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Trial registered on ANZCTR


Registration number
ACTRN12618001458224
Ethics application status
Approved
Date submitted
24/08/2018
Date registered
30/08/2018
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM): A 21st Century Approach for Improving the Self-Management of Heart Disease
Scientific title
Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM): A Multi-centre, investigator blinded, parallel group randomised controlled trial comparing the effects and costs of cardiac telerehabilitation with usual care for people with coronary heart disease
Secondary ID [1] 294049 0
None
Universal Trial Number (UTN)
U1111-1209-3619
Trial acronym
SCRAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 306596 0
Condition category
Condition code
Cardiovascular 305689 305689 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 305690 305690 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
OVERVIEW
Participants randomised to the intervention arm will receive 24 weeks of usual care cardiac rehabilitation plus the 24-week Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) program.

USUAL CARE CARDIAC REHABILITATION
Usual care typically includes support and education to adhere to medical treatment and health-promoting lifestyle behaviours; some healthcare providers also offer supervised exercise programs. Specific service provision to individual participants may vary depending on their geographic location, in line with the services offered by their local healthcare provider. Access to usual care will be self-initiated.

As no medication will be administered participants will be free to take any medications they have been prescribed. Medication use will be recorded at baseline, including generic medication names, initial prescription dates, and frequencies of administration. Changes to prescribed medications during the treatment period will be recorded at follow-up as required.

SCRAM PROGRAM
SCRAM is a dual-phase tailored intervention that comprises remotely supervised exercise training plus evidence- and theory-based behaviour change and education support to optimise self-management of cardiovascular risk factors. SCRAM will be delivered via a bespoke telerehabilitation platform that includes a participant-facing smartphone application, cardiac rehabilitation specialist-facing web application, and cloud-based data management system. SCRAM aims to support individuals to exercise, adhere to prescribed medications, make relevant health-promoting lifestyle changes, and educate them about their modifiable cardiovascular risk factors. Recommended lifestyle changes include regular exercise, decreasing salt, saturated fat and alcohol consumption, and increasing fruit and vegetable consumption.

SCRAM includes a 12 week initiation phase followed by a 12 week maintenance phase. The initiation phase will provide intensive support to engage in exercise and lifestyle behaviour change to improve cardiovascular risk factor profile. The maintenance phase will provide lower intensity support designed to assist participants' transition towards independent exercise and self-management behaviours, and promote long-term adherence to health behaviour changes.

Exercise training: Initiation Phase (weeks 1-12)
At preferred times during pre-defined operating hours, participants will use the bespoke SCRAM telerehabilitation platform to connect with a remotely-located exercise physiologist to receive real-time exercise supervision and coaching. Participants will self-fit a wearable sensor (Zephyr BioHarness 3, worn around the chest) and activate the SCRAM smartphone app to transmit physiological (single lead ECG, heart rate, respiratory rate) and geospatial data (location, distance, speed, elevation, gradient) to exercise physiologists in real-time. Participants will receive real-time coaching, feedback, and support from exercise physiologists (see below), delivered as audio notifications via the SCRAM smartphone app. Participants will be recommended to use earphones to optimise the audio notification user experience, but messages will also be audible via integrated smartphone speaker(s) if required. Participants will use the SCRAM app for “offline” self-monitoring of exercise performance and CVD risk factors, goal setting and reviewing goal achievement feedback, and to receive evidence- and theory-based behavioural change support content via direct messages. All intervention group participants will complete a bespoke training module, receive an illustrated user guide, and have access to technical support via email and/or telephone if required. Participants will be loaned a smartphone if required and receive a voucher to cover mobile broadband costs.
Exercise physiologists will use the SCRAM web app to monitor participants’ location, distance, speed, heart rate, single lead ECG, and self-reported cardiac symptoms (if relevant) in realtime throughout exercise. These features will support optimal individualisation and progression of exercise prescription throughout the 12-week intensive intervention phase. Exercise physiologists will also use the web app to provide participants with regular coaching instruction, feedback and support during exercise. Coaching interactions will be delivered to participants via the SCRAM smartphone app as audio alerts, instant/direct messages, push notifications, and/or telephone calls. Participants can be monitored in any environment with an active Wi-Fi or 3G/4G broadband connection, and the platform supports simultaneous monitoring of multiple participants. Exercise physiologists will receive comprehensive training to deliver these intervention components.
Exercise physiologists will provide participants with an individualised exercise prescription based on their clinical status, exercise capacity, exercise-induced cardiac signs and symptoms (if any), age, sex, and personal preferences. Prescription will follow ACSM guidelines for cardiac populations. Exercise frequency, duration, intensity level (percentage of heart rate reserve [%HRR]) targets will be delivered via the SCRAM smartphone app. Initial prescription will target 3 sessions per week of 30–40 minutes duration at 40–50%HRR. Exercise prescription parameters will be increased progressively according to participants’ exercise tolerance, signs and symptoms, and clinical status, and will target 3–5 weekly sessions of 60 minutes at 65–85%HRR. Prescribed exercise intensity will be sufficient to induce physiological adaptation while remaining below a metabolic load that evokes abnormal clinical signs or symptoms. All exercise training sessions will include warm up and cool down phases to enable appropriate cardiovascular and musculoskeletal preparation and recovery. The preferred mode of exercise will be walking, although participants are able to choose other modes (e.g. cycling, rowing) in line with their preferences and access to requisite exercise equipment.

