ANZCTR - Registration

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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 information initially 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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Surgery

Other surgery

Musculoskeletal

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]

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]

Primary Outcome 1: Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)

Timepoint [1]

Pre-admission, 6 weeks, 3 months & 6 months post-surgery

Secondary outcome [1]

5-level 5-dimension EuroQoL (EQ-5D-5L)

Timepoint [1]

Pre-admission, 6 weeks, 3 months & 6 months post-surgery

Secondary outcome [2]

Self-Efficacy for Managing Chronic Disease (SEMCD)- 6 item

Timepoint [2]

Pre-admission, 6 weeks, 3 months & 6 months post-surgery

Secondary outcome [3]

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]

6 weeks post-surgery

Secondary outcome [4]

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]

6 months post-surgery

Secondary outcome [5]

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]

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?

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Hollywood Private Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hollywood Private Hospital

Address [1]

Hollywood Private Hospital, Monash Avenue, Nedlands, WA, 6009

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hollywood Private Hospital Research Ethics Committee

Ethics committee address [1]

Hollywood Private Hospital Monash Avenue, Nedlands, WA, 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/08/2017

Approval date [1]

07/09/2017

Ethics approval number [1]

HPH505

Ethics committee name [2]

Edith Cowan Univeristy Human Research Ethics Committee

Ethics committee address [2]

Office of Research and Innovation, 270 Joondalup Drive, Joondalup, WA 6027

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

12/09/2017

Approval date [2]

15/09/2017

Ethics approval number [2]

19065

Summary

Brief summary

A private hospital in Western Australia introduced a pilot Enhanced Recovery Program (ERP) for THR in 2012 based on an orthopaedic recovery program established in United Kingdom (Wainwright & Middleton, 2010). The ERP for THR included a range of strategies to support the pre-admission, peri-operative, post-operative and post-discharge patient care. After an extensive evaluation of the pilot program the ERP was introduced as part of standard care in 2013 and has continued as standard care. The education components of the ERP include information book, hospital based pre-operative education session and post-operative phone follow-up. Patient feedback of the ERP was positive but for patients living in rural locations it was difficult to attend the pre-operative education session. The private hospital recognised a virtual platform as a solution to provide information for all patients undergoing a THR and also provide a patient clinician interface in the post-discharge period. The private hospital commissioned the development of a virtual program for THR and plan to implement a pilot study to compare the effects of the virtual program versus the standard program for patients undergoing primary THR replacement on patient outcomes.
The aim of this study is to compare a virtual program versus standard program as part of care for primary total hip replacement (THR) on patient outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Rosemary Saunders

Address

Edith Cowan University, Building 21, 270 Joondalup Drive, Joondalup, WA, 6027

Country

Australia

Phone

+61 8 6304 3513

Fax

[email protected]

Contact person for public queries

Name

Ms Rosemary Saunders

Address

Edith Cowan University, Building 21, 270 Joondalup Drive, Joondalup, WA, 6027

Country

Australia

Phone

+61 8 6304 3513

Fax

[email protected]

Contact person for scientific queries

Name

Ms Rosemary Saunders

Address

Edith Cowan University, Building 21, 270 Joondalup Drive, Joondalup, WA, 6027

Country

Australia

Phone

+61 8 6304 3513

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4294	Study protocol	Saunders 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):e137	http://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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference abstract	No		McDowall, J. The My Hip Journey – An eHealth Progr... [More Details]
Other files	No		Ashford, C. My Hip Journey: Implementing an eHealt... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically