Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000867897
Ethics application status
Approved
Date submitted
14/05/2021
Date registered
6/07/2021
Date last updated
12/01/2023
Date data sharing statement initially provided
6/07/2021
Date results information initially provided
12/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
App-based rehabilitation after total hip or knee arthroplasty: a randomised controlled trial
Scientific title
The effectiveness of a mobile app-based telerehabilitation program among patients after total hip or knee arthroplasty: a randomised controlled trial
Secondary ID [1] 302819 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total hip arthroplasty 319781 0
total knee arthroplasty 322320 0
Condition category
Condition code
Musculoskeletal 317714 317714 0 0
Osteoarthritis
Surgery 319991 319991 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: mobile app-based telerehabilitation program
The participants in the experimental group will receive a six-week mobile app-based telerehabilitation program on top of usual care. This program is based on the exercise regime of usual care, literature evidence, and the theoretical framework of this study – Bandura’s self-efficacy theory and Illeris’ model of learning. It aims to enhance patients’ self-efficacy in rehabilitation after total hip arthroplasty (THA) or total knee arthroplasty (TKA), improve their clinical outcomes such as physical function, pain, depression, anxiety, and eventually improve their health-related quality of life (HRQoL).
The program consists of physical exercises as well as techniques for enhancing self-efficacy and reducing stress. The exercise regime used in the telerehabilitation program is the same one as usual care. It includes exercises aiming to improve range of motion, muscle strength, activities and balance, such as heel slides, hip abduction and adduction, straight leg raise, bridge, standing march, walking, and steps and curbs. The exercises will be demonstrated by videos or photos via the mobile app WeChat. The participants will be recommended to practice the exercises for one hour daily and at least five days per week. On top of that, strategies to enhance participants’ self-efficacy in rehabilitation will be provided. To enhance participants’ direct mastery experiences, exercise goals are established and rehabilitation instructions are broken down into small tasks to help participants to achieve these goals. The participants will be encouraged to record their achievements in rehabilitation and pain relief on an in-paper diary, which aims to build their confidence based on their accomplishments. Each Monday the researcher (QW) will send a message to remind the participants of taking exercises as well as recording the diary. Videos and messages where previous patients who have participated in rehabilitation share their experiences are provided in WeChat. An asynchronous discussion forum which involves participants, researchers, an arthroplasty surgeon, a nurse, and a physiotherapist will be held via WeChat. Participants in the experimental group will be included in the discussion forum from the day before hospital discharge to six weeks after discharge. The participants may post their experiences and questions about rehabilitation at any time. The questions will be responded to by the researcher (QW) within 24 hours. To help relieve stress and anxiety, techniques such as muscle relaxation exercises will be included in this program. A validation panel which consists of an arthroplasty surgeon, a nurse, a physiotherapist, and two patients will be invited to review the content and give feedback about appropriateness and feasibility.
The researcher (QW) will deliver the intervention via WeChat to participants who rehabilitate at home. QW has experience in patient education and research experience in randomised controlled trials (RCTs). She receives rehabilitation training from the arthroplasty surgeon and will develop and conduct the intervention under the guidance of this surgeon. The mobile app WeChat will be the delivery medium as it is the most popular networking platform in China and is free of charge. Prior to the intervention, the researcher (QW) will teach the participants in the experimental group to use the rehabilitation program on WeChat. A take-home booklet will be provided to demonstrate how to use the app step by step.
Strategies will be adopted to assess patient adherence to the intervention. The numbers of days in which the participants use the WeChat program and complete their rehabilitation tasks will be tracked through the written rehabilitation diaries. The frequency of participants’ posts in discussion forum on WeChat will be counted to understand the online engagement.
Intervention code [1] 319100 0
Rehabilitation
Comparator / control treatment
Usual care
Home-based rehabilitation exercises are explained to the patients by the ward nurses at hospital discharge. Take-home rehabilitation instruction pamphlets are also provided. The home-based rehabilitation exercises consist of 12 exercises for THA and TKA, which aim to improve range of motion, muscle strength, activities and balance, such as heel slides, hip abduction and adduction, straight leg raise, bridge, standing march, walking, and steps and curbs. Patients are required to practice rehabilitation exercises according to the instructions for six weeks. If patients have any questions during rehabilitation, they can telephone the ward nurses. Patients will be followed up when they complete the rehabilitation exercises (i.e. six weeks after discharge) and four weeks later (i.e. 10 weeks after discharge).
Control group
Active