Exercise training: Maintenance Phase (weeks 13-24)
SCRAM participants will receive lower intensity support from exercise physiologists during the maintenance phase. Participants will be encouraged to continue to quantify their exercise performance using the SCRAM smartphone app and wearable sensor throughout; however, they will not receive real-time supervision and coaching from exercise physiologists. Participants will be able to view real-time performance data via the SCRAM smartphone app during exercise training, and review individualised summary statistics and goal achievement feedback outside of exercise training to support self-monitoring.
Exercise physiologists will undertake regular retrospective review of participants’ recorded exercise adherence and performance data—via the SCRAM web app—to inform individualised feedback and modification of exercise prescription as required. Non-adherence will initiate prompts via the app (alerts, direct messages, and/or push notification) to promote engagement.

Self-management behavioural sport: Initiation Phase (weeks 1-12)
SCRAM participants will receive evidence- and theory-based self-management strategies to facilitate lifestyle behaviour change initiation and adherence-via the SCRAM smartphone app-in the form of instant/direct messages and/or push notifications. Content will include information and cognitive (e.g. goal setting, barrier resolution), behavioural (e.g. self-monitoring) and environmental (e.g. leveraging social support) strategies to support general heart health, physical activity, diet, reducing alcohol consumption, medication adherence, and (if indicated) smoking cessation. Content may be in the form of text, audio, still or moving image, and/or web-linked content. Self-management support will be delivered 4–5 times per week during the initiation phase. Some interactions will include prompts or cues to action, others will involve theory-and evidenced-based strategies to initiate and maintain health behaviour change.

Self-management behavioural sport: Maintenance Phase (weeks 13-24)
Self-management support, as described above, will be delivered 2–3 times per week during the maintenance phase. Content will emphasise behavioural strategies that promote long term adherence including autonomy, self-directed motivation and relapse prevention.
Intervention code [1] 312057 0
Rehabilitation
Intervention code [2] 312058 0
Lifestyle
Intervention code [3] 312059 0
Behaviour
Comparator / control treatment
OVERVIEW
Participants randomised to the control arm will receive 24 weeks of usual care cardiac rehabilitation alone, without additional support.

USUAL CARE CARDIAC REHABILITATION
Usual Care typically includes support and education to adhere to medical treatment and health-promoting lifestyle behaviours; some healthcare providers also offer supervised exercise programs. Specific service provision to individual participants may vary depending on their geographic location, in line with the services offered by their local healthcare provider. Access to usual care will be self-initiated.

