Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000117910
Ethics application status
Approved
Date submitted
4/11/2010
Date registered
2/02/2011
Date last updated
25/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Heart Exercise And Remote Technologies Trial
Scientific title
A randomised controlled trial to determine the efficacy of an mobile (m)-health delivered exercise-based cardiac rehabilitation programme to increase exercise capacity and physical activity compared with usual care in New Zealand adults with a diagnosis of cardiovascular disease.
Secondary ID [1] 253091 0
Health Research Council 10-446
Universal Trial Number (UTN)
U1111-1117-7631
Trial acronym
HEART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 258589 0
Condition category
Condition code
Cardiovascular 258726 258726 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 258727 258727 0 0
Other physical medicine / rehabilitation
Public Health 258728 258728 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a m-health cardiac rehabilitation programme. Participants will receive a personalised automated package of text message components via their mobile phones to increase exercise behaviour delivered over 24 weeks. A total of 162 messages will be sent over 24 weeks. Participants will receive 1-2 messages per day for the first 6-weeks, then 8 messages per week from weeks 7-12 and then 4 messages per week from weeks 13-24. Participants will also have access to an interactive website which they may enter using a unique password and login. The website will be able to used at the participant's discretion and will contain messages sent to their phones which they can retrieve on demand, motivational messages, role model video clips, and weekly health and exercise tips.
Intervention code [1] 257554 0
Behaviour
Intervention code [2] 257610 0
Other interventions
Intervention code [3] 257958 0
Rehabilitation
Comparator / control treatment
The control group will be directed to receive usual care, which currently involves encouragement to be physically active and an offer to join a local cardiac club.
Control group
Active

Outcomes
Primary outcome [1] 259595 0
Change in maximal oxygen uptake (VO2max) from baseline to 24 weeks.
Timepoint [1] 259595 0
Baseline and 24 weeks
Secondary outcome [1] 266225 0
Physical function measured with the 6-minute walk test
Timepoint [1] 266225 0
Baseline and 24 weeks
Secondary outcome [2] 266226 0
Total physical activity (MET-minutes per week) measured with the International Physical Activity Questionnaire (IPAQ)
Timepoint [2] 266226 0
Baseline and 24 weeks
Secondary outcome [3] 266227 0
Health related quality of life (SF-36)
Timepoint [3] 266227 0
Baseline and 24 weeks
Secondary outcome [4] 266228 0
Cost-effectiveness - Cost information, including cost of programme, and direct medical costs (including cost of treatment, primary care, secondary care and over-the-counter medications) and Quality Adjusted Life Year (QALY).
Timepoint [4] 266228 0
24 weeks

Eligibility
Key inclusion criteria
1. A clinically documented diagnosis of ischaemic heart disease (angina, myocardial infarction, revascularisation, including angioplasty, stent or coronary artery bypass graft) within the previous three to twelve months;
2. A current outpatient and is clinically stable
3. Able to perform exercise;
4. Able to understand and write English;
5. Own a mobile phone and have access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have been admitted to hospital with heart disease within the previous 6 weeks;
2. Have terminal cancer;
3. Have significant exercise limitations other than CVD, or currently meet the recommendations for regular physical activity (150 min/week moderate intensity activity).

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 recruited from two metropolitan hospitals in Auckland. Cardiac rehabilitation (CR) nurses will identify eligible and interested participants from the existing database. CR nurses will screen patients according to the eligibility criteria. Contact details for those eligible and interested in participating will be forwarded to the research team, who will make contact to enrol them in the study and organise baseline assessments.

Following baseline assessment procedures, participants will be randomly assigned to either an m-health exercise-based CR intervention or the usual CR control group using the a central computerised randomisation service. Researchers will use laptop computers to randomise participants on-site; therefore allocation concealment will be maintained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using the a central computerised randomisation service. A minimisation method will be considered using three stratification factors: sex (female and male), self-identified ethnicity (Maori and non-Maori), and adherence to Phase 2 CR (attended at least one session or not).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment outside Australia
Country [1] 3017 0
New Zealand
State/province [1] 3017 0

Funding & Sponsors
Funding source category [1] 258005 0
Government body
Name [1] 258005 0
Health Research Council
Country [1] 258005 0
New Zealand
Primary sponsor type
Individual
Name
Ralph Maddison
Address
Clinical Trials Research Unit
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 257200 0
None
Name [1] 257200 0
Address [1] 257200 0
Country [1] 257200 0
Other collaborator category [1] 251641 0
Hospital
Name [1] 251641 0
Auckland City Hospital
Address [1] 251641 0
2 Park Road
Grafton 1010, Auckland
Country [1] 251641 0
New Zealand
Other collaborator category [2] 251642 0
Hospital
Name [2] 251642 0
Middlemore Hospital
Address [2] 251642 0
Private Bag 93311
Otahuhu
Auckland 1640
Country [2] 251642 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260001 0
Northern X Regional Ethics Committee
Ethics committee address [1] 260001 0
Northern X Ethics Committee
3rd floor, Unisys building
650 Great South Rd
Penrose, 1061
Auckland
Ethics committee country [1] 260001 0
New Zealand
Date submitted for ethics approval [1] 260001 0
15/09/2010
Approval date [1] 260001 0
06/11/2010
Ethics approval number [1] 260001 0
NTX/10/10/099

Summary
Brief summary
Exercise is the cornerstone of cardiac rehabilitation for people with heart disease. However many of those with heart disease do not undertake sufficient levels of exercise, and therefore do not realise the benefits, such as increased cardiovascular fitness, decreased weight and improved lipid profile. The proposed study aims to improve existing exercise based cardiac rehabilitation provision using a (m)-health delivery approach. One hundred and seventy participants will be allocated at random to receive a package of exercise prescription and behavioural support strategies via mobile phone and internet (m-health) for 6 months or usual care (advice to be physically active and encouragement to join a cardiac club). Assessments at baseline and 6-months will compare physical fitness, exercise levels, and quality of life in the different groups. If effective, this approach has enormous potential to improve the delivery of cardiac rehabilitation and could be scaled up nationally and internationally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31874 0
Address 31874 0
Country 31874 0
Phone 31874 0
Fax 31874 0
Email 31874 0
Contact person for public queries
Name 15121 0
Karen Carter
Address 15121 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country 15121 0
New Zealand
Phone 15121 0
0064 9 3737 599 ext 84767
Fax 15121 0
Email 15121 0
kh.carter@ctru.auckland.ac.nz
Contact person for scientific queries
Name 6049 0
Ralph Maddison
Address 6049 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country 6049 0
New Zealand
Phone 6049 0
0064 9 3737 599 ext 82368
Fax 6049 0
Email 6049 0
r.maddison@ctru.auckland.ac.nz

No information has been provided regarding IPD availability


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Results publications and other study-related documents

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