Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000251224
Ethics application status
Approved
Date submitted
3/03/2009
Date registered
12/05/2009
Date last updated
12/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of physical exercise adherence in a Home-Based Care Model for Outpatient Cardiac Rehabilitation based on Mobile Technologies.
Scientific title
Evaluation of physical exercise adherence in a Home-Based Care Model for Outpatient Cardiac Rehabilitation based on Mobile Technologies.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Outpatient, stage 2 cardiac rehabilitation of ST-Segment Elevation Myocardial Infarction (STEMI) or non-STEMI patients 4413 0
Condition category
Condition code
Cardiovascular 4673 4673 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a home based stage 2 cardiac rehabilitation based on information and communication technologies over 6 week mentoring program and 6 month follow-up period. Intervention involves: Pre-assessment and education at the care centre at the start of the 6 week program. Weekly 30 minute mentoring sessions via normal or video calls using the mobile phone involving education and goal setting. Mentoring includes exercise, diet, risk factors, stress and other behavioural counselling. Mentors can view patients self observations and measurement data such as walking activity on a web-portal prior the mentoring sessions. Patients will record daily measurements and self observations on the mobile phone regarding their weight, blood pressure, exercise, stress, diet, sleeping, smoking and alcohol use. Walking activity (steps) is automatically measured by the phone. All data is transferred to the web-portal that also the patient can access.
Patient will receive educational and motivational text- messages on the mobile phone 2 times per day. Patient is reminded to view educational video clips stored on the phone regarding cardiovascular disease, healthy lifestyle and risk factors. The phone includes relaxation audio files that the patient can listen to any time.
At the end of the 6week program there will be a post-assessment at the care centre and the mentoring sessions will not continue.
During the 6 month follow-up period the patients will continue to use the mobile phone and web-portal tools for self management. The patients can also use the care centre gym without supervison
Intervention code [1] 4152 0
Rehabilitation
Comparator / control treatment
Standard treatment is a community care centre based stage 2 cardiac rehabilitation program over 6 week gym-based group exercise program and 6 month follow-up period. The treatment involves: Pre-assessment and education at the care centre at the start of the 6 week program. 2 x 1hour exercise sessions per week at the community care centre gym including lifestyle and health education and goal setting. The exercise sessions are supervised by rehabilitation nurses and physiotherapists. At the end of the 6week program there will be a post-assessment at the care centre. During the 6month follow-up period the patients can continue using the care centre gym without supervison.
Control group
Active

Outcomes
Primary outcome [1] 5538 0
Primary Outcome: Physical exercise adherence.
Tools:
- Pedometer for 1/52
- 6 minute walk test
- Active Australia Survey, Australian Institute of Health and Welfare (AIHW)