As no medication will be administered participants will be free to take any medications they have been prescribed. Medication use will be recorded at baseline, including generic medication names, initial prescription dates, and frequencies of administration. Changes to prescribed medications during the treatment period will be recorded at follow-up as required.
Control group
Active

Outcomes
Primary outcome [1] 307003 0
Maximal cardiorespiratory fitness (VO2max)
Timepoint [1] 307003 0
24 weeks
Secondary outcome [1] 350327 0
Blood glucose concentration. Capillary sample, point of care analyser. Fasted for at least 3 h, measured prior to VO2max test (primary outcome)
Timepoint [1] 350327 0
6 months
Secondary outcome [2] 350328 0
Blood pressure: resting systolic and diastolic.
Standardised measurement protocol using a calibrated, automatic sphygmomanometer after at least 5 minutes of seated rest. Measured prior to VO2max test
Timepoint [2] 350328 0
6 months
Secondary outcome [3] 350329 0
Physical Activity: Godin Leisure Time Physical Activity Questionnaire
Timepoint [3] 350329 0
3 and 6 months
Secondary outcome [4] 350330 0
Alcohol consumption: Weekly standard units consumed, assessed using the 3-item Audit-C questionnaire
Timepoint [4] 350330 0
3 and 6 months
Secondary outcome [5] 351163 0
Dietary behaviour: ASA24 automated self-administered recall
Timepoint [5] 351163 0
3 and 6 months
Secondary outcome [6] 351164 0
Medication adherence: Morisky 8-item Medication Adherence Questionnaire
Timepoint [6] 351164 0
3 and 6 months
Secondary outcome [7] 351165 0
Health-related quality of life: AQoL-8D. Quality-adjusted life year (QALY) gains will be calculated if a between-group difference in health-related quality of life is detected.
The derived preference index will be used in the economic evaluation (see below)
Timepoint [7] 351165 0
3 and 6 months
Secondary outcome [8] 351166 0
Exercise Adherence: Number of CR exercise training sessions completed relative to the number prescribed during the treatment programme.
Control group: assessed by auditing attendance logs at usual care CR centres if participants self-report having enrolled in a usual care exercise rehabilitation programme.
Intervention group: assessed via data captured by the SCRAM telerehabilitation platform, and by auditing attendance logs at usual care CR centres if participants self-report having concurrently enrolled in a usual care exercise rehabilitation programme.
Timepoint [8] 351166 0
3 and 6 months
Secondary outcome [9] 351167 0
Adverse events: Self-reported changes to health status of any kind, e.g. musculoskeletal injury, hospitalisation, acute illness not requiring hospitalisation.
Timepoint [9] 351167 0
3 and 6 months
Secondary outcome [10] 351168 0
Economic evaluation: Costs of programme delivery; health service utilisation (extracted with consent from Medicare Benefits Schedule records); medication utilisation (extracted with consent from Pharmaceutical Benefits Schedule records); and participant costs.
The incremental cost-effectiveness ratio will be calculated if a between-group difference in health-related quality of life is detected
Timepoint [10] 351168 0
6 months
Secondary outcome [11] 351169 0
Process evaluation: Semi-structured exit interviews with a subsample of participants to understand intervention barriers, facilitators, program engagement and uptake, as well as program usability and acceptability.
Smartphone app usage data will also be collected for participants in the intervention group
Timepoint [11] 351169 0
6 months
Secondary outcome [12] 351274 0
Total cholesterol concentration. Capillary sample, point of care analyser. Fasted for at least 3 h, measured prior to VO2max test (primary outcome)
Timepoint [12] 351274 0
6 months
Secondary outcome [13] 351275 0
LDL cholesterol concentration. Capillary sample, point of care analyser. Fasted for at least 3 h, measured prior to VO2max test (primary outcome)
Timepoint [13] 351275 0
6 months
Secondary outcome [14] 351276 0
HDL cholesterol concentration. Capillary sample, point of care analyser. Fasted for at least 3 h, measured prior to VO2max test (primary outcome)
Timepoint [14] 351276 0
6 months
Secondary outcome [15] 351277 0
Triglyceride concentration. Capillary sample, point of care analyser. Fasted for at least 3 h, measured prior to VO2max test (primary outcome)
Timepoint [15] 351277 0
6 months
Secondary outcome [16] 351279 0
Body mass. Digital scale
Timepoint [16] 351279 0
6 months
Secondary outcome [17] 351280 0
Body mass index. Digital scale + stadiometer
Timepoint [17] 351280 0
6 months
Secondary outcome [18] 351281 0
Waist circumference. Tape measure
Timepoint [18] 351281 0
6 months
Secondary outcome [19] 351282 0
Hip circumference. Tape measure
Timepoint [19] 351282 0
6 months

