Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001139763
Ethics application status
Approved
Date submitted
9/10/2013
Date registered
11/10/2013
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an autonomy-support intervention with physiotherapists
Scientific title
Evaluation of an autonomy-support intervention with physiotherapists: Effects on interpersonal style, relationship quality, and client adherence.
Secondary ID [1] 283381 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interpersonal relationships between physiotherapists and their clients 290279 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290666 290666 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 3-hour autonomy support intervention will be developed according to self-determination theory (Deci & Ryan 1985), recent meta-analytical evidence (Su & Reeve, 2011) and applications in pedagogical settings (e.g., Aelterman et al., 2013). The intervention will consist of three parts: (i) relevant theory, (ii) specific motivational strategies, and (iii) skills application. The relevant theory component will provide participants an overview of the key tenets of self-determination theory and the link between theory and practice. The specific motivational strategies applied in the second section will provide participants concrete guidelines applicable to common situations experienced in the physiotherapy environment. The final component, skills application, will provide participants with the opportunity to practice various motivating strategies. Pen-and-paper activities and role-playing exercises will enable participants to gain experience in developing action plans for their own practice. The session will be delivered as a single face-to-face group workshop, facilitated by a registered psychologist.

Aelterman, N., Vansteenkiste, M., Van Keer, H., De Meyer, J., Van Den Berghe, L., & Haerens, L. (2013). Development and evaluation of a training on need-supportive teaching in physical education: Qualitative and quantitative findings. Teaching and Teacher Education, 29, 64-75. doi: 10.1016/j.tate.2012.09.001

Deci, E. L., & Ryan, R. M. (1985). Intrinsic motivation and self-determination in human behavior. New York: Plenum.

Su, Y.L., & Reeve, J. (2011). A Meta-analysis of the Effectiveness of Intervention Programs Designed to Support Autonomy. Educational Psychology Review, 23, 159-188. doi: 10.1007/s10648-010-9142-7
Intervention code [1] 288104 0
Behaviour
Comparator / control treatment
An active control group will receive a session on up-to-date evidence on different treatment modalities for physiotherapists. The session will be designed such that it mirrors the experimental condition in time (3 hours), mode (face-to-face, single group session), and structure (theory/evidence, strategies, skills application).
Control group
Active

Outcomes
Primary outcome [1] 290685 0
Indicators of interpersonal relationship quality and functioning including: autonomy support (healthcare climate questionnaire), controlling behaviours (adaptation of the controlling coach behaviours scale), motivation (treatment self-regulation questionnaire), tripartite efficacy (self-efficacy, other-efficacy, relation-inferred self-efficacy), and relationship quality (relationship assessment scale).
Timepoint [1] 290685 0
Baseline (prior to randomisation) and 4 weeks after the delivery of the interventions.
Secondary outcome [1] 305037 0
Client-reported adherence (sport injury adherence scale)
Timepoint [1] 305037 0
Baseline (prior to randomisation) and 4 weeks after the delivery of the interventions.

Eligibility
Key inclusion criteria
Inclusion criteria for physiotherapists: participant (i) is an Australian-registered physiotherapist; (ii) has been employed as a physiotherapist for at least 12 months; (iii) is clinically active (engages in at least 5 hours of practice weekly); (iv) works with clients with chronic conditions (e.g., arthritis) or who require extended rehabilitation (e.g., athletes); and (v) is able to attend either of the two intervention sessions.

Inclusion criteria for clients: Client is (i) cognitively able to accurately complete the survey package, (ii) is willing and able to complete and return the survey packages to the researchers within the allotted time periods, and (iii) has a chronic condition or requires prolonged rehabilitation (>6 weeks).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for physiotherapists: participant (i) is not clinically active; (ii) has less than 12 months employment as a physiotherapist; (iii) has previous experience with related professional development activities such as motivational interviewing; and/or (iv) is unavailable for either of the two intervention sessions.

Exclusion criteria for physiotherapy clients: The client (i) suffers a cognitive ailment that would yield inaccurate completion of the survey packages, (ii) is not able nor willing to complete the survey package for any reason, and (iii) does not have a chronic condition or require prolonged rehabilitation (>6 weeks).

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)
Physiotherapists who meet the inclusion/exclusion criteria and register their interest to participate in the study will be directed to a website where they will complete a multi-section survey package.

Once baseline data is obtained, a computer generated program will be used to randomly assign half of the physiotherapists to either intervention or active control conditions. The allocation will be concealed as it will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation and allocation to intervention and active control groups will be conducted after baseline measures are completed by physiotherapists, and will occur at the cluster level (i.e., physiotherapist).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample sizes were calculated based on the effect sizes calculated from Lonsdale et al.’s (2012) study protocol for a similar intervention. A priori power analyses suggest an approximate sample size of 78 clients per condition to detect a between-group effect (alpha level of 0.05, power level of 0.80, effect size of 0.40). Application of the correction factor for the clustered nature of the data (i.e., approx 3 clients per physio, ICC of approx .10) means 187 clients will be required.

Statistical methods:
Multilevel modeling will be used to account for clustering of participants. Specifically, a two-level (client within physio) model will be examined. Effects of group allocation on the outcomes will be examined using a multilevel regression model. Two-tailed tests with an alpha level of .05 will be used to determine the significance of all results.

Lonsdale, C., Hall, A. M., Williams, G. C., McDonough, S. M., Ntoumanis, N., Murray, A., & Hurley, D. A. (2012). Communication style and exercise compliance in physiotherapy (CONNECT). A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: Study rationale, design, and methods. BMJ Musculoskeletal Disorders, 13, 104. doi: 10.1186/1471-2474-13-104

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
13/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288106 0
University
Name [1] 288106 0
Curtin University
Country [1] 288106 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987, Perth, WA, 6845
Country
Australia
Secondary sponsor category [1] 286825 0
None
Name [1] 286825 0
Address [1] 286825 0
Country [1] 286825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290028 0
Curtin University
Ethics committee address [1] 290028 0
Ethics committee country [1] 290028 0
Australia
Date submitted for ethics approval [1] 290028 0
09/10/2013
Approval date [1] 290028 0
15/10/2013
Ethics approval number [1] 290028 0

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

Contacts
Principal investigator
Name 43574 0
Dr Daniel Gucciardi
Address 43574 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U 1987
Perth, Western Australia 6845
Country 43574 0
Australia
Phone 43574 0
+61 8 9266 3653
Fax 43574 0
Email 43574 0
[email protected]
Contact person for public queries
Name 43575 0
Daniel Gucciardi
Address 43575 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U 1987
Perth, Western Australia 6845
Country 43575 0
Australia
Phone 43575 0
+61 8 9266 3653
Fax 43575 0
Email 43575 0
[email protected]
Contact person for scientific queries
Name 43576 0
Daniel Gucciardi
Address 43576 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U 1987
Perth, Western Australia 6845
Country 43576 0
Australia
Phone 43576 0
+61 8 9266 3653
Fax 43576 0
Email 43576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study discontinued for financial reasons.


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
No additional documents have been identified.