that piece of information. Additionally, the exercise videos are marked completed by the participant once done. Automatically generated emails with the program are sent to the participants on a regular basis to inform participants of the information available on the platform. The professional care team have access to the platform and can view the website analytics for each participant.
Intervention code [1] 299131 0
Rehabilitation
Comparator / control treatment
The comparator, the standard program consists of participants receiving paper-based information, attending a one hour hospital based pre-operative education session and post- discharge phone follow-up. The education session that is presented by a Nurse, Occupational Therapist, Pharmacist and Physiotherapist, and participants are encouraged to bring their support person to session. The educational booklet in the standard program contain the same content as the intervention program but is delivered via paper. Examples of the content includes falls prevention, wound care, showering, healthy eating, returning to work, pain management and selecting a personal alarm.
Control group
Active

Outcomes
Primary outcome [1] 303392 0
Primary Outcome 1: Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [1] 303392 0
Pre-admission, 6 weeks, 3 months & 6 months post-surgery
Secondary outcome [1] 338819 0
5-level 5-dimension EuroQoL (EQ-5D-5L)
Timepoint [1] 338819 0
Pre-admission, 6 weeks, 3 months & 6 months post-surgery
Secondary outcome [2] 338820 0
Self-Efficacy for Managing Chronic Disease (SEMCD)- 6 item
Timepoint [2] 338820 0
Pre-admission, 6 weeks, 3 months & 6 months post-surgery
Secondary outcome [3] 338821 0
Patient Satisfaction Survey. Developed by the research team to see how satisfied patients were from the program they received. Patients in the virtual program will receive additional questions on the usability of the application.
Timepoint [3] 338821 0
6 weeks post-surgery
Secondary outcome [4] 338822 0
Web-based analytics for VP participants only. This will included utilization of web-based application such as modules entered and length of time spend on each module and satisfaction ratings within the application.
Timepoint [4] 338822 0
6 months post-surgery
Secondary outcome [5] 338823 0
Cost effectiveness analysis from a funder’s perspective conducted on an intention to treat basis.
If non-inferiority is shown, a cost effectiveness analysis comparing VP to SP will be conducted from a funder’s perspective on an intention to treat basis. Direct costs will include the service delivery costs associated with each programme (brochures, photocopying and web-based application fees) as well as the cost of follow-up care (i.e. email, telephone and face-to-face contact time with health professionals). Cost data will be collected from pre-admission through to 6 months post discharge using hospital medical records. Outcomes will include changes in HOOS and quality of life (measured using the EQ-5D-5L). Incremental cost-effectiveness ratios (i.e. comparing the difference in cost between VP and SP with the difference in the outcome) will be calculated for HOOS and Quality Adjusted Life Years, and sensitivity analysis conducted on the key parameters.
Timepoint [5] 338823 0
Commencing from 2 weeks prior to surgery to 6 months post-discharge

Eligibility
Key inclusion criteria
Inclusion criteria: A participant will be eligible to participate if they are undergoing a primary elective THR, can provided informed consent and have a minimum of a 3 week lead up time prior to surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: A participant will be exclude from the study they are having a revision of the THR is booked in for a bilateral THR or are having a THR following a fractured neck of femur or resurfacing hip, has had a previous THR, unable to converse in written or spoken English, has no access to a web based device or a risk assessment and prediction score less than 6

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 concealment will be conducted 'off site' only after consent has been obtained, in order of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization will be conducted to ensure equal number of participants are allocated each week using statistical software. This will be in weekly blocks of 10.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation were conducted based on the primary outcome the HOOS. A non-inferiority method was applied using existing data from Paulsen 2014 (minimal clinically important improvement) and Duivenvoorden 2013 (standard deviation). The calculations were conducted for 3 out of the 5 HOOS subscales and the QOL subscale required the largest sample size. Based on a power of 90% and 5% significant level 42 patients per group is needed. To allow for a dropout rate of approximately 15%, a sample size of 50 per group is required. Therefore, the estimated sample size for the study is 100 participants.
Data will be reported in accordance with the Consolidated Standards of reporting Trial (CONSORT) for non-inferiority trials. Data analysis will be completed using the principle intention to treat (ITT). Mean (SD), median (IQR) and percentages will be used to describe the characteristics of the study group.
An analysis of covariance will be used to address the primary outcome, comparing the two groups in terms of change in regards to hip function. If the treatment effect of the VP is within minimally clinical important improvement values of the control group non-inferiority will be implied. Treatment effects will be calculated on the pre-post intervention outcomes at 6 weeks. Further analysis will be performed on the post treatment to 3 month and 6 months post-surgery. The clinical treatment effect of each intervention group will be also analysed using independent t-test, tests of medians, non-parametric test and chi-squared tests on pre-to-post intervention changes across the range of outcome measures and patient satisfaction.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/10/2017
Actual
11/01/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
7/01/2019
Date of last data collection
Anticipated
31/05/2019
Actual
8/07/2019
Sample size
Target
100
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9033 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 17514 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 297527 0
Hospital
Name [1] 297527 0
Hollywood Private Hospital
Country [1] 297527 0
Australia
Primary sponsor type
University
Name
Edith Cowan Univeristy
Address
Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 296535 0
None
Name [1] 296535 0
Address [1] 296535 0
Country [1] 296535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298623 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 298623 0
Ethics committee country [1] 298623 0
Australia
Date submitted for ethics approval [1] 298623 0
24/08/2017
Approval date [1] 298623 0
07/09/2017
Ethics approval number [1] 298623 0
HPH505
Ethics committee name [2] 298628 0
Edith Cowan Univeristy Human Research Ethics Committee
Ethics committee address [2] 298628 0
Ethics committee country [2] 298628 0
Australia
Date submitted for ethics approval [2] 298628 0
12/09/2017
Approval date [2] 298628 0
15/09/2017
Ethics approval number [2] 298628 0
19065

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

Contacts
Principal investigator
Name 77686 0
Ms Rosemary Saunders
Address 77686 0
Edith Cowan University, Building 21, 270 Joondalup Drive, Joondalup, WA, 6027
Country 77686 0
Australia
Phone 77686 0
+61 8 6304 3513
Fax 77686 0
Email 77686 0
rosemary.saunders@ecu.edu.au
Contact person for public queries
Name 77687 0
Rosemary Saunders
Address 77687 0
Edith Cowan University, Building 21, 270 Joondalup Drive, Joondalup, WA, 6027
Country 77687 0
Australia
Phone 77687 0
+61 8 6304 3513
Fax 77687 0
Email 77687 0
rosemary.saunders@ecu.edu.au
Contact person for scientific queries
Name 77688 0
Rosemary Saunders
Address 77688 0
Edith Cowan University, Building 21, 270 Joondalup Drive, Joondalup, WA, 6027
Country 77688 0
Australia
Phone 77688 0
+61 8 6304 3513
Fax 77688 0
Email 77688 0
rosemary.saunders@ecu.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4294Study protocolSaunders R, Seaman K, Ashford C, Sullivan T, McDowall J, Whitehead L, Ewens B, Pedler K, Gullick K. An eHealth Program for Patients Undergoing a Total Hip Arthroplasty: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2018;7(6):e137http://www.researchprotocols.org/2018/6/e137/  373657-(Uploaded-26-08-2019-09-01-04)-Study-related document.pdf



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.