Eligibility
Key inclusion criteria
Eligible participants will be aged 18+ years; have diagnosed ischaemic heart disease within the previous six months (angina, myocardial infarction, or coronary revascularisation); outpatients who have been clinically stable for at least 6 weeks; and can understand and write English.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have New York Heart Association class III/IV heart failure; terminal disease; an implanted pacemaker or automated defibrillator, significant non-ischaemic heart disease exercise limitations; or contraindications for maximal exercise testing.

Smartphone ownership is not required, a loan phone will be available for intervention participants for the duration of the trial if necessary.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by a central computerised system (REDCap randomisation module) until the completion of baseline assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified (sex, study centre) blocked randomisation schedule will be prepared by a statistician who will not be involved with recruitment, treatment allocation, or outcome assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Our previous research indicates 174 participants are required to detect a clinically meaningful difference of 2.0 ml/kg/min in VO2max (primary outcome) between groups at 24 weeks with 90% statistical power at a 5% significance level (two-sided). This estimate assumes a standard deviation of 6.75 ml/kg/min and a correlation of r = 0.80 between repeated measures. Allowing for 20% loss to follow-up (17% in our previous trial), 220 participants (110 per treatment arm) will be required.

The difference in primary outcome effect size was chosen because it is consistent with our previous trial as well as other research, and is associated with lower CV-mortality.
Using estimates from our previous trial and other pilot data, this sample size will provide at least 80% statistical power to detect minimum between-group differences of 0.21 mmol/L in total cholesterol concentration, 0.16 mmol/L in LDL concentration, 0.10 mmol/L HDL concentration, 0.29 mmol/L in triglyceride concentration, 4.7 mm Hg in SBP, 2.7 mm Hg in DBP, 303 min/week in total physical activity, 83 min/week in leisure-time physical activity, 0.023 in HRQOL, 0.3 serves/day in vegetable consumption, and 0.51 in medication adherence at 24-week follow-up.

A separate Statistical Analysis Plan will include full details of all analytical approaches. Briefly, baseline demographics and clinical characteristics will be descriptively summarised by treatment group. A linear regression model of VO2max at 24 weeks will be fitted to assess between-group differences in the primary outcome, adjusted for baseline values and stratification variables (sex, study centre). Primary analyses will be performed on the principle of intention-to-treat. Multiple imputations will be used on the primary outcome with missing data, followed by sensitivity analyses under different assumptions to test the robustness of treatment effects. A per-protocol analysis may be conducted to test treatment effects among participants who complete follow-up. Secondary analyses will adjust the regression model for other baseline prognostic factors (e.g. age, employment status). A similar approach will be used to assess treatment group differences in continuous secondary outcomes; logistic regression and Poisson regression will be used for binary and count outcomes, respectively.
Model adjusted estimates and group differences will be reported with 95% confidence intervals and associated probability values. Sensitivity analyses will also be reported. All statistical tests will be two-sided at the 5% level of significance.

