Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001379404
Ethics application status
Approved
Date submitted
29/09/2016
Date registered
5/10/2016
Date last updated
5/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A web-support intervention to promote recovery following Anterior Cruciate Ligament Reconstruction
Scientific title
A novel web resource information and text messaging intervention to promote recovery following Anterior Cruciate Ligament Reconstruction: a pilot randomized controlled trial
Secondary ID [1] 290241 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACL reconstruction 300437 0
Condition category
Condition code
Injuries and Accidents 300300 300300 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 300329 300329 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three months Internet-based intervention (web resource information and text messaging).
The Internet-based resource comprises of two elements – information and communication. Information about ACL reconstruction, expected milestones during the recovery process, strategies to overcome distress associated with the injury, and recommended physiotherapy exercises.
Communication using frequent text messages to the participants via SMS (to their personal mobile phones) or emails. Participants can choose their preferred method of communication (SMS or emails)

Participants will be able to access the web-support resource as often as they wish and were encouraged to access it at least:
*On a daily basis for the first week following the surgery
*Three times per week for weeks 2-4 following the surgery
*Once a week for weeks 4-12 following the surgery

The SMS messages and emails encouraged the participants to access the web-support resource and check their progress by answering a set of questions each time. Based on the participant’s response, specific recommendations were suggested.
The SMS followed the rehabilitation guidelines and recommendation of accessing the website and included:
*A daily reminder for the first week following the surgery
*A reminder 3 times a week for weeks 2-4
*A reminder once a week for weeks 4-12
The SMS messages and emails included a statement or a question regarding a specific aspect of recovery, with a link to the website. The set of questions were based on certain goals or outcomes that are expected to be achieved during the rehabilitation phases following the surgery.
Participants in the intervention group will be advised to continue with the standard care their health care provider institutes. The Internet-based intervention group was differ from the standard care control group only by the inclusion of the interactive web-support resource as part of their rehabilitation phases following the surgery.
Intervention code [1] 296022 0
Rehabilitation
Intervention code [2] 296049 0
Treatment: Other
Comparator / control treatment
Control group (active control)– will be receiving the usual physiotherapy care after ACL reconstruction surgery (standard care) that their health care provider institutes
Control group
Active

Outcomes
Primary outcome [1] 299775 0
Self efficacy assessed by Knee Self Efficacy Scale
Timepoint [1] 299775 0
Baseline and at three months follow up
Primary outcome [2] 299776 0
Function assessed by The Knee Injury and Osteoarthritis Outcome Score (KOOS) sub score
Timepoint [2] 299776 0
At baseline and three months follow up
Primary outcome [3] 299777 0
Pain related fear of movement assessed by The Tampa Scale for Kinesiophobia
Timepoint [3] 299777 0
At baseline and at three months follow up
Secondary outcome [1] 328088 0
Fear about physical activity and work related activities assessed by Fear-Avoidance Beliefs Questionnaire (FABQ). A composite secondary outcome
Timepoint [1] 328088 0
At baseline and three months follow up
Secondary outcome [2] 328089 0
Physical activity using The short form International Physical Activity Questionnaires (IPAQ)
Timepoint [2] 328089 0
Three months follow up
Secondary outcome [3] 328090 0
Feasibility - website access (number of times and duration)
Timepoint [3] 328090 0
During the three months intervention period
Secondary outcome [4] 328091 0
Phone interview. Questions that discuss factors related to patients’ perception about the practicalities of the website and how they found it (questions for the intervention group only).
Timepoint [4] 328091 0
At three months follow up
Secondary outcome [5] 328128 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscore
Timepoint [5] 328128 0
At baseline and three months follow up
Secondary outcome [6] 328129 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS) - symptoms subscore
Timepoint [6] 328129 0
At baseline and three months follow up
Secondary outcome [7] 328130 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS)- knee-related quality of life subscore
Timepoint [7] 328130 0
At baseline and three months follow up
Secondary outcome [8] 328131 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS)- knee-related sports and recreational activities subscore
Timepoint [8] 328131 0
Three months follow up
Secondary outcome [9] 328132 0
Phone interview. Questions that discuss patients perception of their readiness to return to physical and sports activities (questions for both groups).
Timepoint [9] 328132 0
Three months follow up

Eligibility
Key inclusion criteria
(1) aged 18-45 years
(2) able to speak English and give informed consent
(3) had Internet access on a daily basis via mobile phone or a computer.
(4) Only patients undergoing Anterior Cruciate Ligament Reconstraction
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
had ACL surgery that includes meniscal repair.

