Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001223123
Ethics application status
Approved
Date submitted
15/08/2019
Date registered
4/09/2019
Date last updated
8/06/2021
Date data sharing statement initially provided
4/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Smartphone application-based behavioural intervention for cardiac rehabilitation and the effect on hospital readmissions: The ToDo-Cardiac Rehabilitation (ToDo-CR) randomised control trial
Scientific title
Smartphone application-based behavioural intervention for cardiac rehabilitation and the effect on hospital readmissions: The ToDo-Cardiac Rehabilitation (ToDo-CR) randomised control trial
Secondary ID [1] 299029 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ToDo-CR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 314038 0
sedentary behaviour 314040 0
Condition category
Condition code
Cardiovascular 312426 312426 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design-
The multi-centre, single jurisdiction, RCT will be conducted over 24-months in Canberra Cardiac Rehabilitation (CR) programs using staggered recruitment (the study duration for each individual participant is 12-months). Participants will be assessed on admission to traditional phase II hospital-based CR programs at The Canberra Hospital, Calvary Public Hospital Bruce and National Capital Private Hospital. After being assessed by CR staff, they will be randomly assigned to either routine CR alone (control group) or the intervention: CR complemented with the ToDo-CR program. Assessor blinding will be used throughout the study. A follow-up assessment at the University of Canberra will be completed at 6-months and 12-months post admission to the CR program. At 12-months, participants will complete a questionnaire regarding information about additional cardiac events, all cause hospital readmissions and visits to the emergency department since commencing CR. If able, this will be verified by hospital patient admission records accessed by CR staff to provide information regarding cardiac and/or all cause readmissions to hospital and visits to the emergency department.

Intervention- Arm 1 of RCT
Phase II hospital-based CR complimented with the the ToDo-CR program (intervention group):
Following entry into the CR program and baseline assessment, those randomised to the ToDo-CR program will be given a Fitbit, shown how to install the Fitbit and Vire DoACTIVE (Vire in short) application (app/s) on their smartphone and how to use them by the CR staff. These participants will be required to wear the Fitbit for the 12-month study period and will be able to keep the Fitbit on completion of the study. CR staff will provide the CR program as usual with no extra encouragement or support for these participants to decrease sedentary behaviour or increase physical activity during their 6-week CR program.

Vire and ToDo-CR are considered to be one intervention. The Vire app is used to deliver the ToDo-CR program. ToDo-CR is an online behaviour change service delivered through a smartphone app created by Onmi in collaboration with Do Something Limited. The ToDo-CR program used in this study will focus on the behavioural pillars ‘activity’ and ‘exercise’. The ToDo-CR program is designed to help people learn new behaviours so they have more choice over how they react to different situations. The system suggests micro behavioural alternatives (Do's) that gradually change people’s habits. This is based on evidence that these small behavioural changes effect health outcomes.
At the intake of the program a set of diagnostic questions will be answered by the patient on the Vire app. The unique program of behavioural prompts (Do’s) will be based on the person’s answers to the diagnostic questions. Each personalised program consists of different types of Do’s delivered through the smartphone app: Core Do’s and Data Driven Do’s.
Core Do’s address the individual’s psychology and the factors that often prevent healthy changes. These Do’s are selected based on intake questionnaires at the beginning of the program. For example, if a person responds that they spend most evenings watching TV or in front of a screen a lot of the time, the following Core Do may be sent: "SCREEN-FREE EVENING. Supercharge your evening - hit the Off button on TV/screens. Do something different e.g. play games, music, dance or phone a friend".
Data Driven Do’s, address their everyday context that traps them in habitual behaviour, fusing data from the Fitbit (acceleration) and Vire (GPS) to create a comprehensive digital profile of the individual, with near real-time analysis algorithms. For example, if the variety in acceleration and GPS data is low, the following Data Driven Do may be sent: "GO SOMEWHERE NEW. It's time for a change. Explore a new area on foot, or walk down a street you have never been on".
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 person's 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.
Vire also presents a 14-day overview. Here the patient can observe trends in their acceleration and GPS data showing their levels of activity, variety and social opportunity. This can help them to understand why a certain Do was dispatched in relation to why they may have been prompted to move more or try go somewhere different to usual. 

