Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000813280
Ethics application status
Approved
Date submitted
14/09/2009
Date registered
18/09/2009
Date last updated
6/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The development and evaluation of a computer-based patient education programme as an adjunct to physiotherapy rehabilitation for shoulder injuries: a pilot study
Scientific title
The effect of a computer-based patient education programme on rehabilitation adherence and shoulder function when used as an adjunct to physiotherapy in patients with shoulder injuries: a pilot study
Secondary ID [1] 280508 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adherence to physiotherapy rehabilitation using computer-based patient education (CBPE). 243826 0
Soft tissue injuries of the shoulder 243864 0
Condition category
Condition code
Physical Medicine / Rehabilitation 240000 240000 0 0
Physiotherapy
Musculoskeletal 240001 240001 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CBPE programme consists of shoulder anatomy, shoulder exercises, adherence enhancing strategies, advise on functional activities and quizzes. Participants will be directed by their physiotherapists to the relevant content for their disorder. The programme will be available to the participants for 4 weeks, during which time they can access it at any time. Participants will be expected to exercise daily. There will also be access to a chat room for social support which will require the participants to have a user name and login.
Intervention code [1] 241265 0
Rehabilitation
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240903 0
Adherence to home-based physiotherapy rehabilitation
Timepoint [1] 240903 0
Daily self-report for 4 weeks of the home-based programme
Primary outcome [2] 240904 0
Shoulder Function using the Disabilities of Arm, Shoulder and Hand questionnaire (DASH).
Timepoint [2] 240904 0
Baseline and end of study (4 weeks later)
Secondary outcome [1] 257595 0
Self-efficacy with the physiotherapy programme will be measured by task self-efficacy, coping self-efficacy and relapse self-efficacy self report questionnaires.
Timepoint [1] 257595 0
Task and coping self-efficacy will be measured at baseline and end of study (4 weeks later). Relapse self-efficacy will be measured at the end of study (4 weeks)
Secondary outcome [2] 257596 0
Knowledge will be measured by a questionnaire that assesses the participants knowledge of their injury, physiotherapy and the use of adherence enhancing strategies.
Timepoint [2] 257596 0
Baseline and end of study (4 weeks later).
Secondary outcome [3] 257597 0
Intentions will measured by a self-report questionnaire about the participants intentions to follow the physiotherapy.
Timepoint [3] 257597 0
Baseline
Secondary outcome [4] 257598 0
Social Support will measured by a self-report questionnaire about the support the participants are receiving from their friends and family with regard to their physiotherapy.
Timepoint [4] 257598 0
Baseline and end of study (4 weeks later)
Secondary outcome [5] 257599 0
Satisfaction with the CBPE programme will be measured by a self-report questionnaire.
Timepoint [5] 257599 0
End of study (4 weeks later)

Eligibility
Key inclusion criteria
Soft tissue injury of the shoulder
At least 25 years of age
Understand written and spoken English
Have access to internet facilities
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No history of shoulder surgery
Any health conditions that may adversely effect the participants abiltiy to undertake shoulder exercises.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2138 0
New Zealand
State/province [1] 2138 0

Funding & Sponsors
Funding source category [1] 243729 0
Charities/Societies/Foundations
Name [1] 243729 0
New Zealand Society of Physiotherapy Scholarship Award Trust Fund - submitted
Country [1] 243729 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
New Zealand Society of Physiotherapy Scholarship Award Trust Fund - submitted
Address
Level 5,
195-201 Willis St,
Wellington, 6011
New Zealand
Country
New Zealand
Secondary sponsor category [1] 237090 0
None
Name [1] 237090 0
Address [1] 237090 0
Country [1] 237090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243855 0
Health and Disability Ethics Committee, Northern Region Committee X
Ethics committee address [1] 243855 0
Ethics committee country [1] 243855 0
New Zealand
Date submitted for ethics approval [1] 243855 0
30/09/2009
Approval date [1] 243855 0
Ethics approval number [1] 243855 0

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

Contacts
Principal investigator
Name 30280 0
Address 30280 0
Country 30280 0
Phone 30280 0
Fax 30280 0
Email 30280 0
Contact person for public queries
Name 13527 0
Heather Clark
Address 13527 0
Department of Physiotherapy
North Shore Campus
Auckland University of Technology
Private Bag 92006
Auckland, 1142
Country 13527 0
New Zealand
Phone 13527 0
+64 9 921 9999 ext 7066
Fax 13527 0
+64 9 921 9620
Email 13527 0
[email protected]
Contact person for scientific queries
Name 4455 0
Heather Clark
Address 4455 0
Department of Physiotherapy
North Shore Campus
Auckland University of Technology
Private Bag 92006
Auckland, 1142
Country 4455 0
New Zealand
Phone 4455 0
+64 9 921 9999 ext 7066
Fax 4455 0
+64 9 921 9620
Email 4455 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
EmbaseAn application of the health action process approach to physiotherapy rehabilitation adherence.2014https://dx.doi.org/10.3109/09593985.2014.912710
N.B. These documents automatically identified may not have been verified by the study sponsor.