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)
A single sequence of random assignments will be used (simple randomisation).
Allocation will be concealed - central randomisation will be performed by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
This is a pilot study hence power calculation has not been conducted.
To determine trend for effectiveness the following statistical approach will be used:
For the qualitative data - Repeated measures ANCOVA to evaluate the differences between groups (baseline vs three months post) and between groups over time s while controlling for age and gender.
For qualitative phone interview - interviews will be audio-taped and transcribed verbatim. Collected qualitative data will be reviewed to determine if the intervention is acceptable and to ascertain if modifications were required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2014
Date of last participant enrolment
Anticipated
Actual
18/12/2015
Date of last data collection
Anticipated
Actual
12/03/2016
Sample size
Target
40
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6752 0
Williamstown Hospital - Williamstown
Recruitment hospital [2] 6753 0
Western Hospital - Footscray
Recruitment postcode(s) [1] 14396 0
3016 - Williamstown
Recruitment postcode(s) [2] 14397 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 294608 0
Other Collaborative groups
Name [1] 294608 0
Australian Institute for Musculoskeletal Sciences
Country [1] 294608 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Ballarat Rd, Footscray 3011
Melbourne
Country
Australia
Secondary sponsor category [1] 293472 0
Hospital
Name [1] 293472 0
Western Health
Address [1] 293472 0
Sunshine Hospital, Furlong Rd, St Albans VIC 3021
Country [1] 293472 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296051 0
Melbourne Health
Ethics committee address [1] 296051 0
Office for Research
6 East, Central Building
The Royal Melbourne Hospital
300 Grattan Street
PARKVILLE VIC 3050
Ethics committee country [1] 296051 0
Australia
Date submitted for ethics approval [1] 296051 0
16/10/2013
Approval date [1] 296051 0
23/11/2013
Ethics approval number [1] 296051 0
2013.136

Summary
Brief summary
This was a pilot randomised controlled trial that examined the feasibility of a three months ‘internet-based intervention’ as a possible tool to enhance recovery and to examine how the intervention be perceived and if potential benefits can be identified. The potential effect of the internet-based intervention on knee pain, function, self efficacy and fear of pain were also assessed. The study would provide preliminary results, which could then help to determine whether such intervention is appropriate for further testing on a larger scale
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 68314 0
A/Prof Pazit Levinger
Address 68314 0
College of Sport and Exercise Science
VICTORIA UNIVERSITY
PO Box 14428
MELBOURNE VIC 8001
Country 68314 0
Australia
Phone 68314 0
+61-3-99195525
Fax 68314 0
Email 68314 0
[email protected]
Contact person for public queries
Name 68315 0
A/Prof Pazit Levinger
Address 68315 0
College of Sport and Exercise Science
VICTORIA UNIVERSITY
PO Box 14428
MELBOURNE VIC 8001
Country 68315 0
Australia
Phone 68315 0
+61-3-99195525
Fax 68315 0
Email 68315 0
[email protected]
Contact person for scientific queries
Name 68316 0
A/Prof Pazit Levinger
Address 68316 0
College of Sport and Exercise Science
VICTORIA UNIVERSITY
PO Box 14428
MELBOURNE VIC 8001
Country 68316 0
Australia
Phone 68316 0
+61-3-99195525
Fax 68316 0
Email 68316 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
SourceTitleYear of PublicationDOI
EmbaseA novel web-support intervention to promote recovery following Anterior Cruciate Ligament reconstruction: A pilot randomised controlled trial.2017https://dx.doi.org/10.1016/j.ptsp.2017.06.001
N.B. These documents automatically identified may not have been verified by the study sponsor.