Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000072516
Ethics application status
Approved
Date submitted
22/12/2014
Date registered
28/01/2015
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
myMoves for Acquired Brain Injury (ABI): Feasibility and acceptability of an internet delivered self-management course to increase physical activity after Acquired Brain Injury
Scientific title
myMoves for ABI: Feasibility and acceptability of an internet delivered self-management course to increase physical activity in community-dwelling adults after Acquired Brain Injury
Secondary ID [1] 285886 0
Nil
Universal Trial Number (UTN)
U1111-1165-4834
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 293807 0
Stroke 293808 0
Traumatic Brain Injury 293809 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294110 294110 0 0
Physiotherapy
Stroke 294202 294202 0 0
Ischaemic
Injuries and Accidents 294203 294203 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention involves participation in the myMoves course - a course consisting of 6 Lessons delivered over an 8 week period. Lessons are delivered via the internet with support via telephone. The myMoves course aims to build the knowledge and skills required to self-manage physical activity levels over the long term. Lesson 1 consists of introductory material regarding ABI and physical activity. The Active Lifestyle Model is introduced - consisting of four elements - Managing Activity, Managing Barriers, Managing Expectations and Managing Habits. These four elements are the framework for the content of Lessons 2-5. Each element makes up the content of a Lesson. Lesson 6 is a summary of the course and provides information regarding relapse prevention. Each Lesson is accompanied by one Chapter of The Stories and a Worksheet. The Stories consist of the stories of 6 individuals which follow the participants through the course. The Worksheets are designed to help participants build the skills covered in each Lesson, such as problem-solving and challenging unrealistic expectations. Participants are supported via a telephone at least once per week. This will allow researchers to monitor adherence to the program, support participants in understanding content and building skills, and gain feedback on course materials and content. It is anticipated that participants will spend 2-4 hours per week on the course, including reading of materials, completing worksheets, discussion with myMoves team via telephone and email, and general consideration and application of course content and skills to their week. This time can be spread over the week as is convenient to the participant.
Intervention code [1] 290867 0
Behaviour
Intervention code [2] 290868 0
Lifestyle
Intervention code [3] 290939 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293906 0
Course satisfaction as measured with the Course Satisfaction Questionnaire - a purpose built questionnaire examining satisfaction with myMoves course
Timepoint [1] 293906 0
Post-treatment - that is week 9
Secondary outcome [1] 312129 0
Time spent being physically active (non-sedentary time) - measured with Actigraph and ActivPAL
Timepoint [1] 312129 0
Post-treatment - week 9. These devices are worn for 7 consecutive days.
Secondary outcome [2] 312130 0
Physical activity self-efficacy - using Physical Activity Self-Efficacy scale modified with permission from the SCI Exercise Self-Efficacy Scale (Kroll et al, 2007)
Timepoint [2] 312130 0
Post-treatment - week 9
Secondary outcome [3] 312131 0
Level of emotional distress (Kessler Scale of Psychological Distress) K-10
Timepoint [3] 312131 0
Post-treatment - week 9

Eligibility
Key inclusion criteria
Adults with non-degenerative Acquired Brain Injury
Living in the Australian Community
Able to walk outside for at least 50m without the assistance of another person
Able to read and understand written English
Access to the internet for the entire study duration
Have been seen by a medical practitioner within the last 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Degenerative neurological conditions
Undergone surgery within the last 6 months
Undergone treatment for cancer within the past 5 years
Scoring 30 or higher on the Kessler Psychological Distress Scale
Scoring less than 14/17 on the Telephone Assessed Mental State (TAMS)
Pregnant women

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants to respond to advertisements directing them to the myMoves website (www.mymoves.mq.edu.au). Participants to complete several brief online questionnaires and undergo a brief telephone interview to confirm eligibility. Participants provided with the opportunity to discuss the intervention, all questions answered. Consenting and eligible participants then provided with a start date.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data to be analysed for all time-points (pre, post and 3 months post intervention). Descriptive statistics used to describe sample demographics and characteristics. Repeated measures ANOVAs will be used to assess for differences in continuous data within the group over time (p-value <.05 for significance). Should differences be found, paired t-tests with Bonferroni corrections will be applied to evaluate changes within the group over each time period. If data is non-parametric then Wilcoxin sign-rank test will be applied instead. Categorical data will be assessed using McNemar's chi-square test. Correlational data to compare physical activity and sedentary behaviour measures using ActivPal and Actigraph GT3XE with actiity recall measure (MARCA) will be conducted using Spearman's rank correlation coefficient. All data analysis will be conducted using IBM SPSS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/12/2014
Actual
22/12/2014
Date of last participant enrolment
Anticipated
27/02/2015
Actual
17/02/2015
Date of last data collection
Anticipated
Actual
8/09/2015
Sample size
Target
40
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290469 0
University
Name [1] 290469 0
Macquarie University
Country [1] 290469 0
Australia
Primary sponsor type
Individual
Name
Taryn Jones
Address
Discipline of Physiotherapy, Department of Health Professions, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW 2109
Country
Australia
Secondary sponsor category [1] 289171 0
Individual
Name [1] 289171 0
Catherine Dean
Address [1] 289171 0
Discipline of Physiotherapy, Department of Health Professions, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW 2109
Country [1] 289171 0
Australia
Secondary sponsor category [2] 289238 0
Individual
Name [2] 289238 0
Julia Hush
Address [2] 289238 0
Discipline of Physiotherapy, Department of Health Professions, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW, 2109.
Country [2] 289238 0
Australia
Secondary sponsor category [3] 289239 0
Individual
Name [3] 289239 0
Blake Dear
Address [3] 289239 0
Department of Psychology, Suite 701, Building C3A, Macquarie University, North Ryde, NSW, 2109
Country [3] 289239 0
Australia
Secondary sponsor category [4] 289240 0
Individual
Name [4] 289240 0
Nickolai Titov
Address [4] 289240 0
Department of Psychology, C3A 701, Macquarie University, North Ryde, NSW, 2109
Country [4] 289240 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292138 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 292138 0
Ethics committee country [1] 292138 0
Australia
Date submitted for ethics approval [1] 292138 0
15/08/2014
Approval date [1] 292138 0
22/10/2014
Ethics approval number [1] 292138 0
5201400830

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

Contacts
Principal investigator
Name 53694 0
Ms Taryn Jones
Address 53694 0
Discipline of Physiotherapy, Department of Health Professions, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW 2109
Country 53694 0
Australia
Phone 53694 0
+61404036913
Fax 53694 0
Email 53694 0
[email protected]
Contact person for public queries
Name 53695 0
Taryn Jones
Address 53695 0
Discipline of Physiotherapy, Department of Health Professions, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW, 2109
Country 53695 0
Australia
Phone 53695 0
+61298509726
Fax 53695 0
Email 53695 0
[email protected]
Contact person for scientific queries
Name 53696 0
Catherine Dean
Address 53696 0
Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW, 2109
Country 53696 0
Australia
Phone 53696 0
+61298506621
Fax 53696 0
Email 53696 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
This was a study from 2014, and at this stage the sharing of data in this manner was not included within the ethics. De-identified data can be shared with ethical approval through contacting the author.


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.