The adherence will be assessed by:
- The daily steps and duration of walking activity measured with the pedometer during one week. Both the absolute activity levels and improvement are evaluated.
- Distance covered in the 6minute walk test. Both the absolute levels and improvement are evaluated.
- Duration and number of times spent in moderate and vigorous physical activities in a week from the Active Australia Survey. Both the absolute levels and improvement are evaluated.
Timepoint [1] 5538 0
At baseline, 6 weeks and 6 months after intevention commencement
Secondary outcome [1] 9326 0
Risk factors: Body Mass Index (BMI), blood pressure, smoking, alcohol intake, blood test: Full Blood Count (FBC), lipids, ratio of glycosylated hemoglobin in relation to the total hemoglobin (HbA1c), Haemoglobin.
Measured at the cardiac rehabilitation centre and Queensland Medical Laboratories according to standard procedures and recorded in a Cardiac Rehabilitation Assessment tool.
Timepoint [1] 9326 0
At baseline, 6 weeks and 6 months after intevention commencement
Secondary outcome [2] 9327 0
Psychological Functioning (Kessler 10)
Timepoint [2] 9327 0
At baseline, 6 weeks and 6 months after intevention commencement
Secondary outcome [3] 9328 0
Nutrition (Diet Habits Questionnaire )
Timepoint [3] 9328 0
At baseline, 6 weeks and 6 months after intevention commencement
Secondary outcome [4] 9329 0
Quality of Life with European Quality of Life-5 Dimensions (EQ-5D) Health Outcome questionnaire and The Seattle Angina Questionary
Timepoint [4] 9329 0
At baseline, 6 weeks and 6 months after intevention commencement
Secondary outcome [5] 9330 0
Medication Compliance (self report)
Timepoint [5] 9330 0
At baseline, 6 weeks and 6 months after intevention commencement
Secondary outcome [6] 9331 0
Satisfaction & Useability questionnaire
Timepoint [6] 9331 0
At baseline, 6 weeks and 6 months after intevention commencement
Secondary outcome [7] 9332 0
Morbidity and mortality.
Morbidity related to occurence of subsequent Acute Myocardial Infarction (AMI) and readmissions is obtained from the Queensland Health Hospital Based Computer Information System (HBCIS).
Timepoint [7] 9332 0
At 6 weeks and 6 months after intevention commencement
Secondary outcome [8] 9333 0
Process Indicators: 1) Costs (Staff time used in mentoring the intervention group and treatment of the control group is assessed through staff reports on Care Continuum Suite (CCS) system, projected equipment and facility costs are collected from the hospital's financial database, other technology costs are calculated from the project's financial records or estimated from the current market values), 2) Drop-out rates (from the trial recruitment spreadsheet updated by the project officer), 3) Median time return-to-work / Return to work (patient reports), 4)Numbers in control and intervention groups (from the trial recruitment spreadsheet updated by the project officer), 5)Numbers / percentage of people who did / did not consent to participate in the trial (from the trial recruitment spreadsheet updated by the project officer)
Timepoint [8] 9333 0
At 6 weeks and 6 months after intevention commencement

Eligibility
Key inclusion criteria
Acute myocardial infarction (STEMI or non-STEMI) and medically cleared to participate in Cardiac Rehabilitation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) High medical care needs (i.e. unable to participate in self management program)
2) No experience with mobile phone usage.
3) Inability to operate mobile phone (e.g. vision or hearing impairment, cognitive impairment, poor dexterity).
4) Current involvement in, or consent to participate in, any other medical trial involving clinical interventions. This will include involvement in the monitoring phase of any clinical trial

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4598 0
Other Collaborative groups
Name [1] 4598 0
Commonwealth Scientific and Industrial Rersearch Organisation (CSIRO), The Australian e-Health Research Centre
Country [1] 4598 0
Australia
Funding source category [2] 4599 0
Hospital
Name [2] 4599 0
Queensland Health
Country [2] 4599 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CSIRO, The Australian e-Health Research Centre
Address
Level 7, UQ CCR Building 71/918
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 4147 0
None
Name [1] 4147 0
Address [1] 4147 0
Country [1] 4147 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Clinical trial objective is to show evidence that Information and Communication Technology (ICT) enabled home-based care process of cardiac rehabilitation patients provides equally good or better outcomes than traditional hospital based rehabilitation processes not using ICT tools. The trial will potentially provide evidence that the new process is equally or more cost effective than traditional rehabilitation process.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29344 0
Address 29344 0
Country 29344 0
Phone 29344 0
Fax 29344 0
Email 29344 0
Contact person for public queries
Name 12591 0
Antti Sarela
Address 12591 0
Level 7, UQ CCR Building 71/918
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 12591 0
Australia
Phone 12591 0
+61 7 32533612
Fax 12591 0
Email 12591 0
[email protected]
Contact person for scientific queries
Name 3519 0
Antti Sarela
Address 3519 0
Level 7, UQ CCR Building 71/918
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 3519 0
Australia
Phone 3519 0
+61 7 32533612
Fax 3519 0
Email 3519 0
[email protected]

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
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