Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001253594p
Ethics application status
Submitted, not yet approved
Date submitted
10/11/2015
Date registered
16/11/2015
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a web-based preoperative coaching program on anxiety, pain and functional milestone attainment after knee replacement.
Scientific title
In knee replacement patients, does preoperative coaching, compared with standard care, influence anxiety, pain and functional milestone attainment?
Secondary ID [1] 287859 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 296739 0
Knee replacement 296751 0
Pain 296752 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296977 296977 0 0
Physiotherapy
Surgery 296982 296982 0 0
Other surgery
Musculoskeletal 296997 296997 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to standard care, the Study group will receive Pre-operative web-based "Your Coach for Knee Replacement" training modules providing cognitive and physical strategies to help patients cope with emotional and physical stressors experienced when having a knee replacement. Participants will be given access to 8 x 15 minute modules at their leisure within the 4-8 weeks before surgery. Topics include surgery expectations, preparing for surgery, physiotherapy regimes, walking with your new joint, keeping comfortable, self care, and preparing for home for home. Training modules will include educational text, tips, and strategies, interactive quizzes and how-to videos. Module completion and training module access time will be logged, with expectation a minimum of 75% of the modules to be completed for inclusion to the study analysis..
Intervention code [1] 293234 0
Rehabilitation
Intervention code [2] 293239 0
Prevention
Comparator / control treatment
Standard care at the hospital study is provision of a guidebook and information passed from staff during medical and nursing pre-admission contacts.
Control group
Active

Outcomes
Primary outcome [1] 296579 0
Anxiety (State Anxiety Inventory Index)
Timepoint [1] 296579 0
Baseline Pre-program, Pre-surgery (Within 1-5 days), Post surgery (Beginning of second week)
Primary outcome [2] 296580 0
Pain intensity (Numerical Rating Scale 0-10)
Timepoint [2] 296580 0
Baseline Pre-program, Pre-surgery (Within 1-5 days), Post surgery (Beginning of second week, 3 month, 1 year)
Primary outcome [3] 296581 0
Milestone: Discharge home ( measured by time in number of post-operative days from operation to hospital discharge)
Timepoint [3] 296581 0
Hospital discharge date
Secondary outcome [1] 318803 0
Satisfaction (Numerical Rating Scale 0-10)
Timepoint [1] 318803 0
Pre-surgery (Within 1-5 days), Post surgery (3 month, 1 year)
Secondary outcome [2] 318804 0
Knee function/ limitations (Oxford Knee Score)
Timepoint [2] 318804 0
Pre-surgery (Within 1-5 days), Post surgery (3 month, 1 year)
Secondary outcome [3] 318834 0
Functional milestone to First stand

Timepoint [3] 318834 0
Number of post-operative days from surgery to milestone
Secondary outcome [4] 318835 0
Functional milestone to first walks >5m without therapist physical contact
Timepoint [4] 318835 0
Number of post-operative days from surgery to milestone
Secondary outcome [5] 318836 0
Functional milestone to achieve 90 degrees knee bend (without acute pain device in situ)
Timepoint [5] 318836 0
Number of post-operative days from surgery to milestone

Eligibility
Key inclusion criteria
1. The individual has signed a Patient Informed Consent specific to this study, and approved by the Institutional Ethics Review Board.
2. The individual is between 18 and 90 years of age.
3. The individual clinically qualifies for total or unicondulyar knee replacement surgery
4. The individual possesses basic computer literacy skills and have internet access
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous knee joint replacement surgery.
2. Fractured femur, tibia or other complex surgical presentation
3. The individual is a prisoner, physically or mentally compromised (i.e. psychiatric disorder, dementia, alcohol or substance abuse), or unable to comply with scheduled evaluations and/or rehabilitation.
4. Patients with comorbidities causing severe mobility impairment (e.g. limb amputation, multiple sclerosis, muscular dystrophy, Parkinson’s disease, morbidly obese, hemiplegic, severe back pain).
5. Worker’s compensation claimants

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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)
Computer generated
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
4/01/2017
Actual
Date of last participant enrolment
Anticipated
30/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292364 0
Self funded/Unfunded
Name [1] 292364 0
Daniel Fick (Principle Investigator)
Country [1] 292364 0
Australia
Primary sponsor type
Individual
Name
Daniel Fick
Address
The Joint Studio, 1/ 85 Monash Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 291055 0
None
Name [1] 291055 0
None
Address [1] 291055 0
None
Country [1] 291055 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293834 0
Hollywood Private Hospital HREC
Ethics committee address [1] 293834 0
Monash Ave, Nedlands, WA 6009
Ethics committee country [1] 293834 0
Australia
Date submitted for ethics approval [1] 293834 0
11/11/2015
Approval date [1] 293834 0
Ethics approval number [1] 293834 0

Summary
Brief summary
This prospective, single-centre, randomised, clinical study assesses the impact of a web-based coaching program for knee replacement patients on anxiety, pain, and recovery of physical function. All patients will receive an educative guidebook issued by Hollywood Private Hospital and detailing their surgical and recovery course (Standard care). Those randomised to recieve Your Coach (YC) for Knee Surgery training will be given access to the web portal and be asked to complete care modules combining cognitive and physical strategies to help patients cope with emotional and physical stressors experienced when having a total joint replacement.

The primary objectives are to assess whether web-based program is effective in reducing anxiety and pain, and subsequently enables earlier attainment of physical milestones such as first stand, independence walking with an aid, and hospital discharge. The secondary objectives are to assess potential carry-over to improve joint function, quality of life and reported level of satisfaction with their care and surgical outcome in the longer term.

The study will enrol 44 participants over a 12 month period. The study time points will be pre-operatively at baseline and just prior to surgery, 1-2 weeks, 3-months and 1-year following surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61474 0
Mr Dan Fick
Address 61474 0
c/ The Joint Studio
1/85 Monash Ave, Nedlands, WA 6009
Country 61474 0
Australia
Phone 61474 0
+61 864609781
Fax 61474 0
Email 61474 0
[email protected]
Contact person for public queries
Name 61475 0
Samantha Haebich
Address 61475 0
c/ The Joint Studio
1/85 Monash Ave, Nedlands, WA 6009
Country 61475 0
Australia
Phone 61475 0
+61 864609781
Fax 61475 0
Email 61475 0
[email protected]
Contact person for scientific queries
Name 61476 0
Samantha Haebich
Address 61476 0
c/ The Joint Studio
1/85 Monash Ave, Nedlands WA 6009
Country 61476 0
Australia
Phone 61476 0
+61 864609781
Fax 61476 0
Email 61476 0
[email protected]

No information has been provided regarding IPD availability


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
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