Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000014358
Ethics application status
Approved
Date submitted
8/01/2008
Date registered
11/01/2008
Date last updated
11/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Young @ Heart: A randomised controlled trial of a multi-disciplinary home based healthcare program for cardiac patients in the private healthcare system
Scientific title
A randomised controlled study of a multi-disciplinary home based health care program for cardiac patients in the private healthcare sector to reduce the rate of re-hospitalisation
Secondary ID [1] 253426 0
Young @ Heart Study
Universal Trial Number (UTN)
Trial acronym
Young@Heart
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 2677 0
Condition category
Condition code
Cardiovascular 2801 2801 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention involves a nurse coordinated multidisciplinary intervention with home visits involving clinical assessment, medication knowledge and assessment, overall self-care abilities, social status and current use of health care resources. Home visits occur within 2 weeks of discharge from hospital and this will be performed over the initial 6 months with median follow-up for 2.5 years. Each visit will be of 1 to 1.5 hours duration.
Intervention code [1] 2419 0
Behaviour
Intervention code [2] 2420 0
Lifestyle
Comparator / control treatment
Usual care following hospital discharge which involves General Practitioners (GP) follow-up, out-patients appointment with specialist physician as required.
Control group
Active

Outcomes
Primary outcome [1] 3689 0
Rate of all-cause hospital stay
Timepoint [1] 3689 0
Mean of 2.5 years follow-up following initial hospital admission.
Secondary outcome [1] 6225 0
Cost per Quality Adjusted Life Years (QALY)- [a commonly used instrument used in health economics] and cardiac-related hospitalisation
Timepoint [1] 6225 0
Mean follow-up of 2.5 years following inital hospital admission
Secondary outcome [2] 6226 0
Individual quality of life, functional status and overall healthcare satisfaction. The tools used will be the SF-12 for quality of life, the Montreal Cognitive Assessment Tool to examine cognitive function and the EQ-5D and CES-Depression scale to examine mental health status.
Timepoint [2] 6226 0
Over 3 years follow-up period

Eligibility
Key inclusion criteria
All elective and emergency patients admitted to St Andrews or Wesley Hospital, Brisbane and have MBF private health insurance, discharged to home and diagnosed with chronic heart disease: Coronary artery disease, chronic heart failure and chronic atrial fibrillation.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those < 45 years, not in the three diagnostic groups, not being discharged home, have congenital heart condition, a terminal malignancy, live beyond 25 km of the hospital or have surgically repairable heart disease.

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)
A blinded, randomisation protocol (using SPSS 14.0) via Preventative Cardiology at the Baker Heart Research Institute, will allocate eligible patients to the study intervention or usual care (on a 1:1 basis) (Central randomisation). Randomisation will only occur after informed consent has been obtained from eligible patients and via a blinded protocol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Based on 1:1 randomization and 85% power (two-sided alpha of 0.05), we calculated that 300 patients in each group (600 in total) would be sufficient to detect an absolute 20% difference in the primary outcome.
Between group (univariate) comparisons were assessed by Student’s t-tests, Mann Whitney U test (for non-normally distributed continuous data) and Chi-squared test (with calculation of odd ratio’s [OR] and 95% confidence intervals [CI’s]) where appropriate. All-cause mortality and event-free survival data were initially analyzed using Kaplan Meier survival curves. Hospital costs were calculated per patient per day of study follow-up. All costs are expressed in 2011/12 Australian dollars (AU$1.00 ˜ US$1.00). Backward, step-wise Cox proportional hazards models (including baseline demographic and clinical profile data) were constructed to examine the independent impact of group allocation on: i) event-free survival from all-cause death or hospitalization, ii) all-cause mortality and iii) event-free survival from cardiovascular-related hospitalization. Analyses were also performed on a sex-specific basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
17/06/2008
Date of last participant enrolment
Anticipated
Actual
14/01/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
602
Accrual to date
Final
602
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 718 0
4000

Funding & Sponsors
Funding source category [1] 2938 0
Commercial sector/Industry
Name [1] 2938 0
Bupa Australia
Country [1] 2938 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
Preventive Cardiology
75 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 2652 0
Commercial sector/Industry
Name [1] 2652 0
Bupa Health Fundation
Address [1] 2652 0
600 Glenferrie Road
HAWTHORN VIC 3122
Country [1] 2652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4883 0
Uniting Hospitals Ethics Committee
Ethics committee address [1] 4883 0
Ethics committee country [1] 4883 0
Australia
Date submitted for ethics approval [1] 4883 0
Approval date [1] 4883 0
29/11/2007
Ethics approval number [1] 4883 0
2000773

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28278 0
Prof Simon Stewart
Address 28278 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 28278 0
Australia
Phone 28278 0
+61399533677
Fax 28278 0
+61396635726
Email 28278 0
[email protected]
Contact person for public queries
Name 11435 0
Melinda Carrington
Address 11435 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 11435 0
Australia
Phone 11435 0
+61399533688
Fax 11435 0
+61396635726
Email 11435 0
[email protected]
Contact person for scientific queries
Name 2363 0
Melinda Carrington
Address 2363 0
Mary MacKillop Institute for Health Research, Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
Country 2363 0
Australia
Phone 2363 0
+61399533688
Fax 2363 0
+61396635726
Email 2363 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCost-effectiveness of a home based intervention for secondary prevention of readmission with chronic heart disease.2015https://dx.doi.org/10.1371/journal.pone.0144545
N.B. These documents automatically identified may not have been verified by the study sponsor.