The Biostatistician will not be granted access to identifiable or treatment allocation data to ensure they remain blinded during analysis of treatment effects.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11585 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 11586 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 11587 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 23629 0
3021 - St Albans
Recruitment postcode(s) [2] 23628 0
3220 - Geelong
Recruitment postcode(s) [3] 23630 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 298674 0
Government body
Name [1] 298674 0
National Health and Medical Research Foundation
Address [1] 298674 0
GPO Box 1421
Canberra ACT 2601
Country [1] 298674 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Locked Bag 20000
Geelong VIC 3220
Australia
Country
Australia
Secondary sponsor category [1] 297844 0
None
Name [1] 297844 0
Address [1] 297844 0
Country [1] 297844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299628 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299628 0
Research Governance and Ethics Office for Research
Melbourne Health
Level 2 South-West, 300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 299628 0
Australia
Date submitted for ethics approval [1] 299628 0
23/04/2018
Approval date [1] 299628 0
26/06/2018
Ethics approval number [1] 299628 0
HREC/18/MH/119

Summary
Brief summary
We developed a smartphone-based cardiac rehabilitation programme that provides participants with 1) real-time exercise monitoring and coaching from rehabilitation specialists, and 2) educational and social support to make heart healthy lifestyle changes, regardless of where they live. This overcomes key accessibility issues that stop many people participating in traditional hospital-based programmes..
This study will compare health effects and costs of smartphone-based and traditional rehabilitation programmes. We expect the accessibility of the smartphone-based programme will increase participation, improve health outcomes, and reduce costs.



Exercise training is a central component of global guidelines for the secondary prevention of ischaemic heart disease and traditional programs delivered in face-to-face settings result in numerous health and wellness benefits. However, uptake and adherence to these programs is low. Accessibility barriers are among the key factors limiting participation rates, especially in regional and rural areas. Our trial will assess the effectiveness of a telerehabilitation program that uses mobile and internet technologies to emulate face-to-face exercise supervision and coaching, and deliver education and strategies to support healthy lifestyle behaviours. 220 participants will receive 1) 24 weeks of usual care (i.e. face-to-face) cardiac rehabilitation or 2) 24 weeks of telerehabilitation in addition to usual care. We will compare physical fitness, risk factors associated with heart disease, lifestyle behaviours, program adherence, and costs between these two groups. This telerehabilitation delivery model has potential to improve the reach and accessibility of cardiac rehabilitation services, and satisfy the unique preferences of many people who are currently unable or unwilling to attend face-to-face programs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81090 0
Prof Ralph Maddison
Address 81090 0
Institute for Physical Activity and Nutrition
Deakin University
Locked Bag 20000
Geelong VIC 3220
Country 81090 0
Australia
Phone 81090 0
+ 61 3 924 46218
Fax 81090 0
Email 81090 0
ralph.maddison@deakin.edu.au
Contact person for public queries
Name 81091 0
Dr Jonathan Rawstorn
Address 81091 0
Institute for Physical Activity and Nutrition
Deakin University
Locked Bag 20000
Geelong VIC 3220
Country 81091 0
Australia
Phone 81091 0
+61 3 92468461
Fax 81091 0
Email 81091 0
jonathan.rawstorn@deakin.edu.au
Contact person for scientific queries
Name 81092 0
Dr Jonathan Rawstorn
Address 81092 0
Institute for Physical Activity and Nutrition
Deakin University
Locked Bag 20000
Geelong VIC 3220
Country 81092 0
Australia
Phone 81092 0
+61 3 92468461
Fax 81092 0
Email 81092 0
jonathan.rawstorn@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests for all de-identified individual participant data will be considered, as per below.
When will data be available (start and end dates)?
Following trial completion and publication (no date currently available)
Available to whom?
Requests will be considered where the proposed use complies with trial ethical approval, does not conflict with planned use by the trial steering committee or other external data requests, aligns with public good purposes, and the requestor is willing to sign a data access agreement
Available for what types of analyses?
Requests will be considered where the proposed use complies with trial ethical approval, does not conflict with planned use by the trial steering committee or other external data requests, aligns with public good purposes, and the requestor is willing to sign a data access agreement
How or where can data be obtained?
Please contact the Coordinating Principal Investigator listed elsewhere in this registration
What supporting documents are/will be available?
No other documents available
Summary results
No Results