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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]

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

sedentary behaviour

Condition category

Condition code

Cardiovascular

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Within the 12-months post commencing cardiac rehabilitation.

Secondary outcome [1]

Sedentary behaviour objectively measured using an Actigraph accelerometer worn for 7-consecutive days while awake.

Timepoint [1]