Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000166279
Ethics application status
Not yet submitted
Date submitted
4/02/2009
Date registered
3/04/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised control trial of an internet-based outpatient cardiac rehabilitation program
Scientific title
The efficacy of an internet-mediated cardiac rehabilitation program in increasing health-related phsycial activity participation in a sample of Phase II cardiac rehab patients
Universal Trial Number (UTN)
Trial acronym
eOCR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac rehabiliations 4270 0
Condition category
Condition code
Cardiovascular 4497 4497 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project involves the assessment of an electronic Outpatient Cardiac Rehabilitation (eOCR) platform, which was designed and developed by the research team at CQUniversity with the assistance of cardiac rehabilitation professionals. The platform is an internet-based educational content management system that provides the ‘online cardiac case manager’ with the ability to deliver interactive outpatient education, track patient progress by means of an online patient self-monitoring system and interact with the patient and/or their selected significant others within the security-protected web-based platform. The patient view of the eOCR site includes a ‘patient dashboard’ which is specifically tailored by the case manager for the participant to collect, track and display important health and behavioural measures. The site contains a library comprised of readings drawn from existing ‘best practice’ guidelines and the My Heart My Life publication by the Heart Foundation and a workbook that provides interactive educational activities relating to behavioral self management developed by the researchers in previous studies. The site also includes a variety of communication tools aimed at allowing patients to interact with their cardiac case manager, other patients and/or significant others that the patient has invited to take part (the support people are provided with their own login and home pages). Communication tools include email, discussion boards, and an integrated Voice over Internet Protocol (VoIP) programming link (Skype). The site also maintains records of the patient’s contact details and those of significant others as well as emergency contact details and protocols. The online cardiac case manager has a separate content/patient management structure, which allows them to track the progress in terms of readings, educational activities and patient self-report data for one or more patients concurrently. The case manager can also interact with the patients under their guidance by way of site email, discussion or VoIP. The current study assesses the efficacy of the use of the platform in the reduction of subsequent cardiovascular risk compared to individuals who undertake regular care. Participants progress at their own rate through a 12-week educational program
Intervention code [1] 3996 0
Rehabilitation
Comparator / control treatment
The overall study population is drawn from individuals who decline participation in existing conventional face-to-face cardiac rehabilitation. The control group are individuals in the ‘no treatment’ group who receive no other concurrent support. The control group will be assessed at baseline and 12 weeks post-baseline, at the same timepoints as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 5378 0
The primary outcome measure is the risk of recurrent coronary heart disease as assessed by the Framingham Risk Score
Timepoint [1] 5378 0
baseline and completion of intervention (12 weeks)
Secondary outcome [1] 9044 0
Functional Capacity measured by the Duke Activity Status Index
Timepoint [1] 9044 0
baseline and completion of intervention (12 weeks)

Eligibility
Key inclusion criteria
The key inclusion criteria are: eligibility for phase II cardiac rehabilitation program, living in an area serviced by broadband internet service provider and meeting American College of Sports Medicine (ACSM) guidelines for inclusion in physical activity/exercise
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
individuals who fail to meet ACSM exercise guidelines, patients with imparied ventricular function, patients with heart failure or controlled cardiac failure,arrythmisas, pacemaker, hostory of cariac arrest, preinz metal angina, uncontrolled diabetes

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not 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
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4452 0
Charities/Societies/Foundations
Name [1] 4452 0
Medical Benefits Fund (MBF) Foundation
Country [1] 4452 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
MBF Foundation
Address
50 Bridge St
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 4011 0
None
Name [1] 4011 0
Address [1] 4011 0
Country [1] 4011 0
Other collaborator category [1] 552 0
Hospital
Name [1] 552 0
Rockhampton Hospital
Address [1] 552 0
Canning Street ROCKHAMPTON QLD 4700
Country [1] 552 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6506 0
Human Research Ethics Committee
Ethics committee address [1] 6506 0
CQUniversity, Bruce Highway,
Rockhampton, QLD 4702
Ethics committee country [1] 6506 0
Australia
Date submitted for ethics approval [1] 6506 0
07/02/2009
Approval date [1] 6506 0
Ethics approval number [1] 6506 0

Summary
Brief summary
The overall objective of the project is to complete a randomised control trial to test the effectiveness and efficacy of an internet-based (electronic) outpatient cardiac rehabilitation program. Phase II outpatient cardiac rehabilitation patients who choose not to complete a face to face program will be invited to participate in the study. Patients willing and eligible for the study will have their baseline data collected and will then be randomised into either a 'Control' (or usual care) group or the 'Intervention' group. Control participants will undertake their intended usual care with no contact with the research team until follow-up. The Intervention participants will be provided with a laptop and internet connection (if necessary) for the period of the intervention. Participants will be encouraged to access the online program with monitoring via the online program by a cardiac rehabilitation case manager.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29250 0
Address 29250 0
Country 29250 0
Phone 29250 0
Fax 29250 0
Email 29250 0
Contact person for public queries
Name 12497 0
Mrs. Anetta VanItallie
Address 12497 0
Institute of Health and Social Science Research, CQUniversity Australia, Bruce Highway,
Rockhampton, QLD, 4702
Country 12497 0
Australia
Phone 12497 0
+61 7 4923 2171
Fax 12497 0
Email 12497 0
a.vanitallie@cqu.edu.au
Contact person for scientific queries
Name 3425 0
Prof. Kerry Mummery
Address 3425 0
Institute of Health and Social Science Research, CQUniversity Australia
Bruce Highway, Rockhampton, QLD, 4702
Country 3425 0
Australia
Phone 3425 0
+61 7 4930 6749
Fax 3425 0
Email 3425 0
k.mummery@cqu.edu.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.