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Trial registered on ANZCTR


Registration number
ACTRN12616000426482
Ethics application status
Approved
Date submitted
30/03/2016
Date registered
4/04/2016
Date last updated
4/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes: A Randomized Controlled Trial Protocol [SMART-REHAB Trial]
Scientific title
SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes: A Randomized Controlled Trial Protocol [SMART-REHAB Trial]
Secondary ID [1] 288885 0
Nil known
Universal Trial Number (UTN)
U1111-1181-4032
Trial acronym
SMART-REHAB Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 298185 0
Myocardial Infarction 298186 0
Condition category
Condition code
Cardiovascular 298349 298349 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 298371 298371 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The smartphone-based secondary prevention program will be delivered over 8 weeks starting at time of discharge from hospital through a smartphone application (app). This is a multi-faceted intervention with particular emphasis on early mobilization. The app provides a platform to deliver a comprehensive secondary prevention program. The different components of the program are:

1. Exercise Prescription - Patients will have access to real-time feedback of their activity levels through the app’s activity tracker which links to the smartphone’s accelerometer feature. Patients will be able to monitor the number of steps taken and the distance walked. Patients will undertake a graded walking program increasing in time and intensity over the 8 weeks. Patients will increase their daily steps by 1,000steps a week until they reach 10,000 steps.
2. Dynamic tracking of cardiovascular risk factors - Patients will have an interactive personal dashboard highlighting the status of their cardiovascular risk factors. Blood pressure, cholesterol levels, glucose levels, weight, smoking status will be graded depending whether they are at recommended target levels.
3. Dietary Habits - Dietary habits will be tracked through the app via access to the phone’s inbuilt camera. Patients will be encouraged to photograph the food they consume.
4. Cardiac Education - Two educational messages per week will be delivered to the participants as they progress through the 8-week SSPP.
5. Cardiac Medication List - Patients will input their discharge medications into the app prior to leaving hospital. The medication list will be reviewed to ensure that appropriate evidence-based pharmacotherapy (dual antiplatelet therapy, statin, angiotensin converting enzyme inhibitor/angiotensin receptor blocker, beta-blocker) has been prescribed.
6. Interactive and Personalized Feedback -Patients will receive five personalized messages per week via the app messaging service. Two of the messages will be educational and the remaining three messages provide goal setting feedback on physical activity levels and diet.
7. Support - The messaging service also allows the patient to initiate contact if they have any questions regarding their cardiac condition or rehabilitation process.

Adherence will be measure by number of times a patient logs into app.
Intervention code [1] 294343 0
Rehabilitation
Comparator / control treatment
Control group is assigned to usual post-discharge acute coronary syndrome care which includes traditional cardiac rehabilitation
Control group
Active

Outcomes
Primary outcome [1] 297817 0
Change in exercise capacity as measure by change in six-minute walk test distance from baseline to 8-week assessment.
Timepoint [1] 297817 0
Baseline and 8-weeks.
Secondary outcome [1] 322343 0
Change in BP measured by digital sphygmomanometry.
Timepoint [1] 322343 0
Baseline and 8-weeks
Secondary outcome [2] 322399 0
Change in total cholesterol measured by serum assay.
Timepoint [2] 322399 0
Baseline and 8-weeks
Secondary outcome [3] 322401 0
Change in weight measure on scale.
Timepoint [3] 322401 0
Baseline and 8-weeks
Secondary outcome [4] 322402 0
Change in waist circumference measured by tape measure.
Timepoint [4] 322402 0
Baseline and 8-weeks
Secondary outcome [5] 322403 0
Smoking status assessed by self-report.
Timepoint [5] 322403 0
8-weeks
Secondary outcome [6] 322404 0
Adherence to secondary prevention pharmacotherapy by pill-count on drug packet.
Timepoint [6] 322404 0
8-weeks
Secondary outcome [7] 322405 0
Major adverse cardiovascular events (combination of death, mortality, stroke and unplanned revascularisation) verified by review of medical records.
Timepoint [7] 322405 0
8-weeks
Secondary outcome [8] 322406 0
Depression assessed by the cardiac depression scale and depression scale-short form
Timepoint [8] 322406 0
8 weeks
Secondary outcome [9] 322407 0
Anxiety assessed by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [9] 322407 0
8 weeks
Secondary outcome [10] 322408 0
Change in quality of life assessed by SF-36 questionnaire
Timepoint [10] 322408 0
Baseline and 8-weeks
Secondary outcome [11] 322409 0
Quality of adjusted life years as calculated by EQ-5D
Timepoint [11] 322409 0
8 weeks
Secondary outcome [12] 322410 0
Hospital readmissions verified by medical records.
Timepoint [12] 322410 0
8 weeks
Secondary outcome [13] 322451 0
Change in LDL-cholesterol measured by serum assay.
Timepoint [13] 322451 0
Baseline and 8-weeks.
Secondary outcome [14] 322452 0
Change in HDL-cholesterol measured by serum assay.
Timepoint [14] 322452 0
Baseline and 8-weeks
Secondary outcome [15] 322453 0
Change in triglycerides as measured by serum assay.
Timepoint [15] 322453 0
Baseline and 8-weeks.