Outcomes
Primary outcome [1] 325762 0
Change in self-efficacy using Self-Efficacy for Rehabilitation Outcome Scale
Timepoint [1] 325762 0
Baseline (the day before hospital discharge), completion of the intervention (six weeks after hospital discharge), and four weeks later (10 weeks after hospital discharge).
The completion of the intervention that is six weeks after hospital discharge is considered the primary time endpoint.
Primary outcome [2] 325763 0
Change in physical function using Hip Disability and Osteoarthritis Outcome Score Physical Function Short Form (HOOS-PS) or Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)
Timepoint [2] 325763 0
Baseline (the day before hospital discharge), completion of the intervention (six weeks after hospital discharge), and four weeks later (10 weeks after hospital discharge).
The completion of the intervention that is six weeks after hospital discharge is considered the primary time endpoint.
Secondary outcome [1] 389051 0
Change in hip or knee pain using the Numeric Rating Scale of Pain
Timepoint [1] 389051 0
Baseline (the day before hospital discharge), completion of the intervention (six weeks after hospital discharge), and four weeks later (10 weeks after hospital discharge).
Secondary outcome [2] 389052 0
Change in depression using Hospital Anxiety and Depression Scale
Timepoint [2] 389052 0
Baseline (the day before hospital discharge), completion of the intervention (six weeks after hospital discharge), and four weeks later (10 weeks after hospital discharge).
Secondary outcome [3] 389053 0
Change in anxiety using Hospital Anxiety and Depression Scale
Timepoint [3] 389053 0
Baseline (the day before hospital discharge), completion of the intervention (six weeks after hospital discharge), and four weeks later (10 weeks after hospital discharge).
Secondary outcome [4] 389054 0
Change in health-related quality of life using EQ-5D-5L
Timepoint [4] 389054 0
Baseline (the day before hospital discharge), completion of the intervention (six weeks after hospital discharge), and four weeks later (10 weeks after hospital discharge).

Eligibility
Key inclusion criteria
The inclusion criteria are: 1) adults greater than or equal to 18 years after unilateral primary THA and TKA; 2) possessing a mobile device (e.g. smartphone or tablet) with internet connection; 3) being able to access the mobile app (WeChat); 4) being able to undertake the program and relevant follow-up in three months after hospital discharge; 5) being able to communicate with the researcher in Chinese (Mandarin); 6) giving informed valid consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The participants will be excluded if they: 1) undergo revision and bilateral arthroplasty; 2) have concomitant health conditions that may interfere with the rehabilitation exercises, such as class II or above heart failure according to New York Heart Association; 3) receive other lower-limb surgery in the last six months, or will undertake another lower-limb surgery within three months; 4) have severe vision impairment or blindness according to the International Classification of Disease 11; 5) have major postoperative complications such as incision infection and venous thromboembolism.

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)
The allocation results will be concealed to all researchers of this study. Allocations will be enclosed in identical, sequentially numbered, opaque, sealed envelopes, which are impermeable to intense light.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is calculated using the formula developed by Sugimoto et al., which is based on the effect size ratio and correlation coefficient of the co-primary outcomes: self-efficacy and physical function in this study. Based on previous studies in arthroplasty, we expect the effect size of the intervention on self-efficacy to be 1.2 and that on the physical function to be 0.7. The effect size ratio is approximately 1.7 (1.2/0.7). The correlation coefficient between these two outcomes is estimated to be 0.3. We set the attrition or nonresponse rate at 20% based on the evidence from a previous study (Walters et al., 2017). The present study requires a sample size of 84 in all (42 in each group) to achieve a power of 0.8 at a 0.025 level of alpha error. When the change was made, 69 participants had been recruited.
Categorical variables such as gender will be presented in frequencies and percentages, and continuous variables such as age will be presented in means and standard deviations or medians with interquartile ranges. The outcome analysis will be performed using the intention-to-treat principle. Generalised estimating equations will be used to evaluate the effects. The adjusted mean differences with 95% confidence intervals, significance levels, and effect sizes (Cohen d) at 6 weeks and 10 weeks post-discharge will be reported. Given the co-primary outcomes, the level of statistical significance is set as a 2-sided P value less than 0.025. No imputation will be conducted if the proportion of missing data is less than 5% as the generalised estimating equations can naturally integrate the missing data; otherwise, multiple imputations may be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/05/2021
Date of last participant enrolment
Anticipated
14/09/2021
Actual
6/12/2021
Date of last data collection
Anticipated
23/11/2021
Actual
14/02/2022
Sample size
Target
84
Accrual to date
Final
86
Recruitment outside Australia
Country [1] 23110 0
China
State/province [1] 23110 0
Shanghai