The ToDo-CR program will be delivered for 6-months, however, the Vire app (an interface to show daily activity, social opportunity and variety) will be available to the participants for the entire 12-months. Participants are required to try and engage with the Vire app and open their Fitbit app daily in order to generate data and get the most out of the ToDo-CR program over the 6-months of the intervention. A research team member (not involved in the data collection) will be able to access an online dashboard which indicates how frequently the users are interacting with the Vire app to monitor adherence to the intervention. If it is shown that a participant has not accessed the app in 3 days, they will be contacted by this member of the research team to obtain why this is and if their is a technical problem hindering the participant from engaging. This contact will cease at completion of the 6-month ToDo-CR program. Participants will also be sent a Do if they have not accessed their app or the Vire app has not been able to sync with the Fitbit app for 3 days. The purpose of the follow up measure at 12-months post commencing CR, is to then assess whether the ToDo-CR program helps facilitate sustained behaviour change.

Control- Arm 2 of RCT
Phase II hospital-based CR alone (control group).

Materials- smartphone, smartphone application (Vire DoACTIVE) which delivers the 6-month behaviour change program ToDo-CR, FitBits, ActiGraph triaxial commercial accelerometers, demographic questionnaire, Quality of Life questionnaire, anxiety and depression questionnaire, stage of behaviour change questionnaire, smartphone application usability questionnaire.
Intervention code [1] 315299 0
Prevention
Intervention code [2] 315300 0
Lifestyle
Intervention code [3] 315301 0
Behaviour
Comparator / control treatment
The participants assigned to routine CR alone group will act as the control group.
This involves them participating in the phase II hospital-based CR programs conducted at The Canberra Hospital, Calvary Public Hospital Bruce and National Capital Private Hospital. These hospitals follow Heart Foundation Guidelines for CR. These CR programs are typical of most contemporary programs in Australia, utilizing an approach that is multidisciplinary (i.e. nurses, physiotherapist/exercise physiologists), time limited (i.e. 5-6 weeks), conducted in groups, hospital-based and involves both educational and supervised exercise components (approximately one-hour each 1-2 times per week).

The control group will also be re-assessed at 6 and 12-months. The control group will be given a Fitbit on completion of the 12-month study.
Control group
Active

Outcomes
Primary outcome [1] 321078 0
Comparison of rates of cardiac-related and/or all cause hospital admissions and emergency department visits (intervention vs. control group). This is a composite primary outcome.
Participants will complete a questionnaire designed specifically for this study regarding information about additional cardiac events, all cause hospital readmissions and visits to the emergency department since commencing CR. If able, this information will be verified by hospital patient admission records accessed by CR staff to provide information regarding cardiac and/or all cause readmissions to hospital and visits to the emergency department.
Timepoint [1] 321078 0
Within the 12-months post commencing cardiac rehabilitation.
Secondary outcome [1] 373898 0
Sedentary behaviour objectively measured using an Actigraph accelerometer worn for 7-consecutive days while awake.
Timepoint [1] 373898 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [2] 373899 0
Anthropometrics- BMI
Weight will be measured by CR staff and suitably qualified research assistant using a calibrated scale with participants wearing no shoes or heavy outer clothing. Height will be measured using a stadiometer. Body mass index will then be calculated as the weight (kg) divided by the height squared (m2).
Timepoint [2] 373899 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [3] 373900 0
Exercise capacity- 6 minute walk test completed following standard protocol by CR staff and suitably qualified research assistant.
Timepoint [3] 373900 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [4] 373901 0
Assessment of Quality of Life (AQoL-6D)
Timepoint [4] 373901 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [5] 373902 0
Anxiety and depression- Hospital Anxiety and Depression Score (HADS)
Timepoint [5] 373902 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [6] 373903 0
Stage of exercise behaviour change (URICA-2)
Timepoint [6] 373903 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [7] 373904 0
Usability of the smartphone application (UTAUT2)
Timepoint [7] 373904 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [8] 374136 0
Moderate to vigorous physical activity levels objectively measured using an Actigraph accelerometer worn for 7-consecutive days while awake
Timepoint [8] 374136 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [9] 374137 0
Anthropometrics- waist circumference
The waist circumferences (cm) will be assessed by CR staff and suitably qualified research assistant using standard methods of a tape measure in line with the navel. Participants will be asked to remove bulky or excessive clothing to complete this measure.
Timepoint [9] 374137 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.
Secondary outcome [10] 374138 0
Economic evaluation using the AQoL-6D for economic assessment of health and medical services. This will be used to measure the cost of achieving an additional quality adjusted life year (QALY) and is calculated by multiplying life years by an index of utility measured on a 0-1 scale.
Timepoint [10] 374138 0
Within the 12-months post commencing cardiac rehabilitation- collected at baseline, 6-months and 12-months.