Eligibility
Key inclusion criteria
Acute coronary syndromes with documented coronary artery disease
Smartphone ownership
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Untreated ventricular tachycardia
* Severe heart failure
* Significant residual coronary artery disease requiring revascularisation
* treatment with coronary artery bypass surgery
* life-threatening coexisting disease with life-expectancy less than 1 year
* significant exercise limitations for reasons other than CHD.

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)
Eligible patients will be randomized in a 1:1 fashion to smartphone based secondary prevention program or usual care through a computerized randomization program. Randomization will be stratified by study site and be overseen by the Centre of Cardiovascular Research and Education in Therapeutics; an independent research body within the School of Public Health and Preventive Medicine at Monash University (Melbourne, Australia). Assessors of the primary outcomes are blind to treatment allocation; however participants are not blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation stratified by study site.
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
Efficacy
Statistical methods / analysis
We calculate a sample size of 152 participants (76 per group) will be required to detect a minimal clinically important difference of 25 metres for the six-minute walk test in patients with ACS with 80% power at 5% level of significance. This is based on a mean (SD) six-minute walk test distance of 480 (104). Accounting for 20% loss to follow-up rate we will aim to recruit 100 patients in each arm.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
30/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5516 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 5517 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 5518 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 5519 0
Western Hospital - Footscray
Recruitment hospital [5] 5520 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [6] 5521 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [7] 5522 0
The Alfred - Prahran

Funding & Sponsors
Funding source category [1] 293235 0
Charities/Societies/Foundations
Name [1] 293235 0
National Heart Foundation of Australia
Country [1] 293235 0
Australia
Funding source category [2] 293238 0
Government body
Name [2] 293238 0
Victorian Cardiac Clinical Network
Country [2] 293238 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 292052 0
None
Name [1] 292052 0
Address [1] 292052 0
Country [1] 292052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294715 0
Austin Health Human Ethics Committee
Ethics committee address [1] 294715 0
145 Studley Road
PO BOX 5555
Heidelberg VIC 3084
Ethics committee country [1] 294715 0
Australia
Date submitted for ethics approval [1] 294715 0
02/02/2015
Approval date [1] 294715 0
02/07/2015
Ethics approval number [1] 294715 0
HREC/15/Austin/128

Summary
Brief summary
Aim

The aim of this trial is to assess the impact of a smartphone-based secondary prevention program, initiated on discharge in patients with acute coronary syndromes, on exercise capacity, cardiovascular risk factors, quality of life and mood.

Hypothesis
The primary hypothesis is that a smartphone-based secondary prevention program would improve exercise capacity, as measure by a 6-minute walk test, compared to standard care. Secondary hypotheses are: A smartphone-based secondary prevention program will result in earlier return to work and improvement in cardiac depression and quality of life scores. It is also hypothesized that there will an improvements in cardiovascular risk factors (lipid profile, blood pressure, HbA1C, anthropometry) and secondary prevention pharmacotherapy use between the groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64794 0
Dr Matias Yudi
Address 64794 0
Austin Health
Cardiology Department
145 Studley Road
PO BOX 5555
Heidelberg, VIC 3084
Country 64794 0
Australia
Phone 64794 0
+61 3 9496 5000
Fax 64794 0
Email 64794 0
matias.yudi@austin.org.au
Contact person for public queries
Name 64795 0
Dr Matias Yudi
Address 64795 0
Austin Health
Cardiology Department
145 Studley Road
PO BOX 5555
Heidelberg, VIC 3084
Country 64795 0
Australia
Phone 64795 0
+61 3 9496 5000
Fax 64795 0
Email 64795 0
matias.yudi@austin.org.au
Contact person for scientific queries
Name 64796 0
Dr Matias Yudi
Address 64796 0
Austin Health
Cardiology Department
145 Studley Road
PO BOX 5555
Heidelberg, VIC 3084
Country 64796 0
Australia
Phone 64796 0
+61 3 9496 5000
Fax 64796 0
Email 64796 0
matias.yudi@austin.org.au

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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: A randomized controlled trial protocol.2016https://dx.doi.org/10.1186/s12872-016-0356-6
N.B. These documents automatically identified may not have been verified by the study sponsor.