Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001429347
Ethics application status
Approved
Date submitted
1/10/2017
Date registered
9/10/2017
Date last updated
22/10/2021
Date data sharing statement initially provided
4/03/2019
Date results provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a behavioural smartphone application decrease sedentary behaviour in cardiac rehabilitation?: the ToDo-CR feasibility study.
Scientific title
Can a behavioural smartphone application decrease sedentary behaviour in cardiac rehabilitation?: the ToDo-CR feasibility study.
Secondary ID [1] 293040 0
None
Universal Trial Number (UTN)
U1111-1202-9862
Trial acronym
ToDo-CR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary behaviour 304940 0
coronary heart disease 304941 0
Condition category
Condition code
Cardiovascular 304268 304268 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design
The feasibility study will be conducted over 6-months within the Canberra Hospital Cardiac Rehabilitation (CR) program. Participants will be assessed on admission and at the end of the 6-week traditional phase II hospital-based CR program. They will also complete a follow-up assessment post discharge from the CR program, approximately 6-months post admission to the CR program.

Intervention
On entry into the CR program, eligible participants will be given a Fitbit Flex, shown how to install the ToDo and Moves apps on their smartphone and how to use them by an exercise physiologist. Participants will be required to wear the Fitbit Flex for the 6-month study period and will be able to keep the Fitbit Flex on completion of the study.

ToDo is a cloud-based behaviour change service delivered through a smartphone application created by Onmi in collaboration with Do Something Limited and is currently being trialed in Europe. The ToDo program helps people learn new behaviours so they have more choice over how they react to different situations. The system suggests micro behavioural alternatives that gradually change people’s habits. This is based on evidence that these small behavioural changes effect health outcomes. Each program is personalised and consists of different types of Do’s: Core Do’s and Data Driven Do’s. CORE Do’s address the individual’s psychology and the factors that often prevent healthy changes. DATA DRIVEN Do’s, address their everyday context that traps them in habitual behaviour, fusing data from the Fitbit Flex (acceleration) and the Moves app (GPS) to create a comprehensive digital profile of the individual, with near real-time analysis algorithms.

At the intake of the program a set of diagnostic questions will be answered by the patient on the Do Something Different website. The unique program of behavioural prompts (Do’s) will be based on the person’s answers to the diagnostic questions. For a duration of one week baseline measurements will be collected. This is used to calibrate the program triggers for sending Data driven Do’s. The calibration uses absolute and relative behaviour (i.e. actual amount of steps and relative increases or decreases). The system computes variable scores based on the persons behaviour. When the system identifies a need for improvement, an appropriate Do is sent. By combining technology, evidence-based guidelines and psychology, the program aims to increase the patient’s self-efficacy, with the goal to decrease their sedentary behaviour and increase their moderate-vigorous physical activity.

Intervention code [1] 299263 0
Lifestyle
Intervention code [2] 299298 0
Treatment: Other
Intervention code [3] 299299 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303548 0
Sedentary behaviour. Sedentary behaviour will be measured using an accelerometer. The raw data collected by the accelerometer, counts, will be used to obtain the time spent in
sedentary behaviour, which will be defined as less than 100 counts per minute while awake..
Timepoint [1] 303548 0
baseline, 6 weeks and 4 months.
Primary outcome [2] 303603 0
Feasibility measures. This includes the standard deviation of the main outcome measure (sedentary behaviour) to estimate the sample size for a larger randomised controlled trial, the number of eligible participants, and the follow-up rates and response rates to questionnaires.
Timepoint [2] 303603 0
4 months.
Secondary outcome [1] 339303 0
Moderate - vigorous physical activity (MVPA; accelerometer). MVPA will be measured using an accelerometer. The raw data collected by the accelerometer, counts, will be used to obtain the time spent in different physical activity intensities while awake. We will use the Freedson Combination energy expenditure algorithm to determine the intensity cut-points.
Timepoint [1] 339303 0
baseline, 6 weeks and 4 months.
Secondary outcome [2] 339304 0
Body mass index (BMI). BMI (kg/m2) will be recorded using a calibrated set of scales and a stadiometer.
Timepoint [2] 339304 0
baseline, 6 weeks and 4 months.
Secondary outcome [3] 339305 0
Waist-to-hip ratio (WHR).Waist circumference and hip circumferences will be measured in centimetres
using a tape measure.
Timepoint [3] 339305 0
baseline, 6 weeks and 4 months.
Secondary outcome [4] 339306 0
Blood pressure. Blood pressure levels will be obtained using a mercury sphygmomanometer on the right
arm of seated subjects.
Timepoint [4] 339306 0
baseline, 6 weeks and 4 months.
Secondary outcome [5] 339307 0
Exercise Capacity.The 6-minute walk test (6MWT) is a commonly used objective measure of functional exercise capacity in cardiac rehabilitation. The distance an individual is able to walk along a flat 25-30 m walkway over a 6 minute period, with breaks as required, is recorded. The test is a self-paced, submaximal test of exercise capacity, and has been found to have a moderate-to-high reliability and validity.
Timepoint [5] 339307 0
baseline, 6 weeks and 4 months.
Secondary outcome [6] 339308 0
Health-related quality of life. The MacNew questionnaire will be used for the assessment of heart disease specifc health-related quality of life.
Timepoint [6] 339308 0
baseline, 6 weeks and 4 months.
Secondary outcome [7] 339309 0
Anxiety. The Hospital Anxiety and Depression Scale questionnaire will be used for the assessment of anxiety.
Timepoint [7] 339309 0
baseline, 6 weeks and 4 months.
Secondary outcome [8] 339310 0
Depression. The Hospital Anxiety and Depression Scale questionnaire will be used for the assessment of depression.
Timepoint [8] 339310 0
baseline, 6 weeks and 4 months.
Secondary outcome [9] 339311 0
Smartphone Application Usability. The Unified Theory of Acceptance and Use of Technology (UTAUT2) questionnaire will be used to assess the usability of the Vire DoCHANGE app and ToDo-CR program
Timepoint [9] 339311 0
4 months.
Secondary outcome [10] 339458 0
Sedentary behaviour (self-reported).Self-reported sedentary behaviour will be assessed using the Past-Day Adults’ Sedentary Time (PAST) questionnaire
Timepoint [10] 339458 0
baseline, 6 weeks and 4 months.
Secondary outcome [11] 339459 0
Moderate-vigorous physical activity (self-reported). Self-reported physical activity will be assessed using the Active Australia Survey.
Timepoint [11] 339459 0
baseline, 6 weeks and 4 months.