Eligibility
Key inclusion criteria
Participants will be eligible to take part in the study if they are aged 18+, are currently enrolled in the phase II CR programs at TCH, Calvary and NCPH and have a smartphone compatible with the apps.

Participants will be included if they have stable CHD and are receiving optimal medical treatment +/- revascularisation (i.e. coronary artery bypass graft surgery (CABG), percutaneous coronary intervention (PCI)), or have had a myocardial infarction (MI).

Eligible participants must have adequate language (English speaking) and vision to use/operate their smartphone. Participants must have adequate cognitive skills to agree to take part in the RCT, understanding what will be required of them. The CR staff will determine whether a participant has adequate cognitive skills to be involved in the study, assessing their level of understanding via methods such as getting the participants to repeat back what they are agreeing to and their understanding of the research project. No formal testing of cognition will take place.
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, or are unable to wear an accelerometer due to disability (e.g. if they are confined to a wheelchair). Participants will also be excluded if they have a pre-paid phone plan (limited data availability) or if the smartphone’s operating system is not compatible with all apps.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assessed for potential study inclusion on admission to the traditional phase II hospital-based cardiac rehabilitation programs. Randomised group status will be revealed to participants and clinical staff only after completion of baseline measures. The CR staff will email the central investigator (off site) once the baseline measure is done for a participant. They will then respond with the allocation so that the CR staff are able to either provide or not provide the participant with the intervention at their next CR session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computerised sequence generated with participants allocated on a 1:1 ratio to CR plus the behavioural smartphone app or CR alone (usual care).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation for the 2-armed study is based on a 28% difference in re-hospitalisation and emergency department visits between CR and CR plus a digital health intervention at 3 months following CR (Widmer et al., 2015). With a two-sided significance of p<0.05 and power of 90%, 110 participants are needed (55 in each group). Allowing for a 30% drop out rate over the follow up period based on our observational study (unpublished), 144 participants will be recruited (72 in each group) for the ToDo-CR RCT.

All participants who completed the baseline assessment and attended at least one session of the traditional phase II CR program will be included in the analysis. Statistical analysis will be carried out by the research team and an independent biostatistician. Specific details of the type of statistical analyses used for quantitative data will depend on normality. Data will be analysed according to group assignments, regardless of how many participants actually complete the study, the intent-to-treat principle. Participants will be contacted via telephone at 6-months and 12-months after commencing the CR program and asked to attend the University of Canberra for data collection. A maximum of four attempts will be made to contact participants that did not comply with the intervention protocols so outcome measures can be obtained, making the analysis more complete. If they are unable to attend at 6-months or 12-months, intention-to-treat analysis will be used and their last set of data values will be brought forward.

An intention-to-treat analysis may result in an underestimate of treatment effect, making it harder to find a significant difference. Therefore, data will be analysed using both intention-to-treat and on-protocol analyses to determine if the two methods yield the same or different results. This justifies the allowance of a 30% drop-out rate.

Significance level will be set at p < 0.05. All analyses will be conducted using SPSS or STATA.
 
