Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001063404
Ethics application status
Approved
Date submitted
19/07/2016
Date registered
9/08/2016
Date last updated
17/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
myMoves for Seniors: Feasibility and acceptability of a remotely delivered self-management program to increase physical activity in seniors with a chronic health condition.
Scientific title
myMoves for Seniors: Feasibility and acceptability of a remotely delivered self-management program to increase physical activity in seniors with a chronic health condition.
Secondary ID [1] 289714 0
None
Universal Trial Number (UTN)
U1111-1185-5191
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic health conditions 299533 0
Physical inactivity 299534 0
Condition category
Condition code
Public Health 299512 299512 0 0
Health promotion/education
Physical Medicine / Rehabilitation 299515 299515 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention involves participation in the myMoves program - a self-management program consisting of 5 Lessons delivered over an 8 week period. Lessons are delivered via email with support from a physiotherapist via telephone and/or email. The myMoves program aims to build the knowledge and skills required to self-manage physical activity levels over the long term, and reduce sedentary behaviour. Lesson 1 consists of introductory material regarding physical activity, chronic health conditions and ageing. Lesson 2 focuses on understanding the FITT principles of physical activity (frequency, intensity, time and type), including how to increase and reduce activity levels as needed. Lesson 3 focuses on identifying barriers and building the skills of problem-solving and planning. Lesson 4 focuses on building sustainable activity habits. Lesson 5 focuses on prevention of relapse and summarises the program. 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 pacing of activity.

The program is tailored to individuals preferences. At the end of Lesson 1 individuals choose whether they want to focus on a program that aims to reduce sedentary behaviour and increase light physical activity (myMoves Up); increase levels of moderate physical activity (myMoves Fit); or a program focusing on improving functional strength (myMoves Strong). The program content (ie Lesson content and Case Stories) is then structured to focus on these specific areas. myMoves Up focuses on individuals making small changes in their everyday life to reduce both the overall time they spend sitting or lying, as well as breaking up prolonged bouts of sedentary behaviour. myMoves Fit focuses on individuals gradually increasing the amount of moderate physical activity they are doing over a week - with a focus on participation in activities that they enjoy and that fit with their lifestyle and ability. There is no set amount of activity prescribed as every individual will need to tailor their activity to suit their own situation and context, however the program does include education regarding the current physical activity guidelines set by the Australian Dept of Health and the World Health Organization. However, individuals will be encouraged to work towards these guidelines slowly and steadily. myMoves Strong will focus on building simple strengthening activities into daily living. Again, there is no program prescription as each individual needs will be different. Instead individuals will be supported to build their own strengthening program with small strengthening activities included in activities of daily living, for example, squats whilst packing the dishwasher and calf raises while brushing their teeth. Also, how activities such as climbing stairs and carrying shopping bags can be easily incorporated into a strengthening routine.

Participants are supported via a telephone and/or email 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 program materials and content. It is anticipated that participants will spend 2-4 hours per week on the program, including reading of materials, completing worksheets, discussion with myMoves team via telephone and email, and general consideration and application of program content and skills to their week. This time can be spread over the week as is convenient to the participant. It is anticipated that phone calls will be approximately 10 minutes in duration, with regular checking in with each call and/or email to see when and how the participant would like to be contacted next.

There is currently no software to monitor adherence, although this is anticipated to be a future development if future funding can be secured. Currently adherence is measured through self-report measures, including questionnaires regarding completion of lessons and duration.
Intervention code [1] 295345 0
Behaviour
Intervention code [2] 295346 0
Treatment: Other
Intervention code [3] 295347 0
Lifestyle
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298993 0
Feasibility of the myMoves program, which will be examined using a number of specific outcomes, of which one is:
Adherence to the intervention - examined via a purpose built questionnaire as to which Lessons were completed during the 8-week program time frame. This questionnaire was used with a previous iteration of this program for individuals with acquired brain injury.
Timepoint [1] 298993 0
The primary timepoint will be the week immediately following completion of the myMoves program (ie post-program - week 9).
Primary outcome [2] 298994 0
Feasibility of the myMoves program, which will be examined using a number of specific outcomes, of which one is:

Clinician time spent per participant – examined via data collected on the frequency and duration of contact with participants, including emails and telephone calls;
Timepoint [2] 298994 0
This outcome will be collected in the week throughout the entire study duration - commencing at the time of application and ceasing once all 3-month follow-up measures have been collected.
Primary outcome [3] 298995 0
Acceptability of the myMoves program: Assessed using the Program Satisfaction Questionnaire (PSQ), a purpose built questionnaire examining satisfaction with the myMoves program modelled from those used extensively by Macquarie University’s eCentreClinic. Participants will be asked to rate their overall satisfaction with the myMoves program on a 5-point scale with the following options: very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied. Participants will also be asked whether they felt the myMoves program was worth their time (yes or no), and whether they felt confident in recommending the myMoves program to other seniors with a chronic health condition (yes or no). Participants will also be invited to leave qualitative comments about the program.
Timepoint [3] 298995 0
This outcome will be collected in the week immediately following completion of the myMoves program, i.e. post-program (week 9).
Secondary outcome [1] 325835 0
Average daily time spent in light, and moderate to vigorous physical activity - measured with Actigraph and activPAL activity monitors worn for 7 consecutive days at each time point.
Timepoint [1] 325835 0
Data will be collected in the week prior to program commencement (i.e. pre-program or week 0), the week immediately following program completion (i.e. post-program or week 9) and at 3 months following program completion (i.e. 3-month follow-up).
Secondary outcome [2] 325836 0
Self-reported physical activity - measured using the Incidental and Planned Activity Questionnaire.
Timepoint [2] 325836 0
Data will be collected in the week prior to program commencement (i.e. pre-program or week 0), the week immediately following program completion (i.e. post-program or week 9) and at 3 months following program completion (i.e. 3-month follow-up).
Secondary outcome [3] 325837 0
Level of Fatigue - measured using the Fatigue Severity Scale
Timepoint [3] 325837 0
Data will be collected in the week prior to program commencement (i.e. pre-program or week 0), the week immediately following program completion (i.e. post-program or week 9) and at 3 months following program completion (i.e. 3-month follow-up).
Secondary outcome [4] 325838 0
Pain - measured using the Four-item Brief Pain Inventory
Timepoint [4] 325838 0
Data will be collected in the week prior to program commencement (i.e. pre-program or week 0), the week immediately following program completion (i.e. post-program or week 9) and at 3 months following program completion (i.e. 3-month follow-up).
Secondary outcome [5] 325839 0
Emotional wellbeing - measured using the Kessler Scale of Psychological Distress
Timepoint [5] 325839 0
Data will be collected in the week prior to program commencement (i.e. pre-program or week 0), the week immediately following program completion (i.e. post-program or week 9) and at 3 months following program completion (i.e. 3-month follow-up).

Eligibility
Key inclusion criteria
1. Aged 65 years or over;
2. Must have at least one chronic health condition (e.g. cardiovascular disease, arthritis, diabetes, osteoporosis);
3. Be currently living in the community within NSW, Australia;
4. Are able to walk for at least 10 mins outside without stopping and without assistance from another person (participants may use a walking aid);
5. Regular access to the Internet for the study duration;
6. To be able to read and understand written English;
7. Have been seen by their treating medical practitioner (GP or specialist) within the past 3 months.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those having undergone surgical intervention within the last 3 months;
2. Those with significant cognitive impairment as indicated by a score of less than 14/17 on the Telephone Assessed Mental State (TAMS).

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)
Allocation is not concealed
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
Not applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed from all participants at all pre-specified time points, pre-treatment, post-treatment and at 3 months following completion of the program. Descriptive statistics will be 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 (with a p-value of <.05 set for statistical 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 Wilcoxon sign-rank test will be applied instead. Categorical data will be assessed using McNemar’s chi-square test. Data analysis will also entail analysis of subgroups where specific outcomes are particularly pertinent to specific groups, e.g. individuals with low vs high levels of baseline physical activity. All data analysis will be conducted using IBM Statistical Package for Social Sciences (SPSS) version 22 for Mac.

As this is an initial feasibility and acceptability study, specific sample size calculations were not undertaken. The data collected form this study will be used to inform sample size calculations on secondary outcome data, such as physical activity outcomes, for future testing of the programs efficacy.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/08/2016
Actual
26/01/2017
Date of last participant enrolment
Anticipated
30/01/2017
Actual
15/05/2017
Date of last data collection
Anticipated
30/11/2017
Actual
Sample size
Target
60
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294091 0
Government body
Name [1] 294091 0
NSW Department of Family & Community Services
Country [1] 294091 0
Australia
Funding source category [2] 294092 0
University
Name [2] 294092 0
Macquarie University
Country [2] 294092 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Taryn Jones
Address
Suite 816, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW, 2109.
Country
Australia
Secondary sponsor category [1] 292924 0
University
Name [1] 292924 0
Macquarie University
Address [1] 292924 0
Balaclava Rd, North Ryde, NSW 2109
Country [1] 292924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295507 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 295507 0
Ethics committee country [1] 295507 0
Australia
Date submitted for ethics approval [1] 295507 0
12/07/2016
Approval date [1] 295507 0
22/08/2016
Ethics approval number [1] 295507 0
5201600530

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

Contacts
Principal investigator
Name 67546 0
A/Prof Taryn Jones
Address 67546 0
Department of Health Professions, Suite 816, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW 2109.
Country 67546 0
Australia
Phone 67546 0
+61404036913
Fax 67546 0
Email 67546 0
[email protected]
Contact person for public queries
Name 67547 0
Taryn Jones
Address 67547 0
Department of Health Professions, Suite 816, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW 2109.
Country 67547 0
Australia
Phone 67547 0
+61404036913
Fax 67547 0
Email 67547 0
[email protected]
Contact person for scientific queries
Name 67548 0
Taryn Jones
Address 67548 0
Department of Health Professions, Suite 816, Ground Floor, 75 Talavera Rd, Macquarie University, North Ryde, NSW 2109.
Country 67548 0
Australia
Phone 67548 0
+61404036913
Fax 67548 0
Email 67548 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
No additional documents have been identified.