Eligibility
Key inclusion criteria
Attending a phase II (outpatient) cardiac rehabilitation program, with stable coronary heart disease and receiving optimal medical treatment +/- revascularisation, that is, coronary artery bypass graft surgery, percutaneous coronary intervention or another transcatheter procedure, or have had a myocardial infarction. Eligible participants must also have a smartphone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have New York Heart Association class II-IV symptoms of heart failure (or documented signs and symptoms of chronic heart failure, with ejection fraction < 45%), uncontrolled arrhythmias, severe chronic obstructive pulmonary disease, uncontrolled hypertension, symptomatic peripheral artery disease, unstable angina, uncontrolled diabetes, are unable to perform a submaximal walking test (6-minute walk test), or are unable to wear an accelerometer due to disability, for example, if they are confined to a wheelchair.

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)
No control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No control group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a feasibility study.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All participants who completed the baseline assessment and attended at least one session within the 6-week acrdiac rehabilitation (CR) program will be included in the evaluation sample. Quantitative analysis of outcome measures will be conducted. A p-value of less than 0.05 will be considered statistically significant. Qualitative thematic analysis of feedback from CR participants on the usage of the behavioural app (ToDo-CR) may be used.

The number of minutes per day spent in sedentary behaviour will be calculated using standard countbased intensity threshold values of counts per minute: < 100 for sedentary behaviour (<1.5 MET). Four
further summary measures of sedentary behaviours will calculated per day and averaged over valid days:
(a) percentage of the wear-day spent in sedentary behaviour (b) number of sedentary bouts (defined as a
period of consecutive minutes where the accelerometer registered <100 counts/minutes) (c) average duration of sedentary bouts and (d) number of sedentary breaks (defined as at least 1 min where the
accelerometer registered >= 100 counts/minute following a sedentary bout). The Freedson Combination
energy expenditure algorithm will be used to determine the intensity cut-points for MVPA. This outcome variable will be used to investigate whether participants have reached the World Health Organisation physical activity guidelines.

Additional analyses will be completed with a one-way repeated measures analysis of variance (ANOVA) to
test for differences in physical activity and sedentary behaviour (with a 95% confidence interval (CI)) within
the sample over 6 months. Intention-to-treat analysis will be used at 6-weeks, 6-months where data is missing, bringing the last value forward. A maximum of three attempts will be made to contact participants so outcome measures can be obtained, making the analysis more complete.

Sample size
As this project is a feasibility study a formal sample size calculation has not been completed. The aim is to recruit a minimum of 30 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/05/2018
Actual
14/01/2019
Date of last participant enrolment
Anticipated
30/04/2019
Actual
31/05/2019
Date of last data collection
Anticipated
30/10/2019
Actual
27/09/2019
Sample size
Target
30
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 9148 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 17659 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 297652 0
University
Name [1] 297652 0
University of Canberra
Country [1] 297652 0
Australia
Funding source category [2] 309989 0
Government body
Name [2] 309989 0
Australian Academy of Technology and Engineering Global Connections Fund Bridging Grant (BG 413436035)
Country [2] 309989 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Freene
Address
University of Canberra, University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 296674 0
Individual
Name [1] 296674 0
Sander van Berlo
Address [1] 296674 0
Onmi Design
Torenallee 30-10, Eindhoven, NL
Country [1] 296674 0
Netherlands
Secondary sponsor category [2] 296675 0
Individual
Name [2] 296675 0
Prof Rachel Davey
Address [2] 296675 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [2] 296675 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298736 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 298736 0
Ethics committee country [1] 298736 0
Australia
Date submitted for ethics approval [1] 298736 0
11/10/2017
Approval date [1] 298736 0
14/02/2018
Ethics approval number [1] 298736 0
ETH.10.17.230

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

Contacts
Principal investigator
Name 78062 0
Dr Nicole Freene
Address 78062 0
Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Country 78062 0
Australia
Phone 78062 0
+61 2 6201 5550
Fax 78062 0
Email 78062 0
[email protected]
Contact person for public queries
Name 78063 0
Nicole Freene
Address 78063 0
Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Country 78063 0
Australia
Phone 78063 0
+61 2 6201 5550
Fax 78063 0
Email 78063 0
[email protected]
Contact person for scientific queries
Name 78064 0
Nicole Freene
Address 78064 0
Physiotherapy
University of Canberra
University Drive
Bruce
ACT 2617
Country 78064 0
Australia
Phone 78064 0
+61 2 6201 5550
Fax 78064 0
Email 78064 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


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.