Funding & Sponsors
Funding source category [1] 307243 0
University
Name [1] 307243 0
University of Newcastle
Country [1] 307243 0
Australia
Primary sponsor type
Individual
Name
Sharyn Hunter
Address
School of Nursing and Midwifery, the University of Newcastle,
University Drive, Callaghan NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 307855 0
Individual
Name [1] 307855 0
Regina Lai-Tong Lee
Address [1] 307855 0
School of Nursing and Midwifery, the University of Newcastle,
University Drive, Callaghan NSW 2308, Australia
Country [1] 307855 0
Australia
Secondary sponsor category [2] 307856 0
Individual
Name [2] 307856 0
Sally Wai-Chi Chan
Address [2] 307856 0
Tung Wah College
18/F, Ma Kam Chan Memorial Building,
31 Wylie Road, Homantin, Hong Kong
Country [2] 307856 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307338 0
the Human Research Ethics Committee, the University of Newcastle, Australia
Ethics committee address [1] 307338 0
Research Integrity Unit, Research & Innovation Services
NIER Precinct, Block C
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 307338 0
Australia
Date submitted for ethics approval [1] 307338 0
16/11/2020
Approval date [1] 307338 0
26/04/2021
Ethics approval number [1] 307338 0
H-2020-0414

Summary
Brief summary
This study aims to evaluate the effectiveness of mobile app-based telerehabilitation among patients after total hip or knee arthroplasty. Participants will be the patients after THA or TKA in a university teaching hospital in Shanghai, China. Participants will be recruited preoperatively and randomly assigned to either the experimental or the control group on the day before hospital discharge. Once discharged, the control group will receive the usual care of the hospital. The experimental group will receive a six-week mobile app-based telerehabilitation program on top of usual care. Outcomes (i.e. physical function, self-efficacy, pain, depression, anxiety, and health-related quality of life) will be assessed at baseline (the day before discharge), six and ten weeks after hospital discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106886 0
Dr Sharyn Hunter
Address 106886 0
School of Nursing and Midwifery, University of Newcastle
University Drive, Callaghan, NSW 2308
Country 106886 0
Australia
Phone 106886 0
+61 2 4921 5957
Fax 106886 0
Email 106886 0
Sharyn.Hunter@newcastle.edu.au
Contact person for public queries
Name 106887 0
Dr Sharyn Hunter
Address 106887 0
School of Nursing and Midwifery, University of Newcastle
University Drive, Callaghan, NSW 2308
Country 106887 0
Australia
Phone 106887 0
+61 2 4921 5957
Fax 106887 0
Email 106887 0
Sharyn.Hunter@newcastle.edu.au
Contact person for scientific queries
Name 106888 0
Dr Sharyn Hunter
Address 106888 0
School of Nursing and Midwifery, University of Newcastle
University Drive, Callaghan, NSW 2308
Country 106888 0
Australia
Phone 106888 0
+61 2 4921 5957
Fax 106888 0
Email 106888 0
Sharyn.Hunter@newcastle.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?

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
SourceTitleYear of PublicationDOI
EmbaseMobile rehabilitation support versus usual care in patients after total hip or knee arthroplasty: study protocol for a randomised controlled trial.2022https://dx.doi.org/10.1186/s13063-022-06269-x
N.B. These documents automatically identified may not have been verified by the study sponsor.