The primary analysis for the RCT will use repeated measures analysis of covariance (ANCOVA). All analyses will be adjusted for baseline values. Additional covariates to be considered include: gender, age and employment status, an ordinal measurement.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
20/01/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
144
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 14555 0
The Canberra Hospital - Garran
Recruitment hospital [2] 14556 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [3] 14557 0
National Capital Private Hospital - Garran
Recruitment postcode(s) [1] 27571 0
2605 - Garran
Recruitment postcode(s) [2] 27572 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 303563 0
Government body
Name [1] 303563 0
Medical Research Future Fund (MRFF)
Country [1] 303563 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University of Canberra
University Drive,
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 303645 0
None
Name [1] 303645 0
Address [1] 303645 0
Country [1] 303645 0
Other collaborator category [1] 280906 0
Hospital
Name [1] 280906 0
The Canberra Hospital
Address [1] 280906 0
Yamba Drive (between Hindmarsh Drive and Kitchener St), Garran ACT 2605
Country [1] 280906 0
Australia
Other collaborator category [2] 280907 0
Hospital
Name [2] 280907 0
Calvary Public Hospital Bruce
Address [2] 280907 0
4 Mary Potter Circuit, Bruce ACT 2617
Country [2] 280907 0
Australia
Other collaborator category [3] 280908 0
Hospital
Name [3] 280908 0
National Capital Private Hospital
Address [3] 280908 0
Corner Gilmore Crescent & Hospital Road
Garran ACT 2605
Country [3] 280908 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304093 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 304093 0
PO Box 11 Woden ACT 2606
Ethics committee country [1] 304093 0
Australia
Date submitted for ethics approval [1] 304093 0
07/08/2019
Approval date [1] 304093 0
28/10/2019
Ethics approval number [1] 304093 0
2019.ETH.00162
Ethics committee name [2] 304098 0
Calvary Public Hospital Bruce Human Research Ethics Committee
Ethics committee address [2] 304098 0
Human Research Ethics Committee
Level 2, O’Shannassy Building
Mary Potter Cct,
Bruce ACT 2617
Ethics committee country [2] 304098 0
Australia
Date submitted for ethics approval [2] 304098 0
07/08/2019
Approval date [2] 304098 0
04/09/2019
Ethics approval number [2] 304098 0
20-2019 Behavioural interventions for cardiac rehabilitation: The ToDo-CR randomised control trial
Ethics committee name [3] 304762 0
University of Canberra Human Research Ethics Committee
Ethics committee address [3] 304762 0
University of Canberra
11 Kirinari Street
Bruce, ACT 2617
Ethics committee country [3] 304762 0
Australia
Date submitted for ethics approval [3] 304762 0
07/11/2019
Approval date [3] 304762 0
07/11/2019
Ethics approval number [3] 304762 0
2325

Summary
Brief summary
Cardiac rehabilitation (CR) is a secondary prevention program for cardiovascular disease with physical activity (PA) being a core component. Despite this, studies have found that PA levels are low and sedentary behaviour (SB) is high in CR patients. The aim of this randomised control trial (RCT) is: 1) to test the efficacy of a behavioural smartphone application (Vire DoACTIVE) and a 6-month online behaviour change program (ToDo-CR) in decreasing SB and increasing PA levels in CR participants (compared to routine CR alone); 2) to explore if this behavioural change intervention is effective at reducing the risk of repeat cardiac events, all cause hospital admissions and emergency department visits over 12-months post commencing CR. We propose to conduct a multi-centre RCT over 12-months with 144 participants from the Canberra Hospital, Calvary Public Hospital Bruce and National Capital Private Hospital CR programs. It is hypothesised that the intervention will increase PA levels, decrease SB and reduce repeat cardiac events, readmissions to hospital and emergency department visits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95794 0
Dr Nicole Freene
Address 95794 0
Physiotherapy, Rm 12D38
University of Canberra
University Drive
Bruce ACT 2617
Country 95794 0
Australia
Phone 95794 0
+61 417712386
Fax 95794 0
Email 95794 0
[email protected]
Contact person for public queries
Name 95795 0
Miss Kacie Patterson
Address 95795 0
University of Canberra
University Drive
Bruce ACT 2617
Country 95795 0
Australia
Phone 95795 0
+61 432486625
Fax 95795 0
Email 95795 0
[email protected]
Contact person for scientific queries
Name 95796 0
Miss Kacie Patterson
Address 95796 0
University of Canberra
University Drive
Bruce ACT 2617
Country 95796 0
Australia
Phone 95796 0
+61 432486625
Fax 95796 0
Email 95796 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
SourceTitleYear of PublicationDOI
EmbaseA smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions: The ToDo-CR randomised controlled trial study protocol.2020https://dx.doi.org/10.1136/bmjopen-2020-040479
EmbaseTesting the Effect of a Smartphone App on Hospital Admissions and Sedentary Behavior in Cardiac Rehabilitation Participants: ToDo-CR Randomized Controlled Trial.2023https://dx.doi.org/10.2196/48229
N.B. These documents automatically identified may not have been verified by